Prospective study of oral teicoplanin versus oral vancomycin for therapy of pseudomembranous colitis and Clostridium difficile-associated diarrhea. Clostridium difficile pilot study: effects of probiotic supplementation on the incidence of C. difficile diarrhoea. Antibiotic-associated colitis due to Clostridium difficile: double-blind comparison of vancomycin with bacitracin. Prevention of antibiotic-associated diarrhea by Saccharomyces boulardii: a prospective study. [Duration of the preventive use of antibiotics in colorectal surgery--single administration versus short-term prevention]. Treatment of antibiotic-associated Clostridium difficile colitis with oral vancomycin: comparison of two dosage regimens. Single-dose peroperative antibiotic prophylaxis in gastrointestinal surgery. A randomized prospective study to compare cefotetan with cefuroxime plus metronidazole as prophylaxis in elective colorectal surgery. Prospective, randomised study on antibiotic prophylaxis in colorectal surgery. Is it really necessary to use oral antibiotics? Prospective randomised trial of metronidazole versus vancomycin for Clostridium-difficile-associated diarrhoea and colitis. Antibiotic treatment during surgery for diffuse peritonitis: a prospective randomized study comparing the effects of cefuroxime and of a cefuroxime and metronidazole combination. [Comparative analysis of mezlocillin/metronidazole and amoxicillin/clavulanic acid as "one shot" preventive antibiotic administration in colorectal interventions]. Successful control of Clostridium difficile infection in an elderly care unit through use of a restrictive antibiotic policy. Should antimicrobial prophylaxis in colorectal surgery include agents effective against both anaerobic and aerobic microorganisms? A double-blind, multicenter study. The Norwegian Study Group for Colorectal Surgery. Lactobacillus plantarum 299v reduces colonisation of Clostridium difficile in critically ill patients treated with antibiotics. Impact of changes in antibiotic policy on Clostridium difficile-associated diarrhoea (CDAD) over a five-year period in a district general hospital. A prospective randomized study of prophylactic antibiotics in elective laparoscopic cholecystectomy. Clinical trial of prophylaxis of wound sepsis in elective colorectal surgery comparing ticarcillin with tinidazole. University of Melbourne Colorectal Group. Prevention of wound infection in elective colorectal surgery by local application of a gentamicin-containing collagen sponge. Prophylactic Lactobacillus GG reduces antibiotic-associated diarrhea in children with respiratory infections: a randomized study. Randomised controlled trial of vancomycin for pseudomembranous colitis and postoperative diarrhoea. The search for a better treatment for recurrent Clostridium difficile disease: use of high-dose vancomycin combined with Saccharomyces boulardii. Double-blind comparison of single-dose alatrofloxacin and cefotetan as prophylaxis of infection following elective colorectal surgery. Trovafloxacin Surgical Group. Systemic Timentin is superior to oral tinidazole for antibiotic prophylaxis in elective colorectal surgery. University of Melbourne Colorectal Group. Single-dose intravenous metronidazole v. doxycycline prophylaxis in colorectal surgery. An open prospective, randomized trial. Comparison of systemic prophylaxis with metronidazole/placebo and metronidazole/fosfomycin in colorectal surgery. A clinical study demonstrating the need for additional anti-aerobic prophylactic cover. Treatment of Clostridium difficile associated diarrhea and colitis with an oral preparation of teicoplanin; a dose finding study. The Swedish CDAD Study Group. Single-dose chemoprophylaxis in elective colorectal surgery. A comparison between doxycycline plus metronidazole and doxycycline. [Antibiotic prophylaxis in colon surgery: cefazolin (Kefzol- ornidazole (Tiberal) versus cephazolin-placebo]. Single dose cefuroxime/metronidazole versus metronidazole alone in elective colorectal surgery. Metronidazole vs. erythromycin, neomycin, and cefazolin in prophylaxis for colonic surgery. Oral bacitracin vs vancomycin therapy for Clostridium difficile-induced diarrhea. A randomized double-blind trial. A prospective comparison of gentamicin and metronidazole and moxalactam in the prevention of septic complications associated with elective operations of the colon and rectum. Oral supplementation with lactic acid-producing bacteria during intake of clindamycin. Colectomy, mucosal proctectomy, and ileal pouch-anal anastomosis. A prospective trial of optimal antibiotic management. A randomized placebo-controlled trial of Saccharomyces boulardii in combination with standard antibiotics for Clostridium difficile disease. Effect of topical antibiotic therapy on recovery after tonsillectomy in adults. Prophylactic single-dose fosfomycin and metronidazole compared with neomycin, bacitracin, metronidazole and ampicillin in elective colorectal operations. Comparison of short-term antibiotic cover with a third-generation cephalosporin against conventional five-day therapy using metronidazole with an aminoglycoside in emergency and complicated colorectal surgery. Ertapenem versus cefotetan prophylaxis in elective colorectal surgery. A randomized trial to compare amoxycillin/clavulanate with metronidazole plus gentamicin in prophylaxis in elective colorectal surgery. Effectiveness of prophylactic antibiotic treatment in mastoid surgery. [Parenteral antibiotic prophylaxis or oral antimicrobial bowel preparation for colorectal surgery (author's transl)]. Value of oral antibiotic prophylaxis in colorectal surgery. Use of probiotic Lactobacillus preparation to prevent diarrhoea associated with antibiotics: randomised double blind placebo controlled trial. [Use of cephalosporins as antibiotic prophylaxis in cesarean section]. Comparison between oral and systemic antibiotics and their combined use for the prevention of complications in colorectal surgery. Single dose cefotaxime plus metronidazole versus three dose cefuroxime plus metronidazole as prophylaxis against wound infection in colorectal surgery: multicentre prospective randomised study. Saccharomyces boulardii in the prevention of antibiotic-associated diarrhoea in children: a randomized double-blind placebo-controlled trial. The lack of therapeutic effect of Saccharomyces boulardii in the prevention of antibiotic-related diarrhoea in elderly patients. Short-term antibiotic prophylaxis in elective colorectal surgery. Meropenem versus imipenem/cilastatin in the treatment of intraabdominal infections requiring surgery. Oral versus systemic antibiotic prophylaxis in elective colon surgery: a randomized study and meta-analysis send a message from the 1990s. Measuring the saving attributable to an antibiotic prescribing policy. Oral prophylaxis with neomycin and erythromycin in colorectal surgery. More proof for efficacy than failure. Randomized controlled trial of intraoperative goal-directed fluid therapy in aerobically fit and unfit patients having major colorectal surgery. Decrease in nosocomial Clostridium difficile-associated diarrhea by restricting clindamycin use. Selective decontamination of the colon before elective colorectal surgery. West of Scotland Surgical Infection Study Group. Dose-response efficacy of a proprietary probiotic formula of Lactobacillus acidophilus CL1285 and Lactobacillus casei LBC80R for antibiotic-associated diarrhea and Clostridium difficile-associated diarrhea prophylaxis in adult patients. A prospective, randomized trial of perioperative prophylactic cefamandole in elective colorectal surgery for malignancy. Is mechanical bowel preparation mandatory for elective colon surgery? A prospective randomized study. The reduction of radiation mucositis by selective decontamination antibiotic pastilles: a placebo-controlled double-blind trial. Hospital-wide restriction of clindamycin: effect on the incidence of Clostridium difficile-associated diarrhea and cost. Multicenter comparison of cefoxitin versus cefazolin for prevention of infectious morbidity after nonelective cesarean section. Single or multiple doses of metronidazole and ampicillin in elective colorectal surgery. A randomized trial. Nitazoxanide for the treatment of Clostridium difficile colitis. Does prophylactic administration of systemic antibiotics prevent postoperative inflammatory complications after third molar surgery? Prophylactic antibiotics in elective colorectal surgery. [Mechanical preparation in elective colorectal surgery, a usual practice or a necessity?]. Effect of Lactobacillus rhamnosus GG in persistent diarrhea in Indian children: a randomized controlled trial. Clinical trial: effectiveness of Lactobacillus rhamnosus (strains E/N, Oxy and Pen) in the prevention of antibiotic-associated diarrhoea in children. Perioperative antibiotic prophylaxis is cesarean section. Comparison of two prophylactic single-dose intravenous antibiotic regimes in the treatment of patients undergoing elective colorectal surgery in a district general hospital. The effect of placental removal method on the incidence of postcesarean infections. Cranberry or trimethoprim for the prevention of recurrent urinary tract infections? A randomized controlled trial in older women. Cefoxitin for one day vs. ampicillin and metronidazole for three days in elective colorectal surgery. A prospective, randomized, multicenter study. A randomized trial of one versus three doses of Augmentin as wound prophylaxis in at-risk abdominal surgery. Antibiotics in elective colon surgery. A randomized trial of oral, systemic, and oral/systemic antibiotics for prophylaxis. Prophylactic metronidazole in appendicectomy: a controlled trial. Timing of antibiotic prophylaxis with cefotaxime for prostatic resection: better in the operative period or at urethral catheter removal? Randomized controlled study of in-hospital exercise training programs in children with cystic fibrosis. Albuterol delivered by metered-dose inhaler to treat acute bronchitis. Comparison of oral amoxicillin and intravenous benzyl penicillin for community acquired pneumonia in children (PIVOT trial): a multicentre pragmatic randomised controlled equivalence trial. Do cancer patients with chemotherapy-induced leukopenia benefit from an antiseptic chlorhexidine-based oral rinse? A double-blind, block-randomized, controlled study. Physical conditioning and mental stress reduction--a randomised trial in patients undergoing cardiac surgery. Single dose imipenem-cilastatin compared with three doses of cefuroxime and metronidazole as prophylaxis in elective colorectal surgery: a prospective randomized study. Favorable impact of a multidisciplinary antibiotic management program conducted during 7 years. Topical ampicillin in addition to a systemic antibiotic prophylaxis in elective colorectal surgery. A prospective randomized study. Impact of a multipronged education strategy on antibiotic prescribing in Quebec, Canada. Short-term versus long-term cefuroxime prophylaxis in patients undergoing emergency cesarean section. Prophylaxis of infection following colorectal surgery. Intake of Lactobacillus plantarum reduces certain gastrointestinal symptoms during treatment with antibiotics. Low-dose, single-shot perioperative antibiotic prophylaxis in colorectal surgery. [Comparison of the therapeutic efficacy of the piperacillin/tazobactame combination vs. ampicillin and gentamycin in in the management of post-cesarean endometritis]. Imipenem (N-F-thienamycin) versus netilmicin plus clindamycin. A controlled and randomized comparison in intra-abdominal infections. Mucositis reduction by selective elimination of oral flora in irradiated cancers of the head and neck: a placebo-controlled double-blind randomized study. Is neomycin necessary for bowel preparation in surgery of the colon? Oral neomycin plus erythromycin versus erythromycin-metronidazole. Postoperative infections in colonic surgery after enteral bacitracin-neomycin-clindamycin or parenteral mezlocillin-oxacillin prophylaxis. Prophylactic antibiotics in surgery for chronic ear disease. Optimizing antibiotic prescribing for acute cough in general practice: a cluster-randomized controlled trial. Preoperative cell-mediated immunity and duration of antibiotic prophylaxis in relation to postopertive infectious complications. A controlled trial in biliary, gastroduodenal and colorectal surgery. Efficacy of prophylactic antibiotics for dental implants: a multicentre placebo-controlled randomised clinical trial. Comparison of one dose versus three doses of prophylactic antibiotics, and the influence of blood transfusion, on infectious complications in acute and elective colorectal surgery. Prophylactic antibiotics for elective colorectal surgery or operation for obstruction of the small bowel: a comparison of cefonicid and cefoxitin. An observer blind trial of co-amoxiclav versus cefuroxime plus metronidazole in the prevention of postoperative wound infection after general surgery. Multicenter study of aztreonam in the prophylaxis of colorectal, gynecologic and urologic surgery. Comparison of two different daily dosages (2.4 vs. 1.2 g) of oral mesalazine in maintenance of remission in ulcerative colitis patients: 1-year follow-up study. Short-term antibiotic prophylaxis in high-risk patients following cesarean section. A double-blind comparison of balsalazide, 6.75 g daily, and sulfasalazine, 3 g daily, in patients with newly diagnosed or relapsed active ulcerative colitis. Prophylactic antibiotics for elective laparoscopic cholecystectomy: are they necessary? Prophylactic lincomycin in the prevention of wound infection following appendicectomy: a double blind study. Role of preoperative antibiotic prophylaxis in preventing postoperative peritonitis in newly placed peritoneal dialysis catheters. A comparison of aztreonam/metronidazole and cefotaxime/metronidazole in elective colorectal surgery: antimicrobial prophylaxis must include gram-positive cover. The prophylactic use of metronidazole in caesarean section. Comparison of metronidazole with doxycycline prophylaxis in elective colorectal surgery. A prospective, randomized multicentre study. [Short-term antibiotic prophylaxis in colorectal surgery: cefoxitin versus piperacillin. A double-blind randomized study, 60 cases]. Randomised controlled trial of intravenous antibiotic treatment for cellulitis at home compared with hospital. Postcesarean analgesia: the efficacy of bupivacaine wound instillation with and without supplemental diclofenac. Conservative management of acute appendicitis. Evaluation of the role of prophylactic antibiotics in elective laparoscopic cholecystectomy: a prospective randomized trial. Duration of antimicrobial prophylaxis in vascular surgery. Optimal duration of antibiotic therapy for uncomplicated urinary tract infection in older women: a double-blind randomized controlled trial. Prophylactic antibiotics in vascular surgery. Topical, systemic, or both? Efficacy of Clostridium butyricum preparation concomitantly with Helicobacter pylori eradication therapy in relation to changes in the intestinal microbiota. Bloodstream infections: a trial of the impact of different methods of reporting positive blood culture results. Does preoperative core needle biopsy increase surgical site infections in breast cancer surgery? Randomized study of antibiotic prophylaxis. A comparison of single-dose systemic Timentin with mezlocillin for prophylaxis of wound infection in elective colorectal surgery. University of Melbourne Colorectal Group. Comparison of vancomycin, teicoplanin, metronidazole, and fusidic acid for the treatment of Clostridium difficile-associated diarrhea. The prevention of emesis in plastic surgery: a randomized, prospective study. Optimum duration of oral adjuvant chemotherapy of HCFU for colorectal cancer; review of 5-year follow-up. Antibiotic prophylaxis in operations on trochanteric femoral fractures. Effect of prophylactic antibiotics on morbidity associated with IUD insertion: results of a pilot randomized controlled trial. IUD Study Group. Effect of zinc supplementation on incidence of infections and hospital admissions in sickle cell disease (SCD). [Perioperative antibiotic prophylaxis in colon surgery. Metronidazole and tobramycin versus metronidazole alone. A prospective randomized study]. Prophylactic antibiotics in uncomplicated appendicitis during childhood--a prospective randomised study. Effect of caseload on the short-term outcome of colon surgery: results of a multicenter study. Selective decontamination of the digestive tract to prevent postoperative infection: a randomized placebo-controlled trial in liver transplant patients. Oral, nonabsorbable antibiotics prevent infection in cirrhotics with gastrointestinal hemorrhage. Post-ERCP pancreatitis: reduction by routine antibiotics. Oral misoprostol for premature rupture of membranes at term. Randomized trial of oral versus intravenous antibiotics in low-risk febrile neutropenic patients with lung cancer. Prospective randomized clinical trial assessing the efficacy of a short course of intravenously administered amoxicillin plus clavulanic acid followed by oral antibiotic in patients with uncomplicated acute diverticulitis. Failure of single-dose metronidazole prophylaxis in colorectal surgery. No benefit from high dosage or combination with nalidixic acid. Peroperative systemic prophylaxis in colorectal surgery. Bacteremia and bacterascites after endoscopic sclerotherapy for bleeding esophageal varices and prevention by intravenous cefotaxime: a randomized trial.
A prospective, randomized study comparing oral teicoplanin with oral vancomycin in the treatment of pseudomembranous colitis (PMC) and Clostridium difficile-associated diarrhea (CDAD) was performed. Teicoplanin was administered at a dosage of 100 mg twice a day for 10 days, and vancomycin was administered at a dosage of 500 mg four times a day for 10 days. CDAD was diagnosed by demonstrating both C. difficile and cytotoxin in the feces of symptomatic patients (more than three loose stools per day). The diagnosis of PMC was also based on colonoscopy. Cytotoxin assay and cultures were checked in all patients 7 to 10 days after discontinuation of therapy and 25 to 30 days thereafter. Of the 51 patients enrolled, 46 were judged to be assessable. Among these, 26 received teicoplanin and 20 received vancomycin. At enrollment, both groups were comparable in terms of age, sex, occurrence of PMC or CDAD, and previous antibiotic treatment. Eighteen of the 20 patients in the vancomycin group and 10 of the 26 patients in the teicoplanin group had previously undergone surgery (P = 0.0004). Treatment resulted in the clinical cure of 20 (100%) vancomycin and 25 (96.2%) teicoplanin patients (P = 0.56). After discontinuation of therapy, clinical symptoms recurred in four (20%) vancomycin patients and two (7.7%) teicoplanin patients (P = 0.21). Posttherapy asymptomatic C. difficile carriage (positive follow-up cultures without any clinical symptoms) occurred in five (25%) vancomycin patients and two (7.7%) teicoplanin patients (P = 0.11).Overall, 9 of 20 (45%) vancomycin patients and 5 of 26 (19.2%) teicoplanin patients (P=0.059) appeared not to be cleared of C. difficile after treatment. No adverse effects related to vancomycin or teicoplanin therapy were observed. Colonic infection with Clostridium difficile, leading to pseudomembranous colitis, is a common complication of antibiotic therapy, especially in elderly patients. It has been suggested that non-pathogenic probiotic bacteria might prevent the development and recurrence of C. difficile infection. This double-blind, placebo-controlled study examines the role of probiotic administration in the prevention of C. difficile-associated diarrhoea (CDAD) in elderly patients receiving antibiotic therapy. Consecutive patients (150) receiving antibiotic therapy were randomised to receive either a probiotic containing both Lactobacillus and Bifidobacterium or placebo for 20 days. Upon admission to hospital, bowel habit was recorded and a faecal sample taken. Trial probiotic or placebo was taken within 72 h of prescription of antibiotics, and a second stool sample was taken in the event of development of diarrhoea during hospitalisation or after discharge. Of the randomised patients, 138 completed the study, 69 with probiotics in conjunction with antibiotics and 69 with antibiotics alone. On the basis of development of diarrhoea, the incidence of samples positive for C. difficile-associated toxins was 2.9% in the probiotic group compared with 7.25% in the placebo-control group. When samples from all patients were tested (rather than just those developing diarrhoea) 46% of probiotic patients were toxin-positive compared with 78% of the placebo group. A randomized double-blind study was carried out in patients with unresolving antibiotic-associated colitis due to Clostridium difficile, to compare the effect of bacitracin (80,000 U/day) with vancomycin (500 mg/day) on the resolution of symptoms, clearance of organism, and prevention of relapse. Forty-two patients with colitis, 9 of whom had a pseudomembrane, were randomized, 21 patients to each treatment group. The two groups were comparable in age, disease severity, and antibiotic exposure. For a 50% reduction in stool frequency the mean times (+/- SE) were 4.1 +/- 0.4 days for bacitracin and 4.2 +/- 0.4 days for vancomycin. Sixteen patients (76%) had symptom resolution after 7 days of treatment with bacitracin, compared with 18 patients (86%) given vancomycin. Patients who failed to respond were crossed over (blind) to the alternative antibiotic, but tended to be refractory to the alternative medication as well. Vancomycin-treated patients had negative toxin (83% vs. 53%, p = 0.04) and negative stool cultures (81% vs. 52%, p = 0.02) more frequently than did those patients given bacitracin. Similar numbers of patients in each group had symptomatic relapse during 1 mo of follow-up, but most of them relapsed yet again after blinded crossover therapy. Although bacitracin was significantly less effective than vancomycin in clearing C. difficile from the stools, both were of similar value in the control of symptoms in a group of patients with predominantly nonpseudomembranous colitis. In view of its low cost, bacitracin is a reasonable first-line alternative to vancomycin in the treatment of antibiotic-associated colitis. Saccharomyces boulardii, a nonpathogenic yeast, has been widely used in Europe to prevent antibiotic-associated diarrhea (AAD). We performed a prospective double-blind controlled study to investigate AAD in hospitalized patients and to evaluate the effect of S. boulardii, a living yeast, given in capsule form concurrently with antibiotics. Over 23 mo, 180 patients completed the study. Of the patients receiving placebo, 22% experienced diarrhea compared with 9.5% of patients receiving S. boulardii (p = 0.038). Risk factors found to be associated with AAD were multiple antibiotic combinations (containing clindamycin, cephalosporins, or trimethoprim-sulfamethoxazole) and tube feeding. Clostridium difficile, an anaerobe found in the stools of most patients with pseudomembranous colitis, was variably associated with AAD. We evaluated the role of C. difficile in AAD in the study population and found no significant association between the presence of C. difficile or cytotoxin with AAD. Approximately 33% of the patients without diarrhea harbored at least one C. difficile-positive stool and nearly 50% of these patients had detectable cytotoxin. Similar values were obtained in patients with diarrhea. Of C. difficile-positive patients, 31% (5/16) on placebo developed diarrhea compared with 9.4% (3/32) on S. boulardii; this difference was not statistically significant (p = 0.07). There were no discernable adverse effects of yeast administration. We conclude that S. boulardii reduces the incidence of antibiotic-associated diarrhea in hospitalized patients. The effect of a combination of 4 g mezlocillin and 0.5 g metronidazole for the prophylaxis against infections in a one-shot dose immediately preoperatively compared to a short-time dose of 2 days given to 90 patients with resection of colorectal carcinoma was investigated in a prospective and randomized study. 6 patients developed a wound infection in the early postoperative phase; 4 of these infections (3 were severe, 1 was mild) occurred in the one-shot group and 2 in the short-time prophylaxis group. After more than 20 days postoperatively 3 late infections were observed which had a mild course (2 cases in the one-shot group, 1 case in the short-time prophylaxis group). All infections were localized in the sacral wound region in patients with abdominoperineal resection. The abdominal wounds healed per primam in each case. Besides those, 26 infections of the urinary tract were observed, which occurred significantly more often after the one-shot dose (40.9%) than with the short-time prophylaxis (18.6%). Intraoperative smears of the lumen of the bowels showed a remaining bacterial settlement. Besides Bacteroides species, especially Escherichia coli were found among the isolates. Moreover in some cases Clostridium, Klebsiella, Proteus and Pseudomonas could be identified. Smears of the site of operation (sacral/peritoneal cavity) were contaminated in over 50%, above all by Bacteroides species; besides those, E. coli were found most often. The subcutaneous smears showed a growth of the germs only in a few cases. Aerobic bacteria in 93.8%, anaerobic bacteria except for thetaiotaomicron and B. asaccharolyticus in 85.1%.(ABSTRACT TRUNCATED AT 250 WORDS) High-dose (500 mg orally four times daily) vancomycin is considered by many investigators to be the most effective treatment for antibiotic-associated Clostridium difficile colitis. However, a lower dosage of 125 or 150 mg given three or four times a day has become popular, has been shown to be effective, and is less expensive than the high-dose regimen. We therefore decided to compare two vancomycin dosage regimens in a randomized trial.
                The study involved 46 hospitalized patients with serious underlying diseases complicated by C. difficile diarrhea or colitis. Patients were assigned (according to a table of random numbers) to treatment with either 125 or 500 mg of vancomycin orally four times daily for an average of 10 days.
                No significant differences in measurable responses to the two regimens were noted. There were no treatment failures. The mean duration of diarrhea after initiation of therapy was about four days, and almost all patients had no diarrhea after one week. The organism continued to be demonstrated in the stools of about 50 percent of patients for the first few weeks after completion of therapy, and nine (20 percent) patients developed a recurrence of their diarrheal illness. Vancomycin was well tolerated by all patients.
                Since the dose of 125 mg appeared to be as effective as the 500-mg dose, which is more expensive, the 125-mg dose is preferred when vancomycin is used in treatment of this disease, unless the patient is critically ill. A single intravenous dose of tobramycin and lincomycin, given at the start of gastrointestinal operations, significantly reduced the incidence of postoperative wound infection from 34% to 5%. The occurrence of both anaerobic and aerobic bacteria was reduced. Therapeutic concentrations of the antibiotics were maintained throughout the operative period in most cases. No toxic effects of the antibiotics were detected, no anaesthetic complication occurred, and resistant strains of bacteria normally sensitive to the antibiotics were not isolated from wounds. This study compares the efficacy of cefotetan with the combination of cefuroxime plus metronidazole as antibiotic prophylaxis in elective colorectal surgery when given over the first 24 h postoperatively. There was no significant difference in wound infection rates between the two groups (14.7% for cefotetan and 13.9% for cefuroxime plus metronidazole), or the rates of other infective complications. Adverse reactions occurred with equal frequency in both treatment groups and no serious side effects occurred. Cefotetan is a safe and effective antibiotic for use as prophylaxis in elective colorectal surgery. Its advantages are that it is a single agent with a spectrum covering both aerobic Gram-negative rods and anaerobic organisms and, because of its long half-life, needs only to be given at 12-hourly intervals. The use of prophylactic antibiotics in addition to mechanical cleansing is the current standard of care prior to colonic surgery. The question of whether the antibiotics should be administered intravenously or orally, or by both routes, remains controversial. Our aim was to compare three methods of prophylactic antibiotic administration in elective colorectal surgery.
                Three hundred consecutive elective colorectal resections were studied. All patients had preoperative mechanical colon cleansing with oral sodium phosphate and intravenous antibiotic prophylaxis with cefoxitin (one dose before skin incision and two postoperative doses). Patients were randomised to one of the following three groups: group A: three doses of oral antibiotic (neomycin and metronidazole) at the time of mechanical colon cleansing; group B: one dose of oral antibiotic; group C: no oral antibiotics. All patients were followed during their hospital stay and at 7, 14 and 30 days post-surgery.
                Vomiting occurred in 31%, 11% and 9% of the studied patients (groups A, B and C, respectively) (p<0.001). Nausea was present in 44%, 18% and 13% of patients (p<0.001). Abdominal pain was recorded in 13%, 10% and 4% of patients (p: 0.077). Wound infection was present in 7%, 8% and 6% and suture dehiscence occurred in 2%, 2% and 3% of the patients in the three groups (no differences among them). Neither were differences found among the three groups in terms of urinary infections, pneumonia, postoperative ileus or intra-abdominal abscess.
                The addition of three doses of oral antibiotics to intravenous antibiotic prophylaxis is associated with lower patient tolerance in terms of increased nausea, vomiting and abdominal pain, and has shown no advantages in the prevention of postoperative septic complications. Therefore, we recommend that oral antibiotics should not be used prior to colorectal surgery. 101 patients with Clostridium-difficile-associated diarrhoea or colitis were prospectively randomised to 10-day oral courses of metronidazole, 250 mg four times a day, or vancomycin, 500 mg four times a day. 7 did not complete the protocol and were dropped from analysis. Pseudomembranous colitis (PMC) was diagnosed after endoscopy in 33 patients. Of the remaining patients without PMC, 38 had both C difficile culture and cytotoxin and 23 had only culture evidence of C difficile. 52 evaluable patients received vancomycin and 42 received metronidazole. There were two treatment failures with metronidazole and none with vancomycin (p = 0.20); and two relapses with metronidazole versus six with vancomycin (p = 0.17). Treatment in 1 patient in each group was discontinued because of drug intolerance. Response and relapse rates of the 33 patients with PMC were no different from those of the remaining patients. Pharmacy cost for the dosage used was $387.48 to $520.00 for vancomycin and $11.84 for metronidazole. Metronidazole and vancomycin have equivalent efficacy and relapse rates and are tolerated to a similar extent by patients with C-difficile-related diarrhoea and colitis, but metronidazole is considerably more economical. In a prospective randomized open study of patients operated upon for diffuse peritonitis, the effects of two different antibiotic regimens were evaluated. Cefuroxime given as a single drug (Group I; n = 59) was compared with a combination of cefuroxime and metronidazole (Group II; n = 63). Bacteriological cultures, both aerobic and anaerobic, were obtained peroperatively and in the event of any complication. The antibiotic sensitivities of isolated bacteria, and the serum and tissue concentrations of cefuroxime were determined. Postoperative infectious complications occurred in 22 per cent of Group I patients (cefuroxime), and in 17.5 per cent of Group II (cefuroxime plus metronidazole). The mortality rates were 5 per cent for Group I and 8 per cent for Group II. Tissue concentrations of cefuroxime were well above the MIC (minimal inhibiting concentration) values for most of the bacteria isolated. From a few patients in Group I, however, cultures were obtained with isolates sensitive to metronidazole but resistant to cefuroxime. Our findings suggest that, in the antibiotic treatment of patients operated for diffuse peritonitis, an agent which is primarily effective against aerobic bacteria (but not entirely without effect on anaerobes) is as effective as combination therapy covering both aerobic and anaerobic bacteria. The prophylactic effect of intraoperative "one shot" antibiotic application in colorectal surgery was investigated. Patients were randomised and the antibiotic combination Mezlocillin/Metronidazole (group A) or Amoxicillin/Clavulamid acid (group B) was applicated in 160 patients. 111 patients were selected for the study (group A: 59; group B: 52 patients). In the postoperative course 53% (group A) and 67% (group B) of the patients developed bacterial infections. Abdominal wound healing was complicated by infection in 15% (A) and 12% (B) of the patients. A significant difference between the two groups could not be proven, 24% of all patients with documented intraoperative bacterial contamination and 10% of the patients with negative findings developed wound infections. In colorectal surgery patients are still at high risk for infectious complications. Applicated antibiotics should basically cover aerobic and anaerobic germs. Toxin-producing Clostridium difficile is the commonest bacterial cause of nosocomial diarrhoea and is a well recognized cause of hospital outbreaks in elderly care units. High C. difficile disease rates have been associated with the use of broad-spectrum antibiotics, especially cephalosporins. An outbreak of C. difficile infection in the elderly care unit at Gloucestershire Royal NHS Trust continued despite increased ward cleaning and strict implementation of infection control measures. A restrictive antibiotic policy that would maintain colonization resistance in the gastrointestinal tract was introduced throughout this unit. Patients admitted with suspected infection were prescribed intravenous (i.v.) benzylpenicillin 1.2-1.8 g every 6 h to cover streptococcal infections and i.v. trimethoprim 200 mg twice daily to cover urinary tract pathogens and Haemophilus influenzae. If the patient had septic shock a single iv dose of gentamicin was given (120-180 mg) to cover more resistant gram-negative bacilli. The following were monitored before and after the policy change. The number of cases of C. difficile toxin-positive diarrhoea; cefuroxime and total antibiotic use on the elderly care wards; patient mortality rates; and length of hospital stay: two hundred and fifty-two and 234 patients respectively with a discharge diagnosis of infection were admitted before and after the antibiotic policy change. Mortality rates and length of hospital stay were unchanged. Cefuroxime prescribing and total antibiotic prescribing costs fell by 5150 pounds sterling and 8622 pounds sterling respectively in the 7 month period after the change. Thirty-seven cases of C. difficile diarrhoea occurred in the period before and 16 in the period after the policy change. The incidence of C. difficile diarrhoea and of cefuroxime use has remained low since then. The use of narrow-spectrum antibiotics for hospital treatment of community-acquired infections in the elderly should be encouraged. Outbreaks of C. difficile diarrhoea should be managed with the combined approach of infection control and strict antibiotic policies. It is now well demonstrated that a mixed flora of aerobic and anaerobic microorganisms will be found in wound abscesses and peritonitis after bowel surgery. An impressive reduction in infectious complications caused by anaerobic microorganisms can be achieved with nitroimidazole prophylaxis, but considerable uncertainty about the role of agents active against aerobic microorganisms in such prophylaxis still exists. We have earlier reported that a single dose of tinidazole and doxycycline significantly reduces postoperative infections and is superior to doxycycline alone. The effect of an agent active only against anaerobic microorganisms was tested in a double-blind study of 267 patients who underwent elective colorectal surgery. The patients received either tinidazole (1600 mg) and placebo or tinidazole (1600 mg) and doxycycline (400 mg) as a single preoperative infusion. Patients who received tinidazole and doxycycline had significantly fewer infectious complications, reoperations, additional use of antibiotics, and a shorter hospital stay. Microbiologic studies demonstrated that tinidazole alone gave effective protection against anaerobic organisms but did not protect the patients from aerobic gram-negative infectious complications. A single preoperative dose of antimicrobial agents effective against both anaerobic and aerobic bowel organisms seems to be the preferred prophylaxis for patients undergoing colorectal surgery. The incidence of Clostridium difficile-associated disease (CDAD) in hospitalised patients is increasing. Critically ill patients are often treated with antibiotics and are at a high risk of developing CDAD. Lactobacillus plantarum 299v (Lp299v) has been found to reduce recurrence of CDAD. We investigated intensive care unit (ICU) patients with respect to the impact of Lp299v on C. difficile colonisation and on gut permeability and parameters of inflammation and infection in that context.
                Twenty-two ICU patients were given a fermented oatmeal gruel containing Lp299v, and 22 received an equivalent product without the bacteria. Faecal samples for analyses of C. difficile and Lp299v were taken at inclusion and then twice a week during the ICU stay. Other cultures were performed on clinical indication. Infection and inflammation parameters were analysed daily. Gut permeability was assessed using a sugar probe technique.
                Colonisation with C. difficile was detected in 19% (4/21) of controls but in none of the Lp299v-treated patients (P<0.05).
                Enteral administration of the probiotic bacterium Lp299v to critically ill patients treated with antibiotics reduced colonisation with C. difficile. The impact of changes in antibiotic policy on Clostridium difficile-associated diarrhoea (CDAD), over a five-year period between 1995 and 2000, were studied in the Preston Acute Hospitals Trust. In 1996 the policy was changed in the Preston Acute Hospitals Trust from cefotaxime to ceftriaxone for initial treatment of severe sepsis or pneumonia in medical patients. Over the next nine months the average number of patients with C. difficile toxin-positive stools per quarter increased from 16 to 39. The predicted use of ceftriaxone exceeded by 65% an estimate based on prior use of cefotaxime. A policy of restricted duration of ceftriaxone was introduced, and although this reduced usage by over 50%, CDAD continued at an average of 9.2 cases per month, despite withdrawal of oral cephalosporins in December 1998. In August 1999 levofloxacin was substituted for ceftriaxone in the policy. The incidence of CDAD fell progressively to five cases per month by 2000. It would appear that a short (typically three dose) course of third-generation cephalosporin poses a similar risk for CDAD as a more prolonged course. The six-month delay in the decline of CDAD after virtual withdrawal of cephalosporins may reflect a slowly diminishing environmental reservoir. Elective laparoscopic cholecystectomy (LC) has a low risk for infective complications, but many surgeons still use prophylactic antibiotics. The use of prophylactic antibiotics for LC is inconsistent and varies widely among surgeons.
                We performed a prospective double-blind randomized study of prophylactic antibiotics in elective LC. Antibiotics were was given first before the operation and then again 24 h afterward. Group A ( n = 49) received 2 g of cefotaxime; group B ( n = 43) received 10 ml of isotonic sodium chloride solution. A sample of bile was withdrawn by direct gallbladder puncture for anaerobic and aerobic cultures. Age, sex, weight, duration of surgery (DOS), presence of diabetes mellitus, American Society of Anesthesiologists (ASA) classification, gallbladder rupture, bile and/or stone spillage, gallbladder histological findings, findings from bile cultures positive for bacteria, episodes of colic within 30 days before surgery, length of stay (LOS), and number of septic complications were recorded for both groups.
                There was no differences between the two groups in terms of sex, weight, DOS, ASA score, gallbladder rupture, bile and/or stone spillage, gallbladder histological findings, findings from bile cultures positive for bacteria, or LOS. One infection occurred in the antibiotic prophylaxis group (2.04%); in the patients not receiving antibiotics, there was one other infection (2.32%). There was no statistical difference between the two groups in infective complications.
                In patients undergoing elective LC, antibiotic prophylaxis is justified only in high-risk patients. In all other patients, antibiotic prophylaxis does not seem to affect the incidence of postoperative infective complications. In low-risk patients, eliminating the unnecessary use of prophylactic antibiotics would result in a cost reduction; moreover, it would lower the risk of adverse reaction and reduce microbial resistance. A prospective randomized single blind controlled clinical trial was undertaken to compare prophylactic therapy using a systemic antibiotic active against both aerobic and anaerobic bacteria with an oral antibiotic agent active only against anaerobic bacteria in elective colorectal surgery. One hundred and thirty-one patients received ticarcillin and 130 received tinidazole. The wound infection rate was 8% in those patients receiving ticarcillin prophylaxis and 20% in those receiving tinidazole (P less than 0.05). Multivariate analysis of the factors affecting wound infection rate showed that there were three independent factors that reached statistical significance: the prophylactic antibiotic used; the type of hospital (public or private) in which the operation was performed, and the presence of a stoma at operation. The wound infection rate in those patients receiving tinidazole prophylaxis was more than twice that reported previously by the authors. The mortality in patients receiving ticarcillin prophylaxis was 1.5% compared to 9.2% in those receiving tinidazole prophylaxis (P less than 0.05). The clinical anastomotic leakage rate was similar in each antibiotic prophylactic group, 8.6% in those receiving ticarcillin and 7.3% in those receiving tinidazole. Preoperative antibiotic prophylaxis is known to significantly reduce the incidence of postoperative wound infection in elective colorectal surgery, and is a recognized part of surgical management. Antibiotics are usually given systemically or orally, or by a combination of the two routes. Local antibiotic delivery to the wound site using an implanted, reabsorbable, gentamicin-containing collagen sponge is a novel concept. We compared postoperative wound infection rates in 221 colorectal surgery patients randomized to receive systemic gentamicin/metronidazole with (Group I, n = 107) or without (Group II, n = 114) the gentamicin-collagen sponge. The two patient groups were identical on the basis of demographics and operations undergone. The postoperative wound infection rate was significantly lower in Group I patients than Group II 5.6% (6/107) and 18.4% (21/ 114), respectively (p < 0.01). The mean duration of hospital stay was 13.8 days in Group I and 16.3 days in Group II, which did not represent a statistically significant difference. The gentamicin collagen sponge was well tolerated and no adverse events were reported that were attributable to its use. This new method for delivering gentamicin directly to the operative site may represent a significant method for reducing postoperative wound infection rates to levels lower than those currently achieved with systemic antibiotics alone. Antimicrobial treatment may disturb the colonization resistance of gastrointestinal microflora, which may induce clinical symptoms, most commonly diarrhea. The severity of antibiotic-associated diarrhea may range from a brief, self-limiting disease to devastating diarrhea with electrolyte disturbances, dehydration, crampy abdominal pain, pseudomembranous colitis, toxic megacolon, or even death. The incidence of diarrhea in children receiving a single antimicrobial treatment is unclear. In addition to more critical use of antimicrobials, adjunctive preventive measures to antibiotic-associated diarrhea are needed. The objective of this study was to evaluate the incidence of diarrhea after antimicrobial treatment in children with no history of antimicrobial use during the previous 3 months. Another aim of this study was to assess the preventive potential of Lactobacillus rhamnosus GG (Lactobacillus GG; American Type Culture Collection 53103), a probiotic strain with a documented safety record and a therapeutic effect in viral gastroenteritis on antibiotic-associated diarrhea.
                Oral antimicrobial agents were prescribed for the treatment of acute respiratory infections at the clinics of the Health Care Center of the City of Tampere or Tampere University Hospital, Finland, to 167 patients who were invited to participate in the study. Of the patients, 48 were lost to follow-up; therefore, the final study population consisted of 119 children from 2 weeks to 12. 8 years of age (mean: 4.5 years). All study subjects met the inclusion criteria: they had not received any antimicrobial medication during the previous 3 months, they did not suffer from gastrointestinal disorders, and they did not need intravenous antimicrobial treatment. The patients were randomized to receive placebo or 2 x 10(10) colony-forming units of Lactobacillus GG in capsules given twice daily during the antimicrobial treatment. Lactobacillus GG and placebo capsules were indistinguishable in appearance and taste. The parents kept a daily symptom diary and recorded stool frequency and consistency at home for 3 months. Diarrhea was defined as at least three watery or loose stools per day for a minimum of 2 consecutive days. In the case of diarrhea, viral (adenovirus, rotavirus, calicivirus and astrovirus) and bacterial (Salmonella, Shigella, Yersinia, Campylobacter, Clostridium difficile, Staphylococcus aureus, and yeasts) analyses were studied in fecal samples. The metabolic activity of the gut microflora was assessed by analysis of fecal urease, beta-glucosidase, and beta-glucuronidase activities. The primary outcome measure was diarrhea during the first 2 weeks after the beginning of the antimicrobial treatment, because this period most likely reflects the effects of antimicrobial use. Secondary outcome measures were the activities of fecal urease, beta-glucuronidase, and beta-glucosidase.
                On the entire follow-up, 80% of any gastrointestinal symptoms were reported during the first 2 weeks after the beginning of the antimicrobial treatment. The incidence of diarrhea was 5% in the Lactobacillus GG group and 16% in the placebo group within 2 weeks of antimicrobial therapy (chi(2) = 3.82). The treatment effect (95% confidence interval) of Lactobacillus GG was -11% (-21%-0%). In diarrheal episodes, the viral and bacterial analyses were positive for Clostridium difficile in 2 cases and for Norwalk-like calicivirus in 3 cases. The age of the patients with diarrhea was between 3 months and 5 years in 75% of cases in both groups. The severity of diarrhea was comparable in the study groups, as evidenced by similar stool frequency (mean: 5 per day; range: 3-6) and the duration of diarrhea (mean: 4 days; range: 2-8). The activities of fecal urease and beta-glucuronidase, but not beta-glucosidase, changed significantly after the beginning of the antimicrobial treatment in the Lactobacillus GG group and in the placebo group alike. (ABSTRACT TRUNCATED) The efficacy of vancomycin in pseudomembranous colitis was assessed in a prospective randomised controlled trial. Forty-four patients with postoperative diarrhoea were allocated to five days' treatment with either 125 mg vancomycin six-hourly or a placebo. Sixteen patients had high titres of the neutralised faecal toxin characteristic of pseudomembranous colitis; nine received vancomycin and seven placebo. At the end of treatment faecal toxins were present in one patient given vancomycin compared with five of the controls. Vancomycin caused the disappearance of Clostridum difficile from the stool in all except one patient, whereas toxicogenic strains of Cl difficile persisted in all but one of the controls. Histological evidence of psuedomembranous colitis had disappeared by the end of treatment in six out of seven patients given vancomycin compared with only one out of seven patients given vancomycin compared with only one out of five patients given placebo. In patients with faecal toxins bowel habit had returned to normal in seven of the vancomycin group compared with only one of the controls, but there was no significant difference in clinical response among patients without faecaal toxins. The results suggest that vancomycin eliminates toxin-producing Cl difficile from the colon and is associated with rapid clinical and histological improvement in patients with pseudomembranous colitis. Recurrent Clostridium difficile disease (CDD) is a difficult clinical problem because antibiotic therapy often does not prevent further recurrences. In a previous study, the biotherapeutic agent Saccharomyces boulardii was used in combination with standard antibiotics and was found to be effective in reducing subsequent recurrences of CDD. In an effort to further refine a standard regimen, we tested patients receiving a regimen of a standard antibiotic for 10 days and then added either S. boulardii (1 g/day for 28 days) or placebo. A significant decrease in recurrences was observed only in patients treated with high-dose vancomycin (2 g/day) and S. boulardii (16.7%), compared with those who received high-dose vancomycin and placebo (50%; P=.05). No serious adverse reactions were observed in these patients. Comparison of data from this trial with data from previous studies indicates that recurrent CDD may respond to a short course of high-dose vancomycin or to longer courses of low-dose vancomycin when either is combined with S. boulardii. Alatrofloxacin, the prodrug of trovafloxacin, is a novel fluoroquinolone antimicrobial agent with a broad spectrum, including activity against gram-positive and gram-negative aerobes and anaerobes. Its pharmacokinetic properties (long half-life, excellent tissue distribution, and good safety profile) suggest a role in surgical prophylaxis. This prospective, multicenter, double-blind trial compared alatrofloxacin with cefotetan, an approved drug for surgical prophylaxis, in reducing postoperative infections.
                The efficacy and safety of a single 200-mg intravenous dose of alatrofloxacin were compared to a single 2-g intravenous dose of cefotetan in 492 patients undergoing elective colorectal surgery. The efficacy of alatrofloxacin as a prophylaxis for wound, intra-abdominal, or remote-site postoperative infectious complications was compared with cefotetan in 317 clinically evaluable patients; 161 received alatrofloxacin and 156 received cefotetan. The patients were monitored for infections and safety for 30 days postoperatively.
                No statistically significant between-treatment difference was detected in successful clinical response rates at the end of the study (72% for each group). The incidence of primary wound infections at the time of hospital discharge was also similar: 21% in patients treated with alatrofloxacin and 18% in those treated with cefotetan. Safety, established by the incidence of adverse events, did not differ statistically between the groups.
                A single intravenous dose of alatrofloxacin given within 4 hours prior to surgery was as effective as an intravenous dose of cefotetan in the prevention of postoperative infectious complications in patients undergoing elective colorectal surgery. The safety profiles of the two medications were similar. A prospective, randomized, single-blind, controlled clinical trial was undertaken to compare two different prophylactic antibiotic regimens in patients undergoing elective colorectal surgery. Systemic Timentin, a combination of ticarcillin and the beta-lactamase inhibitor clavulanic acid, was assigned to 101 patients. Oral tinidazole, an agent active only against anaerobic bacteria, was assigned to 102 patients. The wound infection rate was 2.4 percent in the patients receiving Timentin and 14 percent in those receiving tinidazole (P = 0.01). Multivariate analysis of factors affecting the wound infection rate showed that the only factor that independently reached statistical significance was the prophylactic antibiotic used. The mortality of patients receiving Timentin prophylaxis was 3.4 percent compared with 8.9 percent of those receiving tinidazole (P = 0.15). The clinical anastomotic leakage rate was 1.3 percent in patients receiving Timentin and 13 percent in those receiving tinidazole (P = 0.01). These results, together with those of two previously published clinical trials by this group, indicate that antibiotic prophylaxis in elective colorectal surgery should consist of a short course of an agent effective against both aerobic and anaerobic bowel flora. In an open prospective, randomized study of antimicrobial prophylaxis in colorectal surgery, using a single intravenous dose, metronidazole (1 g) was more effective than doxycycline (0.2 g). The difference in infection rates (2/41 = 5% v. 7/33 = 21%) was statistically significant. Prolonged administration of either agent (2-7 days) yielded results comparable to those with single doses. Five emergency cases were admitted to the study. In two of them, a metronidazole-based therapeutic regimen prevented postoperative infection, whereas infection occurred in all 3 patients given doxycycline therapy. The total infection rate after elective surgery was 4% with metronidazole and 25% with doxycycline prophylaxis. The infections in the metronidazole group were superficial and caused by Escherichia coli, whereas half of the infections in the doxycycline group were intra-abdominal and due to intestinal aerobic and/or anaerobic bacteria. In contrast to doxycycline, therefore, metronidazole prevented postoperative anaerobic infection and was associated with low incidence of aerobic infection. The aim of this randomized double-blind study comparing the efficacy of two prophylactic regimens, metronidazole/placebo (n = 23) and metronidazole/fosfomycin (n = 26) was two-fold. First, to evaluate the need for anti-aerobic cover in addition to short-term systemic administration of metronidazole against anaerobes in colorectal surgery. Secondly, to explore the prophylactic effect of fosfomycin on aerobes of intestinal origin. An unacceptably high rate of surgical sepsis (16.3%) forced premature conclusion of the study after 49 patients had entered it. All surgical and remote infections occurred in the metronidazole/placebo group and were caused solely by aerobes. Anaerobic sepsis was not seen at all and the surgical infection rate was 34.8%. No septic complications occurred in the 26 patients (0%) receiving metronidazole/fosfomycin (p less than 0.01). Thus the study demonstrated both the need to administer an effective anti-aerobic agent in addition to metronidazole in colorectal surgery and the efficacy of fosfomycin in preventing aerobic sepsis of intestinal origin. Adverse reactions to the two drugs were not observed and resistance did not occur. 92 patients with antibiotic-associated diarrhea were randomized to receive oral teicoplanin 100 mg twice daily for 7 days (BID group); or 50 mg 4 times daily for 3 days, followed by 100 mg twice daily for 4 days (QID group) in a randomized, double-blind, multicentre study. Clostridium difficile was demonstrated by culture and/or cytotoxin test in 49 (53%) patients, of whom 47 (23 male, 24 females, mean age 65 years; 23 in the BID group, 24 in the QID group) were evaluable for clinical efficacy. Prior treatment with cephalosporins was registered in 49%, isoxazolyl-penicillins in 33% and clindamycin in 20% of the C. difficile positive patients. On the last day of treatment, 96% (23 of 24 patients) in the QID group were found cured, compared with 70% (16 of 23 patients) in the BID group (p = 0.02). On days 2 and 3 of treatment, QID group patients had significantly fewer loose stools per day (p < 0.05) than those of the BID group. Clinical recurrence, within 4 weeks post-treatment, occurred in 35% and 33% of the patients in the BID and QID groups, respectively. The bacteriological elimination rate 4 weeks post-treatment was 55% in the BID group and 59% in the QID group. The study was terminated prematurely due to the unexpectedly high clinical failure and recurrence rate in C. difficile positive patients treated with the BID dosage regimen. In a prospective, randomized double-blind study either 400 mg of doxycycline + 1500 mg of metronidazole (D + M) or 400 mg of doxycycline (D) alone were given intravenously as a single preoperative dose to patients admitted for elective colorectal surgery. A comparison of the rate of postoperative septic complications was made. After excluding drop-out patients, 261 patients remained for evaluation. In 135 patients with D + M treatment there were four postoperative septic complications (3.0%). In 126 patients with D treatment 20 septic complications related to the surgical procedure occurred (15.9%). The difference is highly significant (p less than 0.005). Most postoperative infections were superficial wound infections (14 of 24 patients), and the mean hospital stay in the two treatment groups was equal. Bacteriologic studies showed a highly significant reduction in anaerobes in cultures from perioperative intra-abdominal fluid in the D + M treatment group. The study has thus showed that the addition of metronidazole, an efficient agent against anaerobic bacteria, to an antimicrobial agent against aerobic bacteria significantly reduces postoperative septic complications in elective colorectal surgery. A prospective, randomized, double-blind and controlled clinical trial of systemic antibiotic prophylaxis with Cefazolin and Ornidazol (CO) versus Cefazolin and Placebo (CP) was carried out consecutively in 100 patients undergoing elective, colorectal surgery. The incidence of wound infection in the CP-group was 20% (n = 10) and in the CO-group 8% (n = 4) (p less than 0.10 ns). The reduction of anaerobic bacterias from 20% (n = 10) in the CP-group to 0% (n = 0) (CO) was significant (a1 = 0.0139; a2 = 0.0277 s, Fischer's exact test). The time of hospitalization was reduced from 20.3 days (CP) to 16.7 days (CO) (p less than 0.05 s). The agent for antibiotic prophylaxis in elective colorectal surgery is to cover the spectrum of anaerobic bacterias. Sixty assessable patients undergoing elective colonic and rectal surgery were randomly allocated to receive prophylaxis with a combination of 1.5 g cefuroxime plus 500 mg metronidazole or 500 mg metronidazole alone as single doses by the intravenous route, given at the beginning of anesthesia. The two groups were matched for age, sex, malignancy, and type of operation. Primary wound infections were observed in one patient (3.7%) in the combination group and six (18.2%) in the group given metronidazole alone. This trend was not statistically significant. Bacteriologic examination of the anastomoses, abdominal walls, and wounds showed significantly more sterile cultures in the combination group, although more aerobic cefuroxime-resistant isolates were seen in this group. There is no evidence that the emergence of resistant strains had any influence on the outcome of patients in the study. It was concluded that an appropriate antibiotic prophylactic regimen for colorectal surgery should be directed against aerobic and anaerobic organisms. Cefuroxime plus metronidazole is an effective regimen for the prevention of postoperative infection. A prospective, double-blind, randomized study was undertaken to compare perioperative parenteral metronidazole and erythromycin, One neomycin, and cefazolinhundred fifty-five patients were randomized into two groups by the pharmacy department. The resulting difference between the overall septic complication rate in patients receiving erythromycin, neomycin, and cefazolin (10.9 percent) and the rate in patients receiving metronidazole alone (31.9 percent) was significant. This indicates that an antibiotic to cover aerobic bacteria should be added to the regimen when metronidazole is used. The effectiveness of a ten-day course of either oral bacitracin or oral vancomycin hydrochloride for treatment of Clostridium difficile-induced antibiotic-associated diarrhea was compared in a randomized double-blind study. Bacitracin was as effective as vancomycin in resolving diarrhea; most patients responded within five days of therapy with either drug. Three patients receiving bacitracin worsened during therapy; two of these were considered treatment failures. Neither C difficile nor its toxin was detected in stool samples collected on the final day of therapy in 71% of patients (10/14) receiving vancomycin and in 30% (3/10) receiving bacitracin. Five patients receiving bacitracin and three receiving vancomycin had at least one recurrence. Low but nontoxic concentrations of bacitracin were detected in serum samples collected from 11 patients. Oral bacitracin at this dosage level was as effective as vancomycin in resolving the symptoms of C difficile-induced antibiotic-associated diarrhea in most patients but was less effective in eradicating C difficile and its toxin from patients' stools. Bacteriologic evidence suggests that Latamoxef (moxalactam) is effective against colonic bacteria which cause infection during colonic and rectal operations. In a prospective comparative study, 86 patients undergoing colorectal operations were randomized to receive intravenously 24 hour antibiotic cover with either gentamicin and metronidazole or moxalactam. Six patients (13 per cent) in the gentamicin and metronidazole group and five (12 per cent) in the moxalactam group had wound sepsis develop. Perineal wound sepsis (31 per cent) was significantly more common than abdominal wound sepsis (7 per cent). No complications were noted from the use of moxalactam. No clinical evidence of abnormal bleeding was seen and the results of studies on coagulation and platelet function postoperatively were normal. The results suggest that moxalactam provides effective, safe prophylaxis comparable with established antibiotic combinations in patients undergoing colorectal operations. OBJECTIVE: To study the effect of administration of clindamycin with or without supplementation of the intestinal microflora with Bifidobacterium bifidum and Lactobacillus acidophilus. METHODS: Twenty-three healthy subjects received clindamycin by mouth for 7 days. Eleven of the subjects also received capsules containing lyophilized L. acidophilus and B. bifidum for 14 days. The other 12 subjects received placebo. RESULTS: There was a marked decrease in total numbers of anaerobic bacteria during the administration of clindamycin. In the lactic acid bacteria-supplemented group, a tendency towards delayed reduction and earlier increase in bifidobacteria was observed, and two of 11 subjects (18%) were colonized with Clostridium difficile, in comparison with five of 12 (41%) in the placebo group. The total number of microorganisms was significantly higher in the lactic acid bacteria-supplemented group than in the placebo group (p=0.02) 4 days after the end of clindamycin administration. The difference was mainly due to higher counts of Escherichia coli and enterococci. Mean levels of other enterobacteria increased less in the lactic acid bacteria-supplemented group than in the placebo group between days 0 and 14. CONCLUSIONS: The recolonization with aerobic and anaerobic microorganisms was faster in the lactic acid bacteria-supplemented group than in the placebo group. This may be of importance in preventing colonization with C. difficile. The ideal prophylactic antibiotic regimen has not been established for patients undergoing colectomy, mucosal proctectomy, and endorectal ileoanal anastomosis, a prolonged operation frequently accompanied by abdominal and pelvic contamination and associated with an infection rate up to 20%. The aim of this study was to evaluate, in a prospective, randomized, double-blind fashion, the efficacy of a short perioperative course compared to an extended postoperative course of intravenous antibiotics (cefoxitin) in patients undergoing colectomy with ileoanal anastomosis. Forty patients with ulcerative colitis or familial polyposis coli received a mechanical and oral antibiotic bowel preparation and a standard three-dose perioperative course of intravenous cefoxitin. Patients then were randomized to receive intravenous cefoxitin, 1 g every 6 hours, or placebo for 5 days. No differences in overall postoperative morbidity were observed and neither group developed intra-abdominal, pelvic, or wound infections. It is concluded that a standard three-dose perioperative course of intravenous antibiotics provides adequate prophylaxis in the prevention of infectious complications in patients undergoing colectomy, mucosal proctectomy, and ileoanal anastomosis. OBJECTIVE--To determine the safety and efficacy of a new combination treatment for patients with Clostridium difficile-associated disease (CDD). The treatment combines the yeast Saccharomyces boulardii with an antibiotic (vancomycin hydrochloride or metronidazole). DESIGN--A double-blind, randomized, placebo-controlled, parallel-group intervention study in patients with active CDD. Patients received standard antibiotics and S boulardii or placebo for 4 weeks, and were followed up for an additional 4 weeks after therapy. Effectiveness was determined by comparing the recurrence of CDD in the two groups using multivariate analysis to control for other risk factors for CDD. SETTING--National referral study of ambulatory or hospitalized patients from three main study coordinating centers. PATIENTS--A total of 124 eligible consenting adult patients, including 64 who were enrolled with an initial episode of CDD, and 60 who had a history of at least one prior CDD episode. Patients who were immunosuppressed due to acquired immunodeficiency syndrome or cancer chemotherapy within 3 months were not eligible. INTERVENTION--Treatment with oral S boulardii (1 g/d for 4 weeks) or placebo in combination with a standard antibiotic. MAIN OUTCOME MEASURE--Recurrence of active CDD. RESULTS--A history of CDD episodes dramatically increased the likelihood of further recurrences. Multivariate analysis revealed that patients treated with S boulardii and standard antibiotics had a significantly lower relative risk (RR) of CDD recurrence (RR, 0.43; 95% confidence interval, 0.20 to 0.97) compared with placebo and standard antibiotics. The efficacy of S boulardii was significant (recurrence rate 34.6%, compared with 64.7% on placebo; P = .04) in patients with recurrent CDD, but not in patients with initial CDD (recurrence rate 19.3% compared with 24.2% on placebo; P = .86). There were no serious adverse reactions associated with S boulardii. CONCLUSIONS--The combination of standard antibiotics and S boulardii was shown to be an effective and safe therapy for these patients with recurrent CDD; no benefit of S boulardii was demonstrated for those with an initial episode of CDD. Systemic antibiotics given during the first week after tonsillectomy appear to be effective in reducing postoperative morbidity. We assessed the effectiveness of perioperative topical antibiotic rinses in reducing posttonsillectomy morbidity.
                A randomized, double-blinded, placebo-controlled pilot study of 36 patients undergoing tonsillectomy was used to evaluate the effects of a standard 7-day systemic regimen of perioperative intravenous ampicillin/oral amoxicillin and 2 single-day topical antibiotic regimens: (1) clindamycin (Cleocin) and (2) amoxicillin/clavulanate (Augmentin) and ticarcillin/clavulanate (Timentin).
                Mean aerobic and anaerobic oral bacterial counts were decreased in both topical treatment groups compared with the placebo group on the first postoperative day, achieving statistical significance with Augmentin/Timentin (aerobic and anaerobic bacterial counts) and Cleocin (aerobic counts). Significantly less postoperative pain and mouth odor were reported for both Cleocin (P = 0.014 and P = 0.005, respectively) and Augmentin/Timentin (P = 0.026 and P = 0.05, respectively) topical treatment groups when compared with the placebo group.
                Preliminary results indicate a reduction in oral bacterial counts and postoperative morbidity in adult patients receiving topical antibiotics compared with patients receiving placebo; further investigation is warranted. Two antibiotic regimens for the prophylaxis of infection after colorectal operations were compared in a prospective, double blind, randomised controlled trial in 244 patients. Ninety-five patients (39%) were either excluded before randomisation or withdrawn, leaving 149 for analysis. Group 1 (n = 72) received a single infusion of 8 g fosfomycin and 1 g metronidazole at the induction of anaesthesia. Group 2 (n = 77) received bacitracin 250 mg plus neomycin 250 mg (as four tablets on three occasions over two days), metronidazole 500 mg tablets three times a day for one day, and ampicillin 1 g intravenously at induction of anaesthesia. Nine patients in group 1 (13%), 95% confidence interval (CI) 6.9 to 22.4, developed infective complications, compared with 8 in group 2 (10%), 95% CI 4.6 to 19.4. The overall infection rate was 17 of 149 evaluable patients (11%), 95% CI 6.8 to 17.7. Seven patients died (five in group 1 and 2 in group 2), two of whom (one in each group) died as a direct result of infective complications. Long operations and obesity were the most important risk factors, and may indicate a need for longer prophylaxis. Fosfomycin, which is mainly active against aerobic bacteria, was both safe and useful when combined with metronidazole. In a prospective, randomized control trial, 152 consecutive patients requiring emergency or complicated colorectal surgery were allocated either to two doses of cefotetan or to five-day cover with gentamicin, and a single dose of metronidazole. Twenty-one patients received 6 gm of cefotetan before prolongation of prothrombin time dictated a change in the dose regimen such that all remaining patients (N = 55) received only 4 gm of cefotetan. The groups were well matched for diagnosis and surgical procedure. Rates of postoperative infection did not differ significantly between the groups, with wound infection rates occurring in 17 of 75 patients receiving gentamicin and metronidazole (22.7 percent) compared with ten of 75 receiving cefotetan (13 percent). Although wound infection rates were lower in the cefotetan group, the incidence of intra-abdominal abscess was similar in both groups. Eight patients receiving cefotetan developed intra-abdominal abscesses (11 percent), compared with seven receiving gentamicin and metronidazole (9 percent). Prolongation of prothrombin time in excess of 13 seconds occurred in six patients receiving cefotetan compared with no patients receiving gentamicin and metronidazole. None of these patients developed clinical bleeding, however. Ertapenem, a long-acting carbapenem, may be an alternative to the recommended prophylactic antibiotic cefotetan.
                In this randomized, double-blind trial, we assessed the efficacy and safety of antibiotic prophylaxis with ertapenem, as compared with cefotetan, in patients undergoing elective colorectal surgery. A successful outcome was defined as the absence of surgical-site infection, anastomotic leakage, or antibiotic use 4 weeks postoperatively. All adverse events were collected until 14 days after the administration of antibiotic prophylaxis.
                Of the 1002 patients randomly assigned to study groups, 901 (451 in the ertapenem group and 450 in the cefotetan group) qualified for the modified intention-to-treat analysis, and 672 (338 in the ertapenem group and 334 in the cefotetan group) were included in the per-protocol analysis. After adjustment for strata, in the modified intention-to-treat analysis, the rate of overall prophylactic failure was 40.2% in the ertapenem group and 50.9% in the cefotetan group (absolute difference, -10.7%; 95% confidence interval [CI], -17.1 to -4.2); in the per-protocol analysis, the failure rate was 28.0% in the ertapenem group and 42.8% in the cefotetan group (absolute difference, -14.8%; 95% CI, -21.9 to -7.5). Both analyses fulfilled statistical criteria for the superiority of ertapenem. In the modified intention-to-treat analysis, the most common reason for failure of prophylaxis in both groups was surgical-site infection: 17.1% in the ertapenem group and 26.2% in the cefotetan group (absolute difference, -9.1; 95% CI, -14.4 to -3.7). In the treated population, the overall incidence of Clostridium difficile infection was 1.7% in the ertapenem group and 0.6% in the cefotetan group (P=0.22).
                Ertapenem is more effective than cefotetan in the prevention of surgical-site infection in patients undergoing elective colorectal surgery but may be associated with an increase in C. difficile infection. (ClinicalTrials.gov number, NCT00090272 [ClinicalTrials.gov].).
                Copyright 2006 Massachusetts Medical Society. A randomized controlled trial was designed to compare antibiotic prophylaxis with a standard combination of agents, metronidazole and gentamicin, with a single preparation, amoxycillin/clavulanate in 400 patients undergoing elective colorectal surgery. There were 41 patients who were excluded or withdrawn (wrong dose, inappropriate operation, established sepsis or concurrent disease). Abdominal wound sepsis occurred in 14% of the assessable patients in the amoxycillin/clavulanate group and in 15% of the metronidazole plus gentamicin group. Perineal sepsis occurred in 27% of the amoxycillin/clavulanate group with a perineal wound compared with 18% in the metronidazole plus gentamicin group. Intra-abdominal abscess occurred in 8% of those who received amoxycillin/clavulanate compared with 6% of those given metronidazole plus gentamicin. Only two patients in each group developed septicaemia. Postoperative diarrhoea occurred in 11 patients receiving amoxycillin/clavulanate compared with four given metronidazole plus gentamicin. Clostridium difficile was not isolated from the stool cultures in any of these cases. Thirteen of the 164 abdominal or perineal wounds were infected by 15 strains of Bacteroides spp. in the group receiving amoxycillin/clavulanate compared with only three of the 165 wounds in those given metronidazole plus gentamicin. (P less than 0.01). There was no other significant difference in the pattern of isolates between the groups. This article describes a prospective study of the effectiveness of prophylactic antibiotic treatment in preventing infection following mastoid surgery. Seventy-two patients who underwent surgery for chronic middle ear disease served as the basis for this study. Bacteriologic findings from middle ear discharge, showing aerobic and anaerobic bacteria, are reported. The patients were randomly classified into two groups, one undergoing surgery with preventive antibiotic treatment with clindamycin and gentamycin and the other undergoing surgery without antibiotic therapy. The early postoperative inflammatory complications are presented. No significant differences were found in the incidence of these complications between the two groups. In view of the results, the effectiveness of preventive antibiotic treatment in mastoid surgery is questioned. A prospective randomized trial was designed to establish whether parenteral antibiotic prophylaxis was as effective as oral antimicrobial bowel preparation in preventing sepsis after colorectal surgery. Patients scheduled for elective resection of colorectal cancer received metronidazole and kanamycin either orally in the preoperative phase or parenterally as a short-term perioperative prophylaxis. The former regimen resulted in reduction of the microbial concentrations in the bowel contents in the absence of therapeutic serum concentrations at the time of operation, whereas the latter achieved therapeutic intraoperative serum levels without altering the colonic microflora. 72 patients were studied. There was no significant difference in the occurrence of postoperative sepsis between the two groups (a total of 72 patients). These results differ from those obtained at the Birmingham General Hospital using the same protocol, in which postoperative sepsis was significantly more common in the group of patients having oral bowel preparation. This difference was most probably due to an overgrowth of kanamycin-resistant coliforms during the period of oral antibiotic preparation. The presence of resistant organisms did not, however, result in failure of systemic prophylaxis. The authors conclude that short-term parenteral application is the safer method of antibiotic prophylaxis in colorectal surgery and is to be preferred to oral antimicrobial bowel preparation. A total of 169 patients undergoing colorectal surgery were randomly allocated to receive either gentamicin plus metronidazole or oral ciprofloxacin plus metronidazole as prophylaxis; they were also allocated to receive cover for 1 or 3 days. Twenty-eight patients (17 per cent) developed postoperative wound infections. The proportion of patients with wound infections and other infective complications was significantly less (P < 0.02) in those receiving oral ciprofloxacin. Cover for 3 days was no better than that for only 1 day. Oral ciprofloxacin for prophylaxis may offer advantages in efficacy and ease of administration compared with parenteral antibiotics. To determine the efficacy of a probiotic drink containing Lactobacillus for the prevention of any diarrhoea associated with antibiotic use and that caused by Clostridium difficile.
                Randomised double blind placebo controlled study.
                135 hospital patients (mean age 74) taking antibiotics. Exclusions included diarrhoea on admission, bowel pathology that could result in diarrhoea, antibiotic use in the previous four weeks, severe illness, immunosuppression, bowel surgery, artificial heart valves, and history of rheumatic heart disease or infective endocarditis.
                Consumption of a 100 g (97 ml) drink containing Lactobacillus casei, L bulgaricus, and Streptococcus thermophilus twice a day during a course of antibiotics and for one week after the course finished. The placebo group received a longlife sterile milkshake.
                Primary outcome: occurrence of antibiotic associated diarrhoea. Secondary outcome: presence of C difficile toxin and diarrhoea.
                7/57 (12%) of the probiotic group developed diarrhoea associated with antibiotic use compared with 19/56 (34%) in the placebo group (P=0.007). Logistic regression to control for other factors gave an odds ratio 0.25 (95% confidence interval 0.07 to 0.85) for use of the probiotic, with low albumin and sodium also increasing the risk of diarrhoea. The absolute risk reduction was 21.6% (6.6% to 36.6%), and the number needed to treat was 5 (3 to 15). No one in the probiotic group and 9/53 (17%) in the placebo group had diarrhoea caused by C difficile (P=0.001). The absolute risk reduction was 17% (7% to 27%), and the number needed to treat was 6 (4 to 14).
                Consumption of a probiotic drink containing L casei, L bulgaricus, and S thermophilus can reduce the incidence of antibiotic associated diarrhoea and C difficile associated diarrhoea. This has the potential to decrease morbidity, healthcare costs, and mortality if used routinely in patients aged over 50.
                National Research Register N0016106821. Cefoxitin, a second-generation cephalosporin, was compared with cefazolin, a first-generation cephalosporin, and a placebo in a prospective, double-blind study of antibiotic prophylaxis in women undergoing nonelective cesarean section. In the groups that received cefazolin or the placebo there eas no statistically significant change in colonization of the cervix by aerobic bacteria by the fourth day after the operation, but there was a statistically significant increase in colonization by anaerobes. Cefoxitin had the opposite effect. Of the 14 postoperative infections in 11 patients, significantly more were in patients who had received the placebo; the numbers were too small to show a difference in effectiveness between the two antibiotics. Of the microorganisms implicated as the infectious agents, group B Streptococcus was the most frequent aerobe, and Peptostreptococcus and Bacteroides bivius were the most frequent anaerobes. Among the 15 patients for whom at least one perioperative specimen yielded positive culture results, a postoperative infection developed in 5 of the 6 who received the placebo, 2 of the 4 who received cefazolin and 1 of the 5 who received cefoxitin. Ninety patients were included in this prospective randomized trial. Each required electric colorectal surgery and was prepared for operation with oral preoperative antibiotic therapy, systemic peroperative therapy, or by a combination of both. The number of each type of septic postoperative complication and their total did not differ between the group treated by oral antibiotics prior to operation and the group treated peroperatively with systemic antibiotic therapy. The total number of septic complications (wall abscesses, fistulas, subdiaphragmatic abscesses, septicemia, peritonitis), however, was significantly less (P less than 0.05) in the group treated by both preoperative oral antibiotics and peroperative systemic antibiotic therapy (3.3 per cent) than in either groups treated only orally preoperatively (30 per cent) or by systemic antibiotic therapy during the operation (23 per cent). The combination of oral antibiotic therapy prior to operation and of systemic peroperative antibiotic therapy, therefore, presents the most effective prophylactic effectiveness. To establish whether a single preoperative dose of cefotaxime plus metronidazole was as effective as a standard three dose regimen of cefuroxime plus metronidazole in preventing wound infection after colorectal surgery.
                Prospective randomised allocation to one of two prophylactic antibiotic regimens in a parallel group trial. Group sequential analyses of each 250 patients were performed.
                14 District general and teaching hospitals.
                1018 Adults having colorectal operations were randomised, of whom 943 were evaluated. Demographic features, conditions requiring surgery, and operative procedures were similar in the two groups. Most patients had surgery for carcinoma of the colon or rectum.
                Group 1 received cefotaxime 1 g intravenously plus metronidazole 500 mg intravenously preoperatively. Group 2 received cefuroxime 1.5 g intravenously plus metronidazole 500 mg intravenously preoperatively, followed by cefuroxime 750 mg intravenously plus metronidazole 500 mg intravenously eight hours and 16 hours postoperatively.
                Development of surgical wound infection (as evidenced by the presence of pus), death, or discharge from hospital.
                Wound condition was scored on a five point scale on alternate days until discharge or for up to 20 days postoperatively. Wound infection rates were: group 1, 32/453 (7.1%; 95% confidence interval 4.7% to 9.4%); group 2, 33/454 (7.3%; 95% confidence interval 4.9% to 9.6%). Death rates (group 1: 26/470 (5.5%); group 2: 31/471 (6.6%], the incidence of postoperative complications, the median duration of hospital stay (12 days), and antibiotic tolerance were all similar in the two groups. Pooled data from groups 1 and 2 showed that wound infections were more frequent when minor faecal contamination had occurred at operation and when the duration of operation exceeded 90 minutes (greater than 90 min 11.2% of cases; less than 90 min 4.8%) and were associated with an extended hospital stay.
                A single preoperative dose of cefotaxime plus metronidazole is an efficacious as a three dose regimen of cefuroxime plus metronidazole in preventing wound infection after colorectal surgery and has practical advantages in eliminating the need for postoperative antibiotics. Co-treatment with Saccharomyces boulardii appears to lower the risk of antibiotic-associated diarrhoea in adults receiving broad-spectrum antibiotics.
                To determine whether S. boulardii prevents antibiotic-associated diarrhoea in children.
                A total of 269 children (aged 6 months to 14 years) with otitis media and/or respiratory tract infections were enrolled in a double-blind, randomized placebo-controlled trial in which they received standard antibiotic treatment plus 250 mg of S. boulardii (experimental group, n = 132) or a placebo (control group, n = 137) orally twice daily for the duration of antibiotic treatment. Analyses were based on allocated treatment and included data from 246 children.
                Patients receiving S. boulardii had a lower prevalence of diarrhoea (> or =3 loose or watery stools/day for > or =48 h occurring during or up to 2 weeks after the antibiotic therapy) than those receiving placebo [nine of 119 (8%) vs. 29 of 127 (23%), relative risk: 0.3, 95% confidence interval: 0.2-0.7]. S. boulardii also reduced the risk of antibiotic-associated diarrhoea (diarrhoea caused by Clostridium difficile or otherwise unexplained diarrhoea) compared with placebo [four of 119 (3.4%) vs. 22 of 127 (17.3%), relative risk: 0.2; 95% confidence interval: 0.07-0.5]. No adverse events were observed.
                This is the first randomized-controlled trial evidence that S. boulardii effectively reduces the risk of antibiotic-associated diarrhoea in children. Diarrhoea is a common side effect of antibiotic therapy, especially in the elderly. Saccharomyces boulardii is a non-pathogenic yeast which has been demonstrated to reduce the frequency of diarrhoea in patients due to a variety of causes. We set out to assess its role in preventing antibiotic-related diarrhoea. Consecutive patients over the age of 65 admitted to medical wards, and who were being prescribed antibiotics, were randomized to receive either S. boulardii 113 g twice daily or placebo for as long as they received antibiotics. Bowel habit was monitored using a record of interdefaecatory intervals (IDI) and stool form graded 1-4 (hard to liquid). Stool samples were tested every fourth day for Clostridium difficile toxin. Of the 72 patients randomized, 69 completed the study. There was no difference in sex, age, duration of antibiotic use, length of hospital stay, IDI, stool form, the proportion of patients receiving laxatives, the number of patients experiencing watery stools (seven vs. five), or the presence of C. difficile toxin (five vs. three). No side effects were attributable to S. boulardii. There was no evidence that the concomitant use of S. boulardii with antibiotics alters patients' bowel habits or prevents the appearance of C. difficile toxin in the stool. Thus, S. boulardii cannot be recommended as a 'natural' way to prevent antibiotic-related diarrhoea. This highlights the need for proper evaluation of probiotics before their unrestricted use in medical practice. In the last 2 years, 50 patients who underwent elective colorectal surgery were prospectively studied about antibiotic prophylaxis. Two groups of 25 patients each were randomly selected. Both received: (a) a colic preparation: hypactic drugs and two enemas during the day before surgery and (b) metronidazole 0.5 g plus neomycin 1 g per 8 h orally for 1 day before surgery. Every group also received: group A, metronidazole 0.5 g plus amikacin 500 mg i.v. 2 h before surgery and the same doses per 8 or 12 h, respectively, for 2 days postoperatively; group B, ornidazole 1 g by intravenous infusion plus ceftriaxone 2 g i.v. 2 h before surgery and the same doses of the drugs per 24 h for 2 days postoperatively. Wound infection occurred in 1 case of group A versus 2 cases of group B (p greater than 0.25). Ornidazole plus ceftriaxone prophylactic antibiotic therapy is therefore as effective as a classic therapy (metronidazole plus amikacin) and constitutes an alternative choice for patients undergoing elective colorectal surgery, because the simple manner of its administration (once per 24 h) is resulting in cost saving due to gained nursing time. In a prospective randomized study meropenem was compared with imipenem/cilastatin in the treatment of 62 patients with intraabdominal infections requiring surgery. The patients were suffering from diffuse or local peritonitis of moderate severity complicating in most cases gangrenous appendicitis, stomach perforation or gallbladder disease. There were 30 patients in the meropenem group and 32 patients in the imipenem/cilastatin group. Both antibiotic regimens were given intravenously at a dosage of 1 g every 8 h for a mean duration of 7.7 days in the meropenem group versus 8.6 days in the imipenem/cilastatin group. Fifty-nine aerobic strains and 15 anaerobic strains were isolated from cultures of pus taken intraoperatively, the meropenem MICs ranging from < or = 0.25 to 2 micrograms/ml. At follow-up at least one month after treatment the outcome was considered successful in all of 27 evaluable patients given meropenem and in all of 29 evaluable patients given imipenem/cilastatin. Both antibiotic regimens were well tolerated. To compare the efficacy of combined oral and systemic antibiotics (combined) versus systemic antibiotics (systemic) alone in preventing surgical site infection in elective surgery of the colon, and to perform a meta-analysis of randomized studies comparing combined versus systemic antibiotics in elective colon surgery.
                A double-blind, placebo-controlled, randomized clinical trial.
                The Queen Elizabeth Hospital, Montreal, a university-affiliated community hospital.
                Two hundred and fifteen patients scheduled to undergo elective surgery of the colon.
                Patients were randomized to receive neomycin and metronidazole orally (109 patients) or identical placebos (106 patients) on the final preoperative day. All were given amikacin and metronidazole intravenously just before operation. Thirteen randomized series comparing combined and systemic antibiotic prophylaxis in elective colon surgery were identified for meta-analysis.
                Rates of postoperative surgical site infections: risk differences, risk ratios (RRs) and 95% confidence intervals (CIs); organisms found in the colon and wound fat at surgery, and in infected wounds.
                Three patients in the systemic group, and 5 in the combined group were excluded. Wound infections occurred in 5 patients in the combined group but in 17 in the systemic group (p < 0.01, RR = 0.29, 95% CI 0.11-0.75). Bacteria isolated from wound infections and wound fat were similar to those found in the colon. They were more frequent in the colon in the systemic group (p < 0.001) and occurred in wound fat in the systemic group twice as often as in the combined group (p < 0.001). By stepwise logistic regression, the presence of bacteria in wound fat at surgery was the strongest predictor of postoperative wound infection (p < 0.002). In the meta-analysis, the summary weighted risk difference in surgical site infections between groups (d(w)) and the summary RR both favoured combined prophylaxis (d(w) = 0.56, 95% CI 0.26-0.86; RR = 0.51, 95% CI 0.24-0.78; p < 0.001).
                In elective surgery of the colon combined oral and systemic antibiotics are superior to systemic antibiotics in preventing surgical site infections. Orally administered antibiotics add value by reducing bacterial loading of the colon and wound fat contamination, both associated with postoperative wound infection. Meta-analysis of randomized clinical trials reported from 1975 to 1995 supports these conclusions. An analytical framework is suggested for the economic evaluation of policies to improve the management of hospital infection. Consideration of the costs and benefits to be expected from improved policies implies the existence of an optimal infection rate which is higher than the minimum attainable. It follows that hospitals can and probably do spend too much on infection control in, at least, some areas. This optimal approach is not operational at present but its data requirements might be thought of as an agenda for future research. In the meantime, progress in infection control economics depends on a piecemeal approach. An example is given in the estimation of the cost savings attributable to an improved antibiotic prescribing policy at the Royal Liverpool Hospital. In an open, prospective, and randomized investigation on the prophylactic efficacy of peroral neomycin sulfate-erythromycin base vs intravenous ceftriaxone-metronidazole preparation in colorectal surgery, no significantly diverging results between regimens were recorded (1/27 [3.7%] and 2/27 [7.4%] wound infections, respectively). Commentary is made about the diverging results from earlier studies on antimicrobial prophylaxis and on the multifactorial causality of surgical infection. We believe that variables such as physical condition of the patients, virulence and local resistance patterns of bacteria, and technical skill of the surgeons are far more important in regard to the postoperative outcome concerning septic complications than is the choice of proper antibiotics. Thus, to determine the efficacy of antimicrobial prophylaxis, we call for larger investigations in the future, preferably double-blind, where it is possible to better control and diminish the influence of determinants other than the antibiotics being compared. Intraoperative fluid therapy regimens using oesophageal Doppler monitoring (ODM) to optimize stroke volume (SV) (goal-directed fluid therapy, GDT) have been associated with a reduction in length of stay (LOS) and complication rates after major surgery. We hypothesized that intraoperative GDT would reduce the time to surgical readiness for discharge (RfD) of patients having major elective colorectal surgery but that this effect might be less marked in aerobically fit patients.
                In this double-blinded controlled trial, 179 patients undergoing major open or laparoscopic colorectal surgery were characterized as aerobically 'fit' (n=123) or 'unfit' (n=56) on the basis of their performance during a cardiopulmonary exercise test. Within these fitness strata, patients were randomized to receive a standard fluid regimen with or without ODM-guided intraoperative GDT.
                GDT patients received an average of 1360 ml of additional intraoperative colloid. The mean cardiac index and SV at skin closure were significantly higher in the GDT group than in controls. Times to RfD and LOS were longer in GDT than control patients but did not reach statistical significance (median 6.8 vs 4.9 days, P=0.09, and median 8.8 vs 6.7 days, P=0.09, respectively). Fit GDT patients had an increased RfD (median 7.0 vs 4.7 days; P=0.01) and LOS (median 8.8 vs 6.0 days; P=0.01) compared with controls.
                Intraoperative SV optimization conferred no additional benefit over standard fluid therapy. In an aerobically fit subgroup of patients, GDT was associated with detrimental effects on the primary outcome.
                UK NIHR CRN 7285, ISRCTN 14680495. http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=7285. To report the investigation and effective control of a nosocomial epidemic of Clostridium difficile-associated diarrhea.
                Concurrent surveillance for identification of new nosocomial cases, retrospective case-control analysis, and hospital formulary control of antibiotic use.
                University-affiliated Veterans Affairs Medical Center located in southwestern United States.
                Hospitalized patients who developed diarrhea submitted stool specimens for cytotoxin assay. Patients who were positive for cytotoxin were compared with control patients without infection.
                Isolates of C. difficile were typed by restriction endonuclease analysis. Antimicrobial agent use from hospital pharmacy records and selected patient data from chart review were correlated with frequency of specific laboratory abnormalities.
                For 13 months, the monthly incidence of C. difficile infection averaged more than five times that for the previous 21 months. Stool specimens from 34 patients (59%) contained a single strain (restriction enzyme analysis type J7). Clindamycin was statistically associated with the epidemic as shown by the following: clindamycin use at our center compared with national normal values, clindamycin use for years before compared with during the epidemic, monthly use of clindamycin compared with monthly frequency of infection, frequency of infection in patients receiving clindamycin compared with that in patients receiving other antimicrobial agents, and amount of clindamycin used by infected patients compared with that used by control patients. Restricting clindamycin use led to a prompt disease in infection rate and the type J7 organisms.
                A nosocomial epidemic of C. difficile diarrhea was controlled by analysis of antibiotic use patterns and by subsequent restriction of clindamycin. The controversy over the route of administration of antibiotic prophylaxis in patients undergoing elective colorectal operations persists for oral, parenteral, and a combination of the two routes. The oral antibiotics commonly administered for colorectal prophylaxis, neomycin and eythromycin base, are not absorbed in the gastrointestinal tract (GIT). However, the 4-fluoroquinolones are absorbed in the upper GIT and are excreted in part by the colonic mucosa. Their action is then to remove, or severely depress, the gram-negative aerobic bacilli leaving the anaerobic flora unaffected. This action is the principle of selective decontamination. We have assessed the efficacy of oral ciprofloxacin in a prospective randomized clinical trial in which all patients received piperacillin 4 g i.v. as single-dose parenteral prophylaxis. A group of 327 evaluable patients were randomized to receive ciprofloxacin 500 mg b.i.d. with the preoperative cathartic (group OA, n = 159) or no oral antibiotic (group NOA, n = 168). Postoperative wound infection occurred in 18 (11.3%) patients in group OA and 39 (23.2%) patients in group NOA (chi 2 = 7.2, p = 0.007). Operation-related infection of any type occurred in 23 (14.5%) patients in group OA compared with 55 (32.7%) in group NOA (chi 2 = 14.0, p = 0.0002). The median postoperative hospital stay was 11 days (interquartile range 4.5 days) for group OA and 12 days (interquartile range 8 days) for group NOA (Mann Whitney U test, p = 0.005). Ignoring the treatment group, the median postoperative hospital stay was 17 days (interquartile range 10 days) for infected patients and 11 days (interquartile range 4 days) for those not infected.(ABSTRACT TRUNCATED AT 250 WORDS) Standard therapies for antibiotic-associated diarrhea (AAD) and Clostridium difficile-associated diarrhea (CDAD) have limited efficacy. Probiotic prophylaxis is a promising alternative for reduction of AAD and CDAD incidence.
                In this single-center, randomized, double-blind, placebo-controlled dose-ranging study, we randomized 255 adult inpatients to one of three groups: two probiotic capsules per day (Pro-2, n=86), one probiotic capsule and one placebo capsule per day (Pro-1, n=85), or two placebo capsules per day (n=84). Each probiotic capsule contained 50 billion c.f.u. of live organisms (Lactobacillus acidophilus CL1285 +Lactobacillus casei LBC80R Bio-K+ CL1285). Probiotic prophylaxis began within 36 h of initial antibiotic administration, continued for 5 days after the last antibiotic dose, and patients were followed for an additional 21 days.
                Pro-2 (15.5%) had a lower AAD incidence vs. Pro-1 (28.2%). Each probiotic group had a lower AAD incidence vs. placebo (44.1%). In patients who acquired AAD, Pro-2 (2.8 days) and Pro-1 (4.1 days) had shorter symptom duration vs. placebo (6.4 days). Similarly, Pro-2 (1.2%) had a lower CDAD incidence vs. Pro-1 (9.4%). Each treatment group had a lower CDAD incidence vs. placebo (23.8%). Gastrointestinal symptoms were less common in the treatment groups vs. placebo and in Pro-2 vs. Pro-1.
                The proprietary probiotic blend used in this study was well tolerated and effective for reducing risk of AAD and, in particular, CDAD in hospitalized patients on antibiotics. A dose-ranging effect was shown with 100 billion c.f.u., yielding superior outcomes and fewer gastrointestinal events compared to 50 billion c.f.u. (ClinicalTrials.gov number NCT00958308). The impact on wound infection of the addition of perioperative cefamandole to a mechanical bowel preparation with oral antibiotics was studied in a prospective randomized series of patients undergoing elective colectomy for biopsy-proven carcinoma or adenomatous polyps. Seventy patients were randomized, all underwent mechanical bowel preparation and received oral neomycin and erythromycin base. Thirty-four patients also received a preoperative and four postoperative doses of cefamandole, while 36 patients were randomized to receive no parenteral antibiotics. The two groups were well stratified for age, sex, and risk factors. The Dukes stage was similar and the surgical procedures were equally distributed in the two groups. There were no wound infections in the 34 patients receiving cefamandole and only one wound infection (2.8 percent) in the 36 control patients. Therefore, the addition of perioperative intravenous cefamandole to a good mechanical bowel preparation with oral antibiotics was of no benefit in reducing wound infections following resection of colorectal malignancies in this select group of patients. Bowel preparation prior to colonic surgery usually includes antibiotic therapy together with mechanical bowel preparation (MBP). Mechanical bowel preparation may cause discomfort to the patient, prolonged hospitalization, and water and electrolyte imbalance. It was assumed that with the improvement in surgical technique together with the use of more effective prophylactic antibiotics, it was possible that MBP would no longer be necessary.
                There is no statistical difference in the postoperative results of patients who undergo elective colon resection with MBP as compared with those who have no MBP. Design and
                The study includes all patients who had elective large bowel resection at Campus Golda between April 1, 1999, and March 31, 2002. Emergency operations were not included. The patients were randomly assigned to the 2 study groups (with or without MBP) according to identification numbers. All patients were treated with intravenous and oral antibiotics prior to surgery. The patients in the MBP group received Soffodex for bowel preparation.
                A total of 329 patients participated in the study, 165 without MBP and 164 with MBP. The 2 groups were similar in age, sex, and type of surgical procedure. Two hundred sixty-eight patients (81.5%) underwent surgery owing to colorectal cancer and 61 patients (18.5%) owing to benign disease. The hospitalization period was longer in the bowel-prepared group (mean +/- SD, 8.2 +/- 5.1 days) as compared with the nonprepared group (mean +/- SD, 8.0 +/- 2.7 days). However, this difference was not statistically significant. The time until the first bowel movement was similar between the 2 groups: a mean +/- SD of 4.2 +/- 1.3 days in the nonprepared group as compared with a mean +/- SD of 4.3 +/- 1.1 days in the prepared group (P = NS). Four patients (1.2%) died in the postoperative course owing to acute myocardial infarction and pulmonary embolism. Sixty-two patients (37.6%) of the non-MBP group suffered from postoperative complications as compared with 77 patients (46.9%) of the MBP group.
                Our results suggest that no advantage is gained by preoperative MBP in elective colorectal surgery. The aim of this study was to see if antibiotic pastilles could reduce radiation mucositis, pain, dysphagia and weight loss in patients undergoing radical radiotherapy for head and neck cancer. A total of 275 patients with T1-T4 tumours entered the study; 136 were allocated to suck four times daily a pastille containing amphotericin, polymyxin and tobramycin. The remaining 139 patients received an identical placebo. In all, 54 patients were unevaluable (24 active, 30 placebo). Bacteriological monitoring was carried out before and twice weekly during treatment. Both arms of the study were well balanced for T and N stage, age, sex and radiation dose (60 Gy). There was a slight imbalance in the site of disease which had no substantive effect on the results. The primary study end point was the percentage of patients who developed intermediate or thick pseudomembranes. No statistically significant difference was found in this end point, with 36% of patients in the active arm developing this type of membrane compared with 48% in the placebo arm (P = 0.118). The estimated odds ratio (placebo/active) of developing an intermediate or thick pseudomembrane was 1.59 (95% CI 0.89-2.82). However a more sensitive test comparing the worst recorded mucositis grade between the two arms was statistically significant (P = 0.009). This indicated that the active pastilles had a beneficial effect, but the magnitude was probably smaller than the trial was designed to detect. There was a reduction in mucositis distribution (P = 0.002), mucositis area (P = 0.028), dysphagia (P = 0.006) and weight loss (P = 0.009) in the active arm. There was a clear tendency for patients with positive cultures for aerobic Gram-negative bacteria (AGNB) (P = 0.003) and yeasts (P = 0.026) during treatment to have more severe mucositis. The active pastilles reduced the percentage of patients with yeast cultures (P = 0.003) but had less effect on AGNB. The benefit derived from the pastilles should materially increase patient tolerance to radical radiotherapy for head and neck cancer. Widespread antibiotic use has been associated with increases in both bacterial resistance and nosocomial infection.
                To characterize the impact of hospital-wide clindamycin restriction on the incidence of Clostridium difficile-associated diarrhea and on antimicrobial prescribing practices.
                Prospective, observational cohort study.
                University-affiliated Veterans Affairs Medical Center.
                Hospitalized patients with symptomatic diarrhea.
                Clinical data on individual patients and data on antibiotic use were obtained from hospital pharmacy records. Hospital-wide use of antimicrobial agents was monitored. Isolates of C. difficile underwent antimicrobial susceptibility testing and molecular typing.
                An outbreak of C. difficile-associated diarrhea was caused by a clonal isolate of clindamycin-resistant C. difficile and was associated with increased use of clindamycin. Hospital-wide requirement of approval by an infectious disease consultant of clindamycin use led to an overall reduction in clindamycin use, a sustained reduction in the mean number of cases of C. difficile-associated diarrhea (11.5 cases/month compared with 3.33 cases/month; P < 0.001), and an increase in clindamycin susceptibility among C. difficile isolates (9% compared with 61%; P < 0.001). A parallel increase was noted in the use of and costs associated with other antibiotics with antianaerobic activity, including cefotetan, ticarcillin-clavulanate, and imipenem-cilastin. The hospital realized overall cost savings as a result of the decreased incidence of C. difficile-associated diarrhea.
                Hospital formulary restriction of clindamycin is an effective way to decrease the number of infections due to C. difficile. It can also lead to a return in clindamycin susceptibility among isolates and can effect cost savings to the hospital. A randomized double-blind placebo-controlled comparison of prophylactic cefoxitin, an antibiotic with good activity against anaerobic bacteria, with cefazolin, an agent effective predominantly against aerobes, was undertaken in 354 women who underwent nonelective cesarean section (124 receiving cefoxitin, 119 cefazolin, and 111 placebo). Among the placebo group, 24.3% developed genital tract-related infection, in comparison to 5.6% of the cefoxitin patients and 6.7% of the cefazolin patients (P less than 0.001). Standard febrile morbidity, fever index, and duration of postoperative hospital stay were also significantly less in the antibiotic prophylactic groups. For patients with febrile morbidity, the mean fever index was less in the cefoxitin group (24.8 degree-hours) than that in the cefazolin group (42.7 degree-hours), and this difference approached statistical significance (P less than 0.1, greater than 0.05). Postoperative hospital stay longer than 1 week for infectious morbidity occurred in 26% of cefoxitin patients, a significantly lower incidence compared to the 66% rate for patients who received cefazolin, and the 57% incidence for patients in the placebo group (P less than 0.05). A randomized trial including 294 patients was performed to evaluate the prophylactic effect of single vs. multiple doses of antibiotics in elective colorectal surgery. All patients received 1.5 g metronidazole and 3.0 g ampicillin peroperatively and were randomized to: no further prophylactic antibiotic treatment, or ampicillin 1 g X 3 and metronidazole 0.5 g X 3 given intravenously during the second and third postoperative days. Deep wound infection was seen in 9/149 (6 percent) receiving a single dose and in 8/145 (6 percent) receiving multiple doses. No differences were found in the two groups between frequencies of anastomotic dehiscences, intra-abdominal abscesses, sepsis, and pulmonary infections. The two groups were similar according to distribution of sex, age, diagnosis, and type of surgery. A single peroperative dose of metronidazole and ampicillin is a simple and satisfactory antibiotic prophylaxis in elective colorectal surgery. Clostridium difficile colitis has increased in incidence and severity, and treatment failure with metronidazole therapy has increasingly been documented. It is uncertain whether treatment with vancomycin is more effective than treatment with metronidazole, but concern over the emergence of vancomycin resistance has motivated the search for alternative therapy. Nitazoxanide, a nitrothiazolide, blocks anaerobic metabolism of eukaryocyes and effectively treats intestinal infestation due to Cryptosporidium or Giardia species. At low concentrations, this compound inhibits C. difficile in vitro.
                We designed a prospective, randomized, double-blind study to compare nitazoxanide to metronidazole in treating hospitalized patients with C. difficile colitis.
                Thirty-four patients received metronidazole at a dosage of 250 mg 4 times per day for 10 days, 40 patients received nitazoxanide at a dosage of 500 mg 2 times per day for 7 days, and 36 patients received nitazoxanide at a dosage of 500 mg 2 times per day for 10 days. After 7 days of treatment, 28 (82.4%) of 34 patients had responded to metronidazole therapy, compared with 68 (89.5%) of 76 who had received nitazoxanide therapy (difference, 7.1%; 95% confidence interval, -7.1% to 25.5%). Thirty-one days after beginning treatment, sustained responses were observed in 19 (57.6%) of 33 patients who had received metronidazole therapy for 10 days, compared with 25 (65.8%) of 38 who had received nitazoxanide for 7 days and 26 (74.3%) of 35 who had received nitazoxanide for 10 days (P = .34).
                Nitazoxanide is at least as effective as metronidazole in treating C. difficile colitis. To estimate and compare the frequencies of inflammatory complications after third molar (M3) surgery in subjects receiving intravenous prophylactic antibiotics or saline placebo.
                Using a placebo-controlled, double-blind, randomized clinical trial, the investigators enrolled a sample composed of subjects who required extraction of at least 1 impacted M3 and requested intravenous sedation or general anesthesia. The predictor variable was treatment group classified as active treatment (penicillin or clindamycin for penicillin-allergic subjects) or placebo (0.9% saline). Study medications were randomly assigned. Both surgeon and subject were blinded to treatment assignment. The medication was administered intravenously prior to any incision. The outcome variable was postoperative inflammatory complication classified as present or absent and included alveolar osteitis (AO) or surgical site infection (SSI). Other variables were demographic, anatomic, or operative. Descriptive and bivariate statistics were computed. Statistical significance was set at P < or = .05, single-tailed test of hypothesis.
                The sample was composed of 118 subjects (n = 59 per study group). In the active treatment group, there were no postoperative inflammatory complications. In the placebo group, 5 subjects (8.5%) were diagnosed with SSI, (P = .03). No subject met the case definition for AO. All SSIs were associated with the removal of partial bony or full bony impacted mandibular M3s.
                In the setting of third molar removal, these results suggest that the use of intravenous antibiotics administered prophylactically decrease the frequency of SSIs. The authors cannot comment on the efficacy of intravenous antibiotics in comparison to other antibacterial treatment regimens, eg chlorhexidine mouthrinse or intrasocket antibiotics. A randomized prospective study was conducted on 194 patients who underwent elective colorectal surgery for carcinoma. All patients received the same mechanical bowel preparation. In addition, patients in group A received oral neomycin and erythromycin base; patients in group B received systemic metronidazole and gentamicin, while patients in group C received both oral and systemic antibiotics. Postoperative septic complications related to colorectal surgery occurred in 27.4 per cent, 11.9 per cent and 12.3 per cent respectively in groups A, B and C (chi 2 = 7; P less than 0.05). The incidence of sepsis in groups B and C was almost identical. Patients who received oral antibiotics alone (group A) had significantly higher risks of postoperative sepsis when compared with patients in either group B or group C (P less than 0.05). As there is no additional advantage of combining oral and systemic antibiotics, we recommend systemic metronidazole and gentamicin to be used with mechanical bowel preparation in elective colorectal surgery. Pre-operative preparation of the colon is carried out with oral and/or intravenous administration of antibiotics and through the mechanical preparation of the colon using various substances to decrease the intraluminal bacterial concentration and remove the larger quantity of fecal material as possible, thus decreasing the risk of anastomosis dehiscence due to an increase in the intraluminal pressure. The role of antibiotics has been completely established while that of mechanical preparation is still questioned. The objective of this study is to assess the actual impact of mechanical preparation on colorectal surgery.
                Forty seven patients who underwent elective colorectal surgery were prospectively evaluated, out of which only 24 had mechanical preparation. We compared variables such as age, sex, preoperative hemoglobin, albumin and leukocyte values, surgery characteristics and type of anastomosis, as well as complications in both groups. Results: We found a higher incidence of fistulas, dehiscences and general complications in the group undergoing mechanical preparation of the colon.
                The results show that mechanical preparation of the colon does not provide any benefit and may result in a higher incidence of complications in colorectal surgery. To evaluate the role of Lactobacillus rhamnosus GG (LGG) as probiotic in persistent diarrhea (PD) in children of North Bengal, India.
                Hospital-based study.
                Randomized, double-blind controlled trial.
                All patients of PD admitted over a period of 2 years were included in the study as per predefined inclusion criteria. They were randomized to receive oral rehydration solution (ORS) alone, or ORS plus LGG powder containing 60 million cells, twice daily for a minimum period of 7 days or till diarrhea has stopped along with correction of dehydration with ORS and/or intravenous fluids as per WHO protocol and antibiotics in culture positive patients. The duration and frequency of purge and vomiting were studied. Data were analyzed by SPSS-10 software. Statistical significance was calculated by Student t test and chi2 test.
                The study comprised of 235 patients randomized into 2 groups, cases (117) and controls (118). Both the groups were similar with respect to age, number of breastfed infants, presentation with dehydration, degree of protein energy malnutrition, and distribution of infections. Stool culture was positive in 90 (38.3%) patients, Escherichia coli being the commonest organism followed by Shigella spp. and Clostridium difficile. The mean duration of diarrhea was significantly lower in the cases than in controls (5.3 vs. 9.2 d). The average duration of hospital stay was also significantly lesser in cases. No complication was observed from the dose of LGG used.
                LGG (dose of 60 million cells) could decrease the frequency and duration of diarrhea and vomiting and reduced hospital stay in patients of PD. Convincing evidence that probiotic administration can lower the risk of antibiotic-associated diarrhoea is limited to certain micro-organisms.
                To determine the efficacy of administration of Lactobacillus rhamnosus (strains E/N, Oxy and Pen) for the prevention of antibiotic-associated diarrhoea in children.
                Children (aged 3 months to 14 years) with common infections were enrolled in a double-blind, randomized, placebo-controlled trial in which they received standard antibiotic treatment plus 2 x 10(10) colony forming units of a probiotic (n = 120) or a placebo (n = 120), administered orally twice daily throughout antibiotic treatment. Analyses were by intention to treat.
                Any diarrhoea (>or=3 loose or watery stools/day for >or=48 h occurring during or up to 2 weeks after the antibiotic therapy) occurred in nine (7.5%) patients in the probiotic group and in 20 (17%) patients in the placebo group (relative risk, RR 0.45, 95% confidence interval, CI 0.2-0.9). Three (2.5%) children in the probiotic group developed AAD (diarrhoea caused by Clostridium difficile or otherwise unexplained diarrhoea) compared to nine (7.5%) in the placebo group (RR 0.33, 95% CI 0.1-1.06). No adverse events were observed.
                Administration of L. rhamnosus (strains E/N, Oxy and Pen) to children receiving antibiotics reduced the risk of any diarrhoea, as defined in this study. The effect of an 8-hour, 3-dose perioperative regimen of cefazolin or placebo was evaluated in 97 patients. Postoperative morbidity occurred in 13 patients (27.1%) in the cefazolin group and in 17 patients (34.7%) who received placebo. The clinical sites of infection were similar in both groups except that wound infections (2) and sepsis (2) were found only in patients receiving placebo. Aerobic organisms diminished and anaerobes increased in patients who received antibiotics. Aerobic isolates were essentially unchanged and fewer anaerobes were recovered from patients given placebo. Antibiotic levels observed at cesarean section were in the therapeutic range. The only risk factor which correlated with morbidity was the presence of ruptured membranes. This short course, single drug regimen did not significantly reduce morbidity although it was bacteriologically effective. Two hundred and twenty-nine patients were entered into a study to compare the effectiveness and safety of two single-shot antibiotic regimes in patients undergoing elective colorectal surgery in two district general hospitals. A single shot of intravenous (IV) latamoxef disodium was as effective as an IV combination of cefuroxime and metronidazole in control of wound infection following elective large bowel surgery when given as a bolus at the time of anaesthetic induction. The incidence of major wound infection was 6% and was evenly distributed in the two treatment groups. Half the major wound infections were associated with faecal fistulae. A single shot of IV antibiotic at the time of anaesthetic induction was safe, simple and an effective prophylaxis against major wound infection. There was a low incidence (1.3%) of serious postoperative bleeding and no serious adverse reactions were noted. The overall mortality was 9%. Death was significantly related to elderly patients, a poor performance status, operative contamination and wound infections. Our purpose was to determine whether the incidence of postoperative endometritis and wound infection is associated with the method of placental removal at the time of cesarean section.
                Parturients undergoing cesarean delivery were prospectively randomized to have the placenta removed manually or spontaneously. Patients were excluded from participation if they had received intrapartum prophylactic antibiotics or had been determined to have chorioamnionitis. After delivery of the infant women in the manual group had the placenta extracted by the primary surgeon, whereas women in the spontaneous group had the placenta delivered by gentle traction on the umbilical cord. All study subjects received perioperative prophylactic antibiotics. The primary outcome variable was a postcesarean infection, defined as postecsarean endometritis or wound cellulitis requiring drainage and antibiotic therapy.
                A total of 333 women were enrolled in the investigation, with 165 assigned to the manual removal group and 168 allocated to have spontaneous removal. There were no statistically significant differences in mean gestational age, frequency or duration of ruptured membranes, frequency or duration of labor, or mean number of vaginal examinations between the two study groups. Postoperative infections occurred in 25 of 168 (15%) women in the spontaneous delivery group compared with 44 of 165 (27%) women in which the placenta was manually extracted (relative risk 0.6, 95% confidence interval 0.4 to 0.9, p = 0.01). Subset analysis of patients delivered with ruptured membranes similarly demonstrated a statistically significant reduction in the incidence of postoperative infections with spontaneous placental removal compared with manual extraction (20% vs. 38%, relative risk 0.5, 95% confidence interval 0.3 to 0.9, p = 0.02). There was a similar trend toward a reduction in postdelivery infections associated with spontaneous placental removal in women with intact membranes; however, this difference did not attain statistical significance.
                Spontaneous delivery of the placenta after cesarean delivery is associated with a decrease in the incidence of postcesarean infections. To compare the effectiveness of cranberry extract with low-dose trimethoprim in the prevention of recurrent urinary tract infections (UTIs) in older women.
                One hundred and thirty-seven women with two or more antibiotic-treated UTIs in the previous 12 months were randomized to receive either 500 mg of cranberry extract or 100 mg of trimethoprim for 6 months.
                Thirty-nine of 137 participants (28%) had an antibiotic-treated UTI (25 in the cranberry group and 14 in the trimethoprim group); difference in proportions relative risk 1.616 (95% CI: 0.93, 2.79) P = 0.084. The time to first recurrence of UTI was not significantly different between the groups (P = 0.100). The median time to recurrence of UTI was 84.5 days for the cranberry group and 91 days for the trimethoprim group (U = 166, P = 0.479). There were 17/137 (12%) withdrawals from the study, 6/69 (9%) from the cranberry group and 11/68 (16%) from the trimethoprim group (P = 0.205), with a relative risk of withdrawal from the cranberry group of 0.54 (95% CI: 0.19, 1.37).
                Trimethoprim had a very limited advantage over cranberry extract in the prevention of recurrent UTIs in older women and had more adverse effects. Our findings will allow older women with recurrent UTIs to weigh up with their clinicians the inherent attractions of a cheap, natural product like cranberry extract whose use does not carry the risk of antimicrobial resistance or super-infection with Clostridium difficile or fungi. In a multicenter study the prophylactic efficacy of two antibiotic regimens was tested against postoperative septic complications following elective colorectal surgery. The study was conducted in a prospective block-randomized design. Patients were preoperatively allocated to either ampicillin, 1 gm, four times daily, and metronidazole, 0.5 gm, three times daily, for 72 hours, or to cefoxitin, 2 gm, given three times in a period of 10 hours. Both regimens were initiated immediately before surgery. Forty-five patients were withdrawn from the study after randomization. Three hundred fifty two patients (175 receiving ampicillin and metronidazole and 177 receiving cefoxitin) completed the study and were followed for one month postoperatively. The frequency of septic and nonseptic complications was not statistically significant different between the two regimens. About one third of all septic complications appeared more than two weeks after surgery. It is concluded that short-term treatment with cefoxitin is at least as efficient as a three-day treatment with ampicillin and metronidazole. In a randomized prospective trial of prophylactic antibiotics in at-risk abdominal surgery, one dose of intravenous Augmentin (amoxycillin 250 mg and clavulanic acid 125 mg) on induction has been compared with three 8 hourly doses in 900 patients. Wound infection rates which included minor and delayed infections were very similar in those given one dose: 48/449 (10.7%) compared with those given three doses: 49/451 (10.9%) 95% confidence limits - 4.25% + 3.9%. There were more septic and sepsis-related deaths in those patients given one dose (14 deaths) than in those given three doses (7 deaths) P > 0.1 95% CL - 0.4% + 3.0%. However, there were more very elderly patients in the one dose group: 64% of the deaths were aged over 80 and all but one had an emergency operation. There was no difference in the other outcome measures studied which included non-fatal deep sepsis, length of postoperative hospital stay, duration of postoperative fever or the use of antibiotics for postoperative infection. One dose of a suitable intravenous antibiotic gives prophylaxis against wound infection in at-risk abdominal surgery which is at least as effective as multiple doses. However, there may be a risk of overwhelming systemic sepsis in very elderly patients having emergency surgery. A prospective, randomized double-blind study was undertaken to compare the efficacy of three prophylactic regimens (oral neomycin and erythromycin, intravenous cefoxitin, and a combination of both oral and intravenous antibiotics) in patients undergoing elective colorectal surgery. One hundred sixty-nine patients were randomized and 146 patients were evaluable. Septic complications occurred in 11.4 per cent of patients receiving oral antibiotics only, in 11.7 per cent of patients receiving intravenous cefoxitin alone, and in 7.8 per cent of patients receiving both oral and intravenous antibiotics. These differences were not statistically different. The greatest number of septic complications occurred in those patients with anastomotic disruptions. Two patients died (1.3%), both of whom had major anastomotic failures. There was no advantage between any of the groups in the incidence of wound infection (3.9-6.8%). Thus, no advantage could be identified in this study in the combination of oral and intravenous antibiotics in elective colorectal surgery. Prophylactic metronidazole was compared with no treatment in a randomly allocated study of patients undergoing appendicectomy. A 1-g suppository of metronidazole was given with the premedication and 200 mg t.d.s. orally for 7 days thereafter. There were 4 hospital wound infections in the 87 patients receiving metronidazole and 11 out of 83 in the no-treatment group (P < 0.05). However, 60 per cent of wound infections occurred at home and the overall infection rates were not significantly different. The duration of postoperative hospital stay was longer in the control group (5.8 days +/- 3.0 s.d.) than in the treated group (4.8 +/- 2.3; P < 0.01). Only one anaerobic infection occurred in a patient receiving metronidazole but late infection was not prevented. Blood levels of metronidazole taken at the end of operation showed a wide variation but there was no correlation with subsequent infection. Culture of the appendix showed aerobic organisms in 88 per cent of cases and anaerobes in 72 per cent. It is suggested that an antibiotic which is effective against both aerobic and anaerobic organisms might have an advantage over metronidazole in appendicitis. There are two critical moments for the development of severe infectious complications following transurethral prostatectomy (TURP): the operative and immediate postoperative periods, and the day that the postoperative drainage catheter is removed. To optimize the timing of antibiotic prophylaxis with cefotaxime, two prospective randomized studies were conducted in patients with preoperatively sterile urine. In Study 1, all patients (n = 50) received cefotaxime 1 g intramuscular (i.m.) 1 hour preoperatively and were then randomized to receive either a second identical dose of cefotaxime 1 hour before catheter removal 24 hours later, or no further antibiotic treatment. In Study 2, patients (n = 89) were randomized to receive either cefotaxime 1 g i.m. 1 hour preoperatively or no preoperative antibiotic, after which all received cefotaxime 1 g i.m. 1 hour before catheter removal. Results were compared using identical evaluation criteria for infection in both studies: incidence of fever (temperature > 38 degrees C), bacteriuria (10(5) organisms/mL) and positive blood cultures, and duration of hospital stay (days). In Study 1, infection was significantly reduced with respect to all parameters in the group receiving two doses of cefotaxime, and total drug treatment costs were halved. In Study 2, the groups did not differ with respect to any parameter. We conclude that a single dose of cefotaxime 1 g i.m. 1 hour preoperatively provides inadequate cover for urethral catheter removal 24 hours later, and that prophylaxis with a single dose of cefotaxime 1 g i.m. 1 hour before catheter removal is just as effective as two doses given 1 hour preoperatively and 1 hour before catheter removal. Prophylactic coverage is essential during the action of removing the catheter and the time immediately following the operation. Long-term antibiotic coverage (24 hours or more) is not necessary. Thus, following TURP in patients with preoperatively sterile urine undergoing continuous bladder irrigation for 24 hours postoperatively, the optimal dose schedule for antibiotic prophylaxis with cefotaxime is a single 1-g dose given i.m. 1 hour before catheter removal. The aim of this study was to compare aerobic and resistance training in children with cystic fibrosis (CF) admitted to hospital with an intercurrent pulmonary infection with a control group. The subjects were randomized into three groups on the first day of admission. The fat-free mass (FFM) was calculated, using the skin fold thickness from four sites (biceps, triceps, subscapular, and iliac crest). Pulmonary function tests were performed within 36 hr of admission and repeated on discharge from the hospital, and again at 1 month after discharge. All subjects performed an incremental treadmill exercise test, using a modified Bruce protocol. Lower limb strength was measured using a Cybex dynamometer. An assessment of quality of life was made using the Quality of Well Being Scale, as previously reported. Activity levels were measured using a 7-day activity diary, and subjects also wore an accelerometer on their hips. There were no significant differences between the three groups in terms of disease severity, and length of stay in hospital. Subjects in all three groups received intravenous antibiotics and nutritional supplementation as determined by the physician. Children randomized to the aerobic training group participated in aerobic activities for five sessions, each of 30-min duration, a week. The children randomized to the resistance training group exercised both upper and lower limbs against a graded resistance machine. Subjects in the control group received standard chest physiotherapy. Our study demonstrated that children who received aerobic training had significantly better peak aerobic capacity, activity levels, and quality of life than children who received the resistance training program. Children who received resistance training had better weight gain (total mass, as well as fat-free mass), lung function, and leg strength than children who received aerobic training. A combination of aerobic and resistance training may be the best training program, and future studies to assess optimal training programs for CF patients are indicated.
                Copyright 2002 Wiley-Liss, Inc. Previous research has suggested that cough associated with acute bronchitis is more likely to subside within 7 days when treated with albuterol than with an antibiotic. This study examines the effectiveness of aerosolized albuterol for the treatment of acute bronchitis in patients treated with erythromycin or placebo.
                A double-blind, randomized placebo-controlled trial of albuterol delivered by metered-dose inhaler (MDI) was conducted in a primary care setting with healthy adult patients who presented with a productive cough of fewer than 30 days' duration. In addition to randomization for albuterol, patients were also randomized to receive erythromycin or placebo. Outcomes were assessed at follow-up after 7 days.
                Patients treated with albuterol MDI were less likely to be coughing after 7 days of treatment than were patients using a placebo inhaler (61% still coughing vs 91%, P = .02). When analysis was stratified by cigarette smoking status and the use of erythromycin, the differences observed between albuterol MDI patients and controls persisted.
                Albuterol appears to reduce the likelihood that patients with acute bronchitis will be coughing after 7 days following initiation of treatment. This effect appears to be independent of cigarette smoking or the concomitant use of antibiotics. To ascertain whether therapeutic equivalence exists for the treatment of paediatric community acquired pneumonia by the oral and intravenous (IV) routes.
                A multicentre pragmatic randomised controlled non-blinded equivalence trial was undertaken in eight paediatric centres in England (district general and tertiary hospitals). Equivalence was defined as no more than a 20% difference between treatments of the proportion meeting the primary outcome measure at any time. 246 children who required admission to hospital and had fever, respiratory symptoms or signs and radiologically confirmed pneumonia were included in the study. Exclusion criteria were wheeze, oxygen saturations <85% in air, shock requiring >20 ml/kg fluid resuscitation, immunodeficiency, pleural effusion at presentation requiring drainage, chronic lung condition (excluding asthma), penicillin allergy and age <6 months. The patients were randomised to receive oral amoxicillin for 7 days (n = 126) or IV benzyl penicillin (n = 120). Children in the IV group were changed to oral amoxicillin after a median of six IV doses and received 7 days of antibiotics in total. The predefined primary outcome measure was time for the temperature to be <38 degrees C for 24 continuous hours and oxygen requirement to cease. Secondary outcomes were time in hospital, complications, duration of oxygen requirement and time to resolution of illness.
                Oral amoxicillin and IV benzyl penicillin were shown to be equivalent. Median time for temperature to settle was 1.3 days in both groups (p<0.001 for equivalence). Three children in the oral group were changed to IV antibiotics and seven children in the IV group were changed to different IV antibiotics. Median time to complete resolution of symptoms was 9 days in both groups.
                Oral amoxicillin is effective for most children admitted to hospital with pneumonia (all but those with the most severe disease who were excluded from this study). Prior to this study, the British Thoracic Society guidelines on childhood pneumonia could not draw on evidence to address this issue. This will spare children and their families the trauma and pain of cannulation, and children will spend less time in hospital. Patients undergoing cancer chemotherapy frequently suffer from mucositis, particularly if they become leukopenic (leucocytes <1000/microL). To identify a possible benefit from antiseptic rinsing of the oral cavity, 47 patients were randomized to rinse either with a chlorhexidine-based product (chlorhexidine concentration 0.3%; N=24) or with an amine-stannous fluoride combination (control group; N=23). Patients were asked to rinse three times a day for 30s from the beginning of chemotherapy until the end of leukopenia. Before rinsing, as well as during and after leukopenia, aerobic and anaerobic bacteria in the oral cavity were counted. At the same time, the patients were assessed for mucositis. In the chlorhexidine-based group, a significant decrease of the aerobic (P=0.042) and anaerobic (P=0.008) bacterial flora was identified. In the control group, the numbers of aerobic and anaerobic bacteria remained unchanged (P>0.05). Fifteen patients in the chlorhexidine-based group had a C-reactive protein (CRP) increase >50mg/L, compared with only eight patients in the control group [odds ratio: 3.13, confidence interval (CI) 0.82-12.39]. Nine patients in the chlorhexidine-based group but only two patients in the control group developed severe mucositis. This difference was statistically significant with an odds ratio of 6.30 (CI: 1.02-49.67). As not all of the 47 patients developed severe leukopenia, a separate analysis was carried out for patients with <1000 leucocytes/microL for a minimum of three days. The results of the microbial counts were very similar, with a clear reduction in the chlorhexidine group and no major alterations in the control group. Twelve of 15 patients in the chlorhexidine-based group had a CRP >50mg/L whereas only eight of 15 patients did so in the control group, which can be regarded as a slightly elevated risk for a CRP increase in the former group. Seven of 15 patients developed severe mucositis in the chlorhexidine-based group, but only two of 15 patients in the control group. These differences were not significant, but patients treated with chlorhexidine-based product seemed to have more problems with inflammation of the oral mucous membranes, resulting in an elevated mucositis score and a CRP increase. Other parameters such as body temperature or application of antibiotics did not differ between the two groups. We conclude that treatment with the chlorhexidine-based product did not provide a clinical benefit for cancer chemotherapy patients. On the contrary, the risk of mucositis and clinical sequelae seems to be enhanced, although the counts of micro-organisms on the oral mucous membranes are significantly reduced. Preoperative anxiety and physical unfitness have been shown to have adverse effects on recovery from cardiac surgery. This study involving cardiac surgery patients was primarily aimed at assessing the feasibility of delivering physical conditioning and stress reduction programs within the public hospital setting. Secondary aims were to evaluate the effect of these programs on quality of life (QOL), rates of postoperative atrial fibrillation (AF) and length of stay (LOS) in hospital.
                Elective patients scheduled for coronary artery bypass graft and/or valve surgery at a public hospital in Melbourne, Australia were enrolled. Patients were randomized to receive either holistic therapy (HT) or usual care (UC). HT consisted of a series of light physical exercise sessions together with a mental stress reduction program administered in an outpatient setting for the first two weeks after placement on the waiting list for surgery. A self-administered SF-36 questionnaire was used to measure QOL and hospital records to collect data on LOS and rate of postoperative AF.
                The study population comprised 117 patients of whom 60 received HT and 57 received UC. Both programs were able to be delivered within the hospital setting but ongoing therapy beyond the two week duration of the program was not carried out due to long waiting periods and insufficient resources. HT, as delivered in this study, compared to UC did not result in significant changes in QOL, LOS or AF incidence.
                Preoperative holistic therapy can be delivered in the hospital setting, although two weeks is insufficient to provide benefits beyond usual care on QOL, LOS or postoperative AF. Further research is now required to determine whether a similar program of longer duration, or targeted to high risk patients can provide measurable benefits.
                This trial was conducted as part of a larger study and according to the principles contained in the CONSORT statement 2001. A prospective randomized study was performed with 61 patients undergoing elective surgery for colorectal cancer, to evaluate the prophylactic effect of two different parenteral antibiotic regimens. All patients were randomly allocated into two groups, comparable in age, sex, nutritional status and operative procedures. The patients in Group A (n. 31) received 1 g i.v. of imipenem-cilastatin at induction of anesthesia. Patients in Group B (n. 30) were given cefuroxime (1.5 g i.v.) plus metronidazole (0.5 g i.v.) at the time of anesthesia and two other administrations of the combined antibiotics (cefuroxime 0.75 g plus metronidazole 0.5 g i.v.) every 8 hours. The severity of sepsis was evaluated according to the scoring system proposed by Elebute and Stoner. No significant differences were found in terms of the rate of surgical infections: 9% in Group A and 16% in Group B. Infections not of surgical origin were found only in Group B (10.4%). These data suggest that a single dose of intravenous imipenem-cilastatin appears to be as effective as three doses of cefuroxime and metronidazole as prophylaxis against infection in elective colorectal surgery. To evaluate the impact of an interventional multidisciplinary antibiotic management program on expenditures for antibiotics and on the incidence of nosocomial infections caused by Clostridium difficile and antibiotic-resistant pathogens during 7 years.
                Prospective study with comparison with preintervention trends.
                University-affiliated teaching hospital.
                All adult inpatients.
                A multidisciplinary antibiotic management program to minimize the inappropriate use of third-generation cephalosporins was implemented in 1991. Its impact was evaluated prospectively. The incidence of nosocomial C. difficile and resistant Enterobacteriaceae infections as well as the rate of vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA) were compared with those of National Nosocomial Infections Surveillance System hospitals of similar size.
                Following implementation of the program, there was a 22% decrease in the use of parenteral broad-spectrum antibiotics (P < .0001) despite a 15% increase in acuity of patient care during the following 7 years. Concomitantly, there was a significant (P = .002) decrease in nosocomial infections caused by C. difficile and a significant (P = .02) decrease in nosocomial infections caused by resistant Enterobacteriaceae. The program also appeared to have a favorable impact on VRE rates without a sustained impact on MRSA rates.
                These results suggest that an ongoing multidisciplinary antibiotic management program may have a sustained beneficial impact on both expenditures for antibiotics and the incidence of nosocomial infection by C. difficile and resistant bacterial pathogens. Prophylactic use of topical ampicillin in addition to intravenous ampicillin and metronidazole was studied in a randomized trial including 203 consecutive patients undergoing elective colorectal surgery. All received ampicillin, 1 g X 3, and metronidazole, 0.5 g X 3, intravenously for at least three days from induction of anesthesia, and 105 also received topical ampicillin, 1 g, in each of the surgical wounds. Deep wound infection or dehiscence was seen in 12 of 105 having both administrations of antibiotics, and in nine of 98 having only intravenous antibiotics. The two groups were similar according to distribution of sex, age, type of surgery, and efficiency of bowel preparation. Topical ampicillin should be omitted in elective colorectal surgery when systemic prophylaxis with ampicillin and metronidazole is used. Antibiotic overuse and resistance have become a major threat in the last 2 decades. Many programs tried to optimize antibiotic consumption in the inpatient setting, but the outpatient environment that represents the bulk of antibiotic use has been challenging. Following a significant rise of Clostridium difficile infections, all the health care stakeholders in the province of Quebec, Canada initiated a global education program targeting physicians and pharmacists.
                A bundle approach was used; 11 user-friendly guidelines were produced by a group of experts and sent to all physicians and pharmacists in Quebec in January 2005. Downloadable versions of guidelines were posted on a dedicated Web site. They were promoted by professional organizations, universities, and experts during educational events, and there was strong acceptance by the pharmaceutical industry with a willingness to follow the recommendations in their marketing. The Intercontinental Medical Statistics (IMS) database was used to analyze and compare Quebec's total outpatient prescriptions per 1000 inhabitants with those in the other Canadian provinces for 2 time periods: preintervention (January 2003 to December 2004), and postintervention (February 2005 to December 2007).
                In 2004, antibiotic consumption per capita was 23.3% higher in Canada generally than in Quebec. After the guidelines dissemination, the gap between Quebec and the other Canadian provinces increased by 4.1 prescriptions/1000 inhabitants (P = .0002), and the trend persisted 36 months later. Antibiotic costs fell $134.5/1000 inhabitants in Quebec compared with the rest of Canada (P = .054).
                The implementation of guidelines significantly reduced antibiotic prescriptions in Quebec compared with the rest of the country, and there was a strong trend toward significant cost reduction. A prospective randomized clinical trial was conducted to test the effectiveness of long-term and short-term prophylaxis with cefuroxime in preventing morbidity after cesarean section. Sixty patients who required emergency cesarean section were randomly assigned to one of three treatment groups: a control group of 20 patients receiving no prophylactic antibiotics; a group of 20 patients receiving 24 hours of cefuroxime prophylaxis (0.75 gm 30 to 60 minutes before surgery and at 8 hours and 16 hours after surgery); and a group of 20 patients receiving five days of cefuroxime prophylaxis (0.75 gm three times a day, the first dose being given postoperatively). The short-term and long-term prophylaxes were equally effective in reducing morbidity, assessed by postoperative temperatures, presence or absence of endometritis, and duration of postoperative hospital stay. Due to the high incidence of infective complications following colorectal surgery, prophylactic application of systemic antibiotics is required. In a prospective, randomised study of 34 patients who underwent elective colorectal surgery, it was found that a single 1 g dose of cefotaxime was as effective as three doses in controlling post-operative infections. Both groups received 500 mg metronidazole i.v. every 12 h for 72 h, with the first dose administered immediately prior to surgery. The results indicate that prophylactic cefotaxime and metronidazole are effective in reducing the incidence of septic complications following colorectal surgery; nevertheless, a study with a larger number of patients is needed to reach a definitive conclusion. To examine if intake of Lactobacillus plantarum can prevent gastrointestinal side effects in antibiotic-treated patients.
                Diarrhea is a common side effect of treatment with antibiotics. Some studies indicate that the risk of antibiotic-associated diarrhea can be reduced by administration of certain probiotic microorganisms.
                Patients treated for infections at a university hospital infectious diseases clinic were randomized to daily intake of either a fruit drink with L. plantarum 299v (10(10) colony forming units/d) or a placebo drink, until a week after termination of antibiotic treatment. Subjects recorded the number and consistency of stools as well as gastrointestinal symptoms until up to 3 weeks after last intake of test drink. Fecal samples were collected before the first intake of test drink and after termination of antibiotic therapy and analyzed for Clostridium difficile toxin.
                Clinical characteristics on admission were similar in the 2 groups. The overall risk of developing loose or watery stools was significantly lower among those receiving L. plantarum [odds ratio (OR), 0.69; 95% confidence interval (CI), 0.52-0.92; P=0.012], as was development of nausea (OR, 0.51; 95% CI, 0.30-0.85; P=0.0097). Diarrhea defined as > or =3 loose stools/24 h for > or =2 consecutive days was unaffected by the treatment (OR, 1.4; 95% CI, 0.33-6.0; P=0.86). No significant differences regarding carriage of toxin producing C. difficile were observed between the groups.
                Our results indicate that intake of L. plantarum could have a preventive effect on milder gastrointestinal symptoms during treatment with antibiotics. Reductions of frequency of administration and dosage of antibiotic agents used in colorectal surgery may lower costs and the occurrence of adverse side effects. In a prospective randomized trial we evaluated two single-short regimens, a low dose of 1 g cefotiam against a standard dose of 2 g cefotiam, both in combination with 500 mg metronidazole. The low-dose group had twice the number of patients with wound sepsis (4 of 30) than the group receiving the standard antibiotic regimen (2 of 30). Two hours after infusion, the antibiotic concentrations in samples of serum, subcutaneous fatty tissue, and colonic wall of those patients receiving 1 g cefotiam were < 1 mg/l. The concentrations after administration of 2 g cefotiam were higher, as expected, and without any adverse side effects. In conclusion, we prefer infection prophylaxis by the standard dose of 2 g cefotiam plus 500 mg metronidazole in colorectal surgery. Traditionally obstetric infections have been treated with combination antimicrobial agents that provide coverage against aerobic and anaerobic bacteria commonly found in these infections. New antibiotics may be a monotherapy alternative for this type of infections. The objective of the study was to compare the efficacy of the agent piperacillin/tazobactam against ampicillin plus gentamicin in the treatment of postcesarean endometritis. By randomized way 14 patients were enrolled in the piperacillin/tazobactam group and 42 in the ampicillin-gentamicin group. A favorable clinical response occurred in 78.6% of piperacillin/tazobactam patients and 88.1% of ampicillin and gentamicin patients (p = NS). There was no statistically significant difference in the times to recovery and days of hospitalization between the two groups. The combination piperacillin/tazobactam did not show advantage towards the standard treatment, so combination antimicrobial agent continue been the optimal approach to the management of obstetric infection. In a randomized study the clinical and bacteriologic effectiveness of imipenem was compared with the classical combination of netilmicin with clindamycin in patients who had surgery for an intraperitoneal infection, localized or generalized, with positive bacteriologic findings of the specimen taken at surgery. Excluded were all patients who received other antibiotics before surgery, or who died within 3 days after antibiotic therapy was started. Imipenem was given at a dose of 500 mg t.i.d., clindamycin 600 mg t.i.d., and netilmicin according to serum levels. The diagnoses ranged from postoperative peritonitis, gallbladder empyema, perforated gastroduodenal ulcer, small bowel perforation with and without obstruction, and perforated appendicitis to perforation of the colon. The bacteriologic work-up included examination of the primary specimen (aerobic and anaerobic), the urine, feces, and serologic testing for Candida albicans once or twice a week and after the course of antibiotic therapy. In addition, pH measurements of abscesses and drainage fluids were performed. Ninety-three patients entered the study. Forty-seven patients were treated with imipenem (test group), and 46 patients were treated with the combination therapy (control group). The two groups did not show significant differences in age, sex, diagnostic groups, risk factors, primary bacteriology, and duration of therapy (mean: 6.7 days). Thirty-eight patients (80.9%) treated with imipenem were cured, six patients (12.8%) were improved, and there were three (6.4%) failures. The respective numbers for the control group were 31 (67.4%), 10 (21.7%), and 5 (10.9%). The mean duration of hospitalization was 19 days for the test group and 24.5 days for the control group. There were four wound infections in the test group and 11 wound infections in the control group. Imipenem is at least as effective in the adjuvant therapy of intra-abdominal infections as the combination of netilmicin with clindamycin. The aim of the study was to test the hypothesis that aerobic Gram-negative bacteria (AGNB) play a crucial role in the pathogenesis of radiation-induced mucositis; consequently, selective elimination of these bacteria from the oral flora should result in a reduction of the mucositis.
                Head-and-neck cancer patients, when scheduled for treatment by external beam radiation therapy (EBRT), were randomized for prophylactic treatment with an oral paste containing either a placebo or a combination of the antibiotics polymyxin E, tobramycin, and amphotericin B (PTA group). Weekly, the objective and subjective mucositis scores and microbiologic counts of the oral flora were noted. The primary study endpoint was the mucositis grade after 3 weeks of EBRT.
                Seventy-seven patients were evaluable. No statistically significant difference for the objective and subjective mucositis scores was observed between the two study arms (p = 0.33). The percentage of patients with positive cultures of AGNB was significantly reduced in the PTA group (p = 0.01). However, complete eradication of AGNB was not achieved.
                Selective elimination of AGNB of the oral flora did not result in a reduction of radiation-induced mucositis and therefore does not support the hypothesis that these bacteria play a crucial role in the pathogenesis of mucositis. In 132 patients who underwent elective surgery of the colon, the value of bowel preparation with a conventional oral antibiotic preparation of neomycin-erythromycin (N-E) was compared with erythromycin-metronidazole (E-M). Of 125 patients who were available for assessment, 61 received N-E and 64 E-M. The two groups were evenly matched. Two wound infections occurred in patients receiving E-M, neither due to anaerobic bacteria, but seven wound infections developed in patients given N-E (p = 0.057), five of them caused by anaerobic bacteria. Anaerobic bacteria of the colon are the dominant cause of postoperative wound infection in elective surgery of the colon. Adequate antibiotic preparation directed against these bacteria makes the use of neomycin unnecessary. In a prospective randomized, blind trial, three groups of patients undergoing elective colonic surgery were compared for frequency of surgical wound infection, intra-operative wound contamination and other postoperative infections. All patients allotted to the three groups received whole gut irrigation (101 balanced salt solution) by gastric tube on the evening before surgery and were treated as follows. Group A: no antibiotics; Group B: neomycin (1 g/l) + bacitracin (50,000 IU/l) + clindamycin (900 mg/l), contained in the last 31 of irrigation fluid; Group C: mezlocillin (4 g) + oxacillin (2 g) intravenously (iv) at induction of anaesthesia, followed by two identical doses at 8 and 16 h. The rate of postoperative wound infection was highest in A (38 per cent) and much lower in B (3.3 per cent, P less than 0.002) and C (6.9 per cent, P less than 0.004). The difference between B and C was statistically not significant. In A a correlation was established between the degree of wound contamination and the occurrence of wound infection. Intra-operative wound contamination was lowest in B (30 per cent), equal in A (58.1 per cent) and B (55.2 per cent). Other infections were least frequent in group C (four of 29 patients), but were not significantly different to groups B (six of 30) and A (nine of 31). It is concluded that antibiotics together with an effective mechanical preparation considerably reduce the rate of wound infection in colonic surgery. The role of prophylactic antibiotics in otologic surgery continues to be debated and perhaps misused. Prior studies have provided conflicting evidence with regard to the benefit obtained from the use of prophylactic antibiotics in surgery for chronic otitis media. The current study was designed to evaluate the role of prophylactic antibiotics in the outcomes of surgery for chronic ear disease. It was the authors' impression that there was no indication for prophylactic antibiotics in such surgery.
                Randomized prospective study performed in a tertiary care facility.
                Patients who met inclusion criteria (n = 146) were randomly assigned to an antibiotic treatment group or a control group receiving no prophylactic antibiotics. Patients in the antibiotic treatment group were given preoperative intravenous antibiotics followed by oral antibiotics for 5 days after surgery. Patients were followed postoperatively and observed for clinical evidence of infection and graft failure.
                There was no statistically significant difference between the two groups with regard to the incidence of postoperative infection or graft survival.
                The use of prophylactic antibiotics in surgery for chronic ear disease cannot be recommended based on the findings of this study. To assess the effect of a tailored professional intervention, including academic detailing, on antibiotic prescribing for acute cough.
                In a cluster-randomized controlled before and after study 85 Flemish GPs included adult patients with acute cough consulting in the periods February-April 2000 and 2001. The intervention consisted of a clinical practice guideline for acute cough, an educational outreach visit and a postal reminder to support its implementation in January 2001. Antibiotic prescribing rates and patients' symptom resolution were the main outcome measures.
                Thirty-six of 42 GPs received the intervention and 35 of 43 GPs served as controls; 1503 patients were eligible for analysis. Only in the intervention group were patients less likely to receive antibiotics after the intervention [OR(adj) (95% CI)=0.56 (0.36-0.87)]. Prescribed antibiotics were also more in line with the guideline in the intervention group [1.90 (0.96-3.75)] and less expensive from the perspective of the National Sickness and Invalidity Insurance Institute [MD(adj) (95% CI)= Euro -6.89 [-11.77-(-2.02)]]. No significant differences were found between the groups for the time to symptom resolution.
                An (inter)actively delivered tailored intervention implementing a guideline for acute cough is successful in optimizing antibiotic prescribing without affecting patients' symptom resolution. Further research efforts should be devoted to cost-effectiveness studies of such interventions. In a prospective controlled trial, 750 patients undergoing elective biliary, gastric or colorectal surgery were randomized to receive short-term or long-term antibiotic prophylaxis--cefotaxime for biliary or gastric, and gentamicin/metronidazole for colorectal operations. In all patients, delayed cutaneous hypersensitivity was preoperatively assessed by simultaneous application of seven standardized recall antigens. Positive reaction was defined as mean diameter greater than or equal to 2 mm, anergy as no positive reaction to any antigen, and a 'score' as the sum (in mm) of all the mean diameters of positive reactions. There was no significant difference in septic complication or mortality rates following short-term vs. long-term prophylaxis. Anergy was found in 21 patients (2.8%), while 63 (8.4%) scored 2-4 and 666 (88.8%) greater than or equal to 5. The incidence of postoperative infectious complications was 25% in the patients with score less than 5 and 10% in those scoring greater than or equal to 5, and the corresponding mortality was 14.3 and 2.1% (both p less than 0.001). In the group with preoperative scores less than 5, the duration of antibiotic prophylaxis influenced neither postopertive infectious complications nor mortality. To evaluate the efficacy of prophylactic antibiotics for dental implant placement.
                Twelve Italian private practices agreed to participate in this trial, each centre providing 30 patients. One hour prior to implant placement, patients were randomised, for consumption orally of 2 g amoxicillin or identical placebo tablets. Patients needing bone augmentation procedures were not included. Outcome measures were prosthesis and implant failures, adverse events and post-operative biological complications. Patients were seen 1 week, 2 weeks and 4 months post-operatively.
                One centre did not deliver any data and 14 patients had to be excluded from the trial for various reasons. One hundred and fifty-eight patients were evaluated in each group and none dropped out at 4 months. Two prostheses and two implants failed in the antibiotics group, compared with four prostheses and nine implants in the placebo group. There were no statistically significant differences for prosthesis failures, implant losses, complications and side effects.
                No statistically significant differences were observed. However, four times more patients in the placebo group experienced implant failures than in the antibiotic group, and this requires further investigation. In a randomized prospective controlled trial involving 311 patients undergoing acute or elective colorectal surgery, the efficacy and safety of two different single dose and one triple dose regimen of antibiotic prophylaxis, as well as the influence of blood transfusion on postoperative infectious complications, were studied. Postoperative infectious complications occurred in a total of 59 patients (19.0 per cent). There were no major differences between the three treatment groups. Thirty-four patients (10.9 per cent) developed abdominal wound infection, 17 patients (5.5 per cent) intra-abdominal abscess and 16 patients (5.1 per cent) anastomotic leakage. Of 202 patients (65.0 per cent) requiring blood transfusion during hospitalization 57 (28.2 per cent; 95 per cent confidence limits of 23-36 per cent) developed infectious complications, whereas two non-transfused patients (1.8 per cent; 95 per cent confidence limits of 0.2 to 6 per cent; P less than 0.001) developed infectious complications. It is concluded that one single dose of antibiotic prophylaxis in acute and elective colorectal surgery is as protective as a triple dose regimen. The development of infectious complications despite antibiotic prophylaxis is strongly related to blood transfusion. Elective colorectal surgery carries a rate of septic complications of up to 35% in patients not receiving prophylaxis. This can be reduced to 5% in patients receiving appropriate prophylactic agents. The safety and efficacy of cefonicid, a new cephalosporin with a half-life of 4-5 hr, were compared with those of cefoxitin for prophylaxis in patients undergoing elective colorectal procedures or surgery for obstruction of the small bowel. Fifty-seven assessable patients were randomly assigned in a double-blind fashion to therapy with 1 g of cefonicid intravenously (iv) or intramuscularly (im) 1 hr before surgery only or 2 g of cefoxitin iv or im 1 hr before surgery and 2 g every 6 hr for 24 hr. Groups were comparable in terms of underlying diseases. Samples for blood culture were obtained immediately before and after surgery and at 8:00 A.M. on the first and second postoperative days. No blood cultures were positive. Two of 30 patients receiving cefonicid developed wound infections (6%). Two of 27 patients receiving cefoxitin developed wound infections, and one developed an intraabdominal abscess (11%). No significant adverse effects were noted. The results suggest cefonicid may be an effective prophylactic antibiotic for bowel surgery. Most importantly, cefonicid offers the advantages associated with the administration of a single daily dosage, among which are reduction of pharmacy costs and the freeing of nursing hours for patient care. A consecutive series of 509 patients undergoing abdominal surgery were entered into a randomized, observer and patient blind, controlled, prospective, study to evaluate the efficiency of co-amoxiclav ('Augmentin', SmithKline Beecham, UK) compared with cefuroxime ('Zinacef', Glaxo, UK) plus metronidazole (Flagyl, M&B, UK) for the prevention of postoperative wound infections. One or three doses of antibiotics were given depending on the type of surgery and operative factors. Co-amoxiclav was given to 230 patients with a total wound infection rate of 5.6% and cefuroxime plus metronidazole were given to 225 patients with a total wound infection rate of 3%. The difference between infection rates was not significant. Both groups were comparable in terms of demographic details, type and duration of surgery, risk factors associated with surgical procedures and postoperative management. Although not statistically significant, a difference in the wound infection rate for those patients undergoing colorectal surgery was seen: 8/69 for the co-amoxiclav group and 2/79 for the cefuroxime/metronidazole group. The estimated cost to our hospital (October, 1993) of one dose of co-amoxiclav was less that half the cost of cefuroxime and metronidazole. This study demonstrates that co-amoxiclav is an effective prophylactic antibiotic for abdominal surgery. The preliminary results of four multicenter, comparative protocols on the efficacy and safety of aztreonam are discussed. This monobactam antibiotic was used as short-term prophylaxis in patients undergoing colorectal, gynecologic or urologic surgery. When compared with gentamicin in a group of 295 patients undergoing colorectal surgery, aztreonam significantly reduced the incidence of abdominal wound infection (p less than 0.025); it also reduced the incidence of perineal wound and intra-abdominal infections, although these differences were not statistically significant. In patients undergoing abdominal and vaginal hysterectomy, aztreonam was compared with cefotaxime (both combined with clindamycin) in 170 and 142 patients, respectively. No difference in the incidence of infection was found between the two treatment regimens. In the 175 patients undergoing transurethral resection of the prostate, aztreonam was compared with placebo. The prophylactic regimen significantly reduced the number of urinary tract infections (p less than or equal to 0.0001). Its efficacy was particularly evident during the first 10 postoperative days. Side effects experienced by patients taking aztreonam were minor and similar in all three treatment groups studied. Aztreonam (alone or combined with clindamycin) offers a new and efficacious alternative to the standard antibiotic regimens currently used prophylactically in the high-risk postoperative patient. Mesalazine as maintenance therapy in ulcerative colitis is used worldwide and has been proven to be effective. However, the optimal dosage remains to be defined.
                To establish whether daily treatment with 2.4 g of oral mesalazine is more effective than 1.2 g in preventing disease relapse.
                A total of 156 patients with ulcerative colitis in remission were randomly treated for 1 year with 2.4 (n = 80) or 1.2 (n = 76) g/day of mesalazine. Activity of disease was assessed by periodical clinical, endoscopic and histological examinations.
                After 12 months, 24 of 80 patients (30%) on 2.4 g and 20 of 76 patients (26%) on 1.2 g were still in remission (P = N.S.). Patients in 2.4 g group remained in remission for a longer time than those in 1.2 g group (P < 0.001). Among clinical variables considered in the study, course of disease prior to enrollment (< or = 3 or > 3 relapses/year) was found to influence response to therapy.
                A daily dosage of 2.4 g of oral mesalazine seems to better at preventing and delaying relapses of ulcerative colitis than 1.2 g. The course of disease seems to be crucial in choosing the optimal dosage of mesalazine in a maintenance regimen. A prospective, blinded, placebo-controlled study was performed to determine the minimum effective duration of short-term antibiotic prophylaxis following cesarean section. Cefoxitin was selected as the study drug, and 189 women at high risk for postoperative infectious morbidity were randomly assigned to three cohorts, each receiving intravenous infusions at cord clamping and at 4 and 8 hours postoperatively. The incidence of endometritis in the placebo group was 29.3% versus 9.4% in patients receiving one dose of cefoxitin (2 gm) at cord clamping and 5.0% in patients receiving three doses of cefoxitin (p less than 0.0001). Cefoxitin prophylaxis significantly reduced the incidence of endometritis in patients with postoperative anemia. There were no serious complications or drug reactions in the treated groups. Sulfasalazine is well established in the treatment of active ulcerative colitis. Intolerance to sulfasalazine, however, is a common problem. Balsalazide has been designed to deliver 5-aminosalicylic acid to the colon without the poor tolerability of sulfasalazine.
                To compare the safety and efficacy of balsalazide, 6.75 g daily, with sulfasalazine, 3 g daily, in the treatment of active ulcerative colitis of all grades of severity.
                Balsalazide and sulfasalazine were compared in a multicentre, double-blind, parallel group study over 12 weeks. Patients were stratified for disease severity and topical and/or oral steroids were co-administered where clinically necessary.
                Fifty-seven patients were randomized: 28 to receive balsalazide and 29 to receive sulfasalazine. Significantly fewer patients withdrew from the balsalazide group due to adverse events (2/28 vs. 9/29, P=0.041). These data confirm that balsalazide is better tolerated than sulfasalazine. In patients able to tolerate the treatment, similar improvements were recorded in clinical, sigmoidoscopic and histological assessments in both treatment groups.
                This study confirms the better tolerability of balsalazide compared to sulfasalazine, and supports the use of balsalazide in ulcerative colitis of all grades of severity. Prophylactic antibiotic treatment in elective laparoscopic cholecystectomy does not lower the already low infection rate associated with this procedure.
                Prospective double-blind randomized trial at a community-based training hospital.
                Four hundred fifty patients undergoing elective laparoscopic cholecystectomy were randomized into 1 of 3 treatment arms: (1) preoperative cefotetan disodium, 1g intravenously; (2) preoperative cefazolin, 1g intravenously; and (3) intravenous placebo. There were no demographic differences between groups in age, smoking history, American Society of Anesthesiologists score, infection risk class, time of antibiotic administration prior to surgery, and type of skin preparation.
                Laparoscopic cholecystectomy was attempted in all cases; however, 10 patients required conversion to an open cholecystectomy and they were included in the statistical analysis. Preoperatively, all patients were randomized in a blinded manner and received cefotetan, cefazolin, or placebo intravenously.
                There were 10 postoperative infections. In the cefotetan group, there were 3 cases of superficial surgical site infections. In the cefazolin group, there were 2 superficial surgical site infections-1 pneumonia and 1 rhinosinusitis. In the placebo group, there were 2 superficial surgical site infections and 1 urinary tract infection. The overall infection rate in this series was 2.4%. Follow-up was performed at routine postoperative visits and by telephone contact. Data were evaluated using the chi2 test and analysis of variance with Duncan post hoc test (P<.05).
                Based on our data, use of prophylactic antibiotics does not decrease the rate of wound infections in elective laparoscopic cholecystectomy. The prophylactic use of a single dose of lincomycin in 100 patients undergoing appendicectomy reduced the incidence of postoperative wound infection from 17 to 6 per cent compared with a similar group of control patients. There was no correlation with the histological finding in the appendix, but patients with perforated appendicitis were excluded from the study. Bacteriological examination of the appendix area before surgery showed that Bacteroides fragilis and Escherichia coli were the organisms most frequently isolated. The majority of wound infections were due to B. fragilis, either alone or in association with aerobic organisms, but infection due to E. coli and Staphylococcus aureus also occurred. Systemic antibiotic therapy can successfully reduce the complications following appendicectomy but it is necessary to use a compound with activity against anaerobic organisms. The role of vancomycin and other antibiotics in the treatment of acute peritonitis in peritoneal dialysis (PD) patients is well established. However, the role of preoperative vancomycin or cephalosporins in preventing early infection in newly placed PD catheters remains controversial. We performed a prospective randomized study to examine the role of vancomycin or cefazolin prophylaxis in decreasing the incidence of postoperative peritonitis. Over a 6-year period, 221 patients undergoing 254 permanent peritoneal catheter placement procedures were randomized into three groups. Group I patients (86 procedures) were administered a single intravenous (IV) dose of vancomycin, 1,000 mg, 12 hours before peritoneal catheter placement procedures, whereas group II patients (85 procedures) were administered a single IV dose of cefazolin, 1,000 mg, 3 hours before the procedure. Group III patients (83 procedures) were not administered antibiotics preoperatively for at least 1 week before the procedure. Patients were monitored for peritonitis in the following 14 days. Peritonitis developed in 1 patient (1%) in group I (vancomycin group) and 6 patients (7%) in group II (cefazolin group) compared with 10 patients (12%) in group III (control group); P = 0.02. We conclude that the use of preoperative single-dose IV vancomycin prophylaxis for permanent PD catheter placement reduces the risk for postoperative peritonitis. Single-dose vancomycin is superior to single-dose cefazolin in reducing the risk for postoperative peritonitis. Absence of prophylaxis is associated with a high risk for developing postoperative peritonitis. Aztreonam/metronidazole and cefotaxime/metronidazole were compared in a prospective trial in 154 patients undergoing elective colorectal surgery. Three antibiotic doses were given over 16 hours. A significant excess of wound sepsis in the aztreonam group was seen (23/71 vs 9/70 chi 2 6.60; P less than 0.01). Sepsis was almost invariably due to Gram-positive organisms and, in particular, Staphylococcus aureus. A double-blind study of 73 patients was undertaken to evaluate the prophylactic effect of short-term metronidazole in caesarean section. Metronidazole, 500 mg, given intravenously prior to making the incision, followed by 2 g, rectally, on completion of surgery failed to reduce the incidence of infection post-operatively. There was no reduction in the number of patients requiring antibiotics or in the quantity of post-operative pyrexia, as assessed by the fever index. The incidence of post-operative pyrexia was not affected by the duration of ruptured membranes or the use of a fetal scalp electrode. In a series of 157 patients undergoing elective colorectal surgery, metronidazole or doxycycline was given to prevent infectious complications. The prophylaxis was started just before the operation and was administered for a total of three days. Excluding mild, negligible infections, 39 (25%) of the 157 patients had infectious complications, 23 from the metronidazole group (28%) and 16 from the doxycycline group (21%). The type of infection varied according to the medication. In four cases of the metronidazole group and 16 of the doxycycline group, anaerobic bacteria were found. The corresponding figures for aerobes were 36 and 20. Doxycycline thus was significantly more effective in preventing complications in general, but metronidazole gave superior protection against anaerobes. A randomized, double-blind comparative trial of cefoxitine and piperacillin was conducted in two groups of 30 patients with a similar number of the usual risk factors. Doses of cefoxitine 2 g and piperacillin 4 g were administered only once, except in some cases when the operation lasted more than 5 hours. Analysis of the results showed that the two antibiotics had equivalent prophylactic effectiveness (congruent to 6%) in colorectal surgery. To compare the efficacy, safety, and acceptability of treatment with intravenous antibiotics for cellulitis at home and in hospital.
                Prospective randomised controlled trial.
                Christchurch, New Zealand.
                200 patients presenting or referred to the only emergency department in Christchurch who were thought to require intravenous antibiotic treatment for cellulitis and who did not have any contraindications to home care were randomly assigned to receive treatment either at home or in hospital.
                Days to no advancement of cellulitis was the primary outcome measure. Days on intravenous and oral antibiotics, days in hospital or in the home care programme, complications, degree of functioning and pain, and satisfaction with site of care were also recorded.
                The two treatment groups did not differ significantly for the primary outcome of days to no advancement of cellulitis, with a mean of 1.50 days (SD 0.11) for the group receiving treatment at home and 1.49 days (SD 0.10) for the group receiving treatment in hospital (mean difference 0.01 days, 95% confidence interval -0.3 to 0.28). None of the other outcome measures differed significantly except for patients' satisfaction, which was greater in patients treated at home.
                Treatment of cellulitis requiring intravenous antibiotics can be safely delivered at home. Patients prefer home treatment, but in this study only about one third of patients presenting at hospital for intravenous treatment of cellulitis were considered suitable for home treatment. To assess the analgesic efficacy of diclofenac when administered as an adjuvant to bupivacaine wound instillation.
                Prospective, randomized, double blind, placebo-controlled study.
                Large referral hospital.
                90 women recovering from cesarean delivery performed via a Pfannenstiel incision.
                A standard intrathecal anesthetic was administered. On completion of surgery, a multiorifice 20-gauge epidural catheter was placed within the surgical wound. Postoperatively, the catheter was attached to a patient-controlled analgesia (PCA) device programmed to deliver 9 mL with a 60-minute lockout time and no basal infusion. In group bupivacaine-diclofenac, the PCA device delivered 0.25% bupivacaine, and 20 minutes before the end of surgery, patients received intravenous diclofenac (75 mg/100 mL saline). Thereafter, oral diclofenac (50 mg) was administered every 8 hours. In group bupivacaine-placebo, 0.25% bupivacaine and an equal volume of intravenous saline or oral placebo were administered 20 minutes before the end of surgery and every 8 hours thereafter. In group placebo-diclofenac, wound instillation was with sterile water, and 20 minutes before the end of surgery, patients received intravenous diclofenac (75 mg/100 mL saline) and thereafter oral diclofenac (50 mg) at 8-hour intervals. During the first 6 postoperative hours, a coinvestigator administered "rescue" morphine (2 mg, intravenously). Thereafter, subcutaneous morphine (0.05 mg/kg) was administered on patient request for additional analgesia.
                The number of attempts to activate the PCA device was significantly higher in group bupivacaine-placebo (39 +/- 32) when compared with group bupivacaine-diclofenac (24 +/- 28). During the first 6 postoperative hours, the number of patients requiring rescue morphine and the total rescue morphine administered were significantly different between the groups. During the subsequent 18 hours, subcutaneous morphine administration was significantly higher in group bupivacaine-placebo. Postoperative pain scores were significantly higher in group bupivacaine-placebo when compared with those recorded in groups placebo-diclofenac and bupivacaine-diclofenac. Finally, patient satisfaction was significantly lower in group bupivacaine-placebo.
                In the context of this study, the bupivacaine wound instillation with adjuvant diclofenac administration is associated with similar postoperative analgesia to that induced by diclofenac alone. The acute appendicitis is the most common abdominal emergency, and the primary treatment has been appendicectomy. Antibiotics are started preoperatively and continued postoperatively as needed.
                This prospective study was carried out at Sher-i-Kashmir Institute of Medical Sciences, Soura, Srinagar, Kashmir, India to determine the role of antibiotics as the only treatment in acute appendicitis and the analgesic consumption needed. Total of 80 patients were included in the study with a duration of abdominal pain less than 72 h. Out of 80 patients, 40 patients received antibiotics intravenously for 2 days followed by oral treatment for 7 days, while another 40 patients considered as controls were randomized to surgery.
                Patients managed conservatively were discharged within 3 days except for two--patients who required surgery after 12 and 24 h, respectively, because of peritonitis due to perforated appendicitis. Four patients were readmitted within 1 year as a result of recurrent appendicitis and had to undergo surgery when appendicitis was confirmed. The diagnostic accuracy within the operated group was 90%. Two patients had perforated appendicitis at operation.
                Our conclusion is that antibiotic treatment in the patients with acute appendicitis is quite effective, and these patients may not need surgery. The patients managed conservatively with antibiotics alone experience less pain and require less analgesia but have high recurrent rate. At present the use of prophylactic antibiotics in elective laparoscopic cholecystectomy is controversial. This prospective study was carried out to define the role of prophylactic antibiotics in elective laparoscopic cholecystectomy to prevent postoperative infection. Ninety three patients were randomly placed in two groups. Group A comprised of 40 while group B consisted of 53 patients. Patients in Group A received 1.5 grams of second generation cephalosporin (cefuroxime sodium) diluted in 100ml of normal saline, at the time of induction of anesthesia. Group B patients received an equal volume of normal saline only. A sample of gall bladder bile was collected by direct gall bladder puncture intra-operatively for aerobic and anaerobic culture. Age, sex, weight of the patient, American Society of Anesthesiologists classification grade, presence of diabetes mellitus, episodes of colic 30 days preceding surgery, intra-operative gall bladder rupture, stone and / or bile spillage, results of bile culture, gall bladder histology, length of hospital stay, and number of septic complications were recorded and analyzed. In group A, one patient (2.5%) had post operative wound infection and in group B, two patients (3.8%) had post operative infection which was statistically similar (p>0.1). There was no difference between the two groups in terms of demographic, intra operative and post operative denominators. Therefore the study concluded that prophylactic antibiotics did not have a significant role to play in prevention of postoperative wound infection in elective laparoscopic cholecystectomy. This randomized clinical trial compares the incidence of wound infection after vascular surgery in patients who received prophylaxis using the same antibiotic as either a single-dose or a multiple-dose regimen (until the lines/drain tubes were removed, but not for more than 5 days).
                Each of the 302 patients who entered the study received ticarcillin 3.0 g/clavulanate 0.1 g (Timentin) intravenously immediately after the induction of anesthesia. Patients randomized to the multiple-dose group received an average of 14.3 doses (range 9 to 20).
                The incidence of wound infections was 18% (28 of 153) for patients in the single-dose group and 10% (15 of 149) for patients in the multiple-dose group (P = 0.04; relative risk estimate = 2.00, 95% confidence interval = -1.02 to 3.92).
                A multiple-dose antibiotic regimen, rather than single-dose therapy, provides optimal prophylaxis against wound infection for patients undergoing vascular surgery. The optimal duration of antibiotic therapy in older patients with uncomplicated urinary tract infection (UTI) is still a matter of debate. The aim of this randomized controlled double-blind noninferiority trial was to compare the efficacy and safety of 3-day and 7-day courses of oral ciprofloxacin for uncomplicated symptomatic UTI in older women.
                A total of 183 women at least 65 years of age with acute uncomplicated UTI were recruited from ambulatory clinics and hospital acute care units. Patients with pyelonephritis, contraindications to fluoroquinolones, recent use of antibiotics, urinary tract abnormalities and diabetes mellitus were excluded. Women were randomly assigned to receive either ciprofloxacin 250 mg twice daily orally for 3 days followed by placebo for 4 days (the 3-day group, 93 patients) or ciprofloxacin 250 mg twice daily orally for 7 days (the 7-day group, 90 patients). Bacterial eradication, clinical improvement and occurrence of adverse events were determined 2 days after completion of treatment, and occurrence of reinfection or relapse were determined 6 weeks after completion of treatment. Bacterial eradication and relapse were determined by urine culture. Double-blind procedures were maintained throughout data collection.
                The proportion of patients with bacterial eradication at 2 days after treatment was 98% (91/93) in the 3-day group and 93% (83/89) in the 7-day group (p = 0.16). The frequency of adverse events, including drowsiness, headache, nausea or vomiting, and loss of appetite, was significantly lower in the 3-day group.
                These results suggest that a 3-day course of antibiotic therapy is not inferior to a 7-day course for treatment of uncomplicated symptomatic UTI in older women, and that the shorter course is better tolerated. A prospective, randomized, blinded study was performed to determine whether prophylactic antibiotics would reduce the incidence of infection in peripheral vascular surgery and whether the route of antibiotic administration was important. Patients undergoing a vascular procedure with a groin incision were allocated to one of four groups with respect to prophylactic antibiotics. Group I received no antibiotic. Group II had topical cephradine instilled in their incisions prior to closure. Group III received a 24-hour perioperative course of intravenous cephradine, and Group IV received both topical and intravenous cephradine. Groin and abdominal incisional infections were significantly reduced (p < 0.01) among patients who received prophylactic antibiotics by either the topical, systemic, or combined routes of administration. No significant differences were noted among the three antibiotic groups. Profundoplasty, femoral embolectomy, and femoral aneurysm repair were each associated with an increased incidence of infection (p < 0.01). Other risk factors were only important in patients not receiving antibiotics. Either intraoperative topical antibiotics or perioperative systemic antibiotics prevent infection in peripheral vascular surgery, but antibiotic administration by both routes is unnecessary. Antibiotic associated diarrhea due to human intestinal microbiota abnormalities is a side effect of H. pylori eradication therapy. We examined intestinal microbiota changes during H. pylori eradication therapy and the preventive effect of CBM588 as a probiotic agent. Nineteen patients with gastro-duodenal ulcer were randomly divided into three groups: group A (without probiotics), group B (with regular doses of CBM588) and group C (with double doses of CBM588). The incidence of diarrhea and soft stools during H. pylori eradication therapy was 43% in group A and 14% in group B, while none of the patients in group C reported diarrhea or soft stools. Both bacterial counts and detection rates of bifidobacteria and/or obligate anaerobe were decreased by eradication therapy. However, bacterial counts of obligate anaerobes in group C were significantly higher than in group A (P < 0.05). Additionally, during eradication therapy C. difficile toxin A was detected in both group A and group B but not in group C. In conclusion, these results indicate that H. pylori eradication therapy induces antibiotic associated diarrhea due to abnormalities in intestinal microbiota and/or C. difficile. However, these side effects might be prevented by probiotics. The impact of how positive blood culture results are reported on the evolution bloodstream infections (BSIs) has not been assessed.
                We randomly assigned patients with BSIs into 3 groups: group A (for which physicians received a conventional report), group B (for which physicians received a conventional report and a written alert on the chart with clinical advice), and group C (for which physicians received the above plus oral clinical advice). The adequacy of therapy before and after receipt of the different types of information was assessed.
                Overall, 297 episodes (109 in group A, 99 in group B, and 89 in group C) were studied. Patients who received inadequate treatment before receiving microbiological information had a longer mean (+/-SD) hospital stay (27.2+/-32.4 vs. 19.4+/-15.8 days; P=.017), a higher mean risk of Clostridium difficile-associated diarrhea (8.3% vs. 1.9%; P=.013), a higher mean overall mortality rate (30.8% vs. 19.4%; P=.025), and a higher mean risk of infection-related mortality (23.3% vs. 13.6%; P=.031). After receipt of microbiological reports, recommendations for changes in therapy were issued for patients in groups B (52.3%) and C (53.1%). For groups A, B, and C, the proportions of days on which adequate treatment was received were 66.3%, 92.1%, and 91.2% (P<.001); the mean numbers of defined daily doses of appropriate antibiotic therapy were 16.4, 22.2, and 20.7 (P=.003); the mean durations of hospital stay were 19.8, 23.6, and 24.1 days (P=.761); and the mortality rates during the late period were 12.9%, 15.6%, and 11% (P=.670), respectively. The mean costs of antimicrobials per episode in groups A, B, and C were 580.63, 537.98, and 434.53 (US707.85 dollars, US699.73 dollars, and US529.73 dollars, respectively).
                Written- or oral-alert reports with clinical advice should complement traditional microbiological reports for patients with BSIs. Preoperative core needle biopsies may increase the risk of surgical site infection (SSI) in breast cancer surgery. The purpose of this randomized trial was to determine whether a prophylactic antibiotic would prevent SSI under these conditions.
                Imaging-guided multiple core needle biopsies were performed one to two weeks prior to surgery to obtain confirmation of the presence of breast cancer. Then the patients were randomized to receive either a single intravenous dose of 1.0 g of dicloxacillin (n = 144) or placebo infusion of saline (n = 148) 30 min prior to operation. After breast surgery, incisional morbidity was monitored for 30 days. The number of SSIs was compared with that in 672 patients treated before the implementation of core needle biopsies.
                The patient characteristics and risk factors for SSI were similar in the antibiotic prophylaxis and placebo groups. The incidence of SSI was 7.2% (21/292) in the prospective trial compared with 6.8% (46/672) in the retrospective cohort (p = 0.890). The incidence of postoperative SSIs was 5.6% (8/144) in the dicloxacillin group and 8.8% (13/148) in the placebo group (p = 0.371). For the first two weeks, there was a non-significant trend to fewer SSIs in the antibiotic group (n = 1) than the placebo group (n = 4). Body mass index, smoking, or previous illness did not affect the likelihood of SSI.
                Core needle biopsy did not increase the incidence of SSI. Antibiotic prophylaxis did not prevent SSI, probably because so few infections occurred. A prospective, randomized, single-blind, controlled clinical trial was undertaken to compare two different prophylactic antibiotic single-dose regimens in patients undergoing elective colorectal surgery. Timentin, a combination of ticarcillin and clavulanic acid, was administered intravenously (3.1 g) to 87 patients. Mezlocillin, a semisynthetic penicillin was given intravenously (2.0 g) to 98 patients. The wound infection rate was 10.6 percent in patients receiving Timentin and 9.7 percent in those receiving mezlocillin (P greater than .05). Multivariate analysis of factors possibly affecting the wound infection rate showed that the presence of a colostomy preoperatively, fecal contamination at surgery, and the surgical group were the only factors that independently achieved a statistically significant association with the development of a postoperative wound infection in this trial (P less than .0001). We conducted a prospective, randomized study to compare the efficacy of oral fusidic acid, oral metronidazole, oral vancomycin, and oral teicoplanin for the treatment of Clostridium difficile-associated diarrhea. Treatment resulted in clinical cure for 94% of the patients who were treated with vancomycin, 96% of those treated with teicoplanin, 93% of those treated with fusidic acid, and 94% of those treated with metronidazole. Clinical symptoms recurred in 16% of patients treated with vancomycin, 7% of those treated with teicoplanin, 28% of those treated with fusidic acid, and 16% of those treated with metronidazole. There was asymptomatic carriage of C. difficile toxin in 13% of patients treated with vancomycin, 4% of those treated with teicoplanin, 24% of those treated with fusidic acid, and 16% of those treated with metronidazole. No adverse effects related to therapy with vancomycin or teicoplanin were observed. Considering the costs of treatment, our findings suggest that metronidazole is the drug of choice for C. difficile-associated diarrhea and that glycopeptides should be reserved for patients who cannot tolerate metronidazole or who do not respond to treatment with this drug. Perhaps the most unpleasant experience following outpatient plastic surgery procedures is postoperative nausea and vomiting. Postoperative nausea and vomiting often results in delayed recovery time and unintended admission, and it can be a contributing factor to the formation of hematoma following rhytidectomy. Ondansetron (Zofran) has proven benefit in preventing postoperative nausea and vomiting if given before general anesthesia in a variety of surgical procedures. Its utility in cases performed under conscious sedation has not been determined. The purpose of this study was (1) to test the ability of prophylactic ondansetron to prevent postoperative nausea and vomiting in plastic surgery cases performed under conscious sedation, and (2) to determine relative risk factors for postoperative nausea and vomiting and a selection policy for the administration of antiemetic prophylaxis. This was a prospective, randomized, double-blind study. One hundred twenty patients were enrolled after giving informed consent. Patients received a single dose of either placebo or ondansetron (4 mg intravenously) before administration of sedation. Sedation administration followed a standardized institutional protocol, using midazolam and fentanyl. Data were recorded from a series of three questionnaires: preoperatively, immediately postoperatively, and at the time of the first office return. Data were confirmed by means of telephone interview, chart analysis, and nursing documentation. Multivariate analysis was conducted. Nausea and emesis occurred with an overall frequency of 33 percent and 22 percent, respectively. Postoperative nausea and vomiting was associated with statistically longer recovery periods. The incidence of emesis was statistically higher among women, among those undergoing facial rejuvenation, and among those with a history of opioid-induced emesis or postoperative nausea and vomiting following a previous operation (p < 0.05). The incidence of postoperative nausea and vomiting paralleled increases in case duration; the incidence of emesis was zero in cases less than 90 minutes in duration. Ondansetron significantly reduced the incidence of emesis overall (placebo, 30 percent; ondansetron, 13 percent; p < 0.05). Postoperative perception of nausea was significantly lower among those who had received ondansetron (p < 0.05). These results confirm the efficacy of ondansetron for the prevention of postoperative nausea and vomiting in plastic surgery cases under conscious sedation. In those who are at increased risk, prophylaxis should be considered. Such risks include female gender, facial rejuvenation procedures, and a patient history of opioid-induced emesis or postoperative nausea and vomiting following a prior operation. The zero incidence of emesis in cases less than 90 minutes does not support the routine use of prophylaxis in such cases. Patient satisfaction in plastic surgery is derived from the overall subjective experience of the event as much as by the final result. By remaining attentive to patient concerns and optimizing perioperative care, we can improve the subjective experience for our patients. To investigate the optimal duration of oral HCFU administration for minimization of side effects induced by long-term administration.
                In total, 155 patients allocated to two groups of different duration of the therapy were reviewed: twice or three times per day doses of oral HCFU (8 mg/Kg body weight/day) for 3 months vs. 12 months.
                Though statistically significant difference was not found in cumulative survival and disease-free rates between the groups due to so many violations of duration of therapy, when reanalyzing the variables in order of real duration of therapy, those rates were significantly higher in patients treated for 300 and more days than less than 300 days (g-Wilcoxon test: p < 0.04). No significant difference was observed in the background factors between the groups.
                At least 300 days is suggested to be necessary to obtain the optimal effectiveness of adjuvant chemotherapy for curatively resected colorectal cancer. Short-term prophylaxis against infection using cephalothin and cephalexin was studied in 140 patients operated on for trochanteric fractures of the femur. The group given the drug during preparation for anesthesia, intraoperatively, and for two days postoperatively had an infection rate of 1.8 per cent (one patient), whereas the group without prophylaxis had a rate of 16.9 per cent (twelve patients). The two groups were similar with regard to factors that may have influenced the infection rate, for example, age, time required for surgery, and blood loss. Staphylococcus aureus was the most common infecting organism, but several patients had mixed infections with intestinal bacteria. The efficacy of administering an antibiotic prior to IUD insertion to reduce the risk of introducing an upper genital tract infection during the procedure has not yet been established. Two double-blind randomized studies conducted in Africa comparing a 200 mg prophylactic dose of doxycycline with a placebo did not conclusively identify a reduced risk of post-insertion pelvic inflammatory disease (PID). A clinical trial of comparable design is currently under way in the US. This multi-site trial will evaluate whether use of an antibiotic prior to insertion reduces the risk of IUD removal for all medical reasons, including upper genital tract infection, within the first three months after insertion. This paper reports on the pilot phase of this study, which was designed to test the protocols and data collection instruments in advance of the full-scale clinical trial. A total of 447 prospective IUD (TCu-380A) users were randomly assigned to receive either a 200 mg dose of doxycycline or a placebo one hour before IUD insertion. 3.6% (8/219) of participants who received the antibiotic had the device removed for medical reasons (infection, bleeding, cramping, etc.) within three months post-insertion compared to 4.5% (10/223) of participants who received the placebo. This reduction in the removal rate was not statistically significant given the limited size of the pilot study (RR = 0.81; 95% CI 0.28-2.29). Only two subjects, one from each treatment group, met the diagnostic criteria for acute PID. The overall three-month retention rate was 91.8% for the antibiotic group and 89.7% for the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS) Zinc deficiency is a common nutritional problem in adult sickle-cell disease (SCD) patients. Hyperzincuria and increased requirement of zinc due to continued hemolysis in SCD are probable bases for zinc deficiency in these patients. Zinc deficiency affects adversely T-helper1 (TH1) functions and cell mediated immunity and interleukin (IL)-2 production is decreased in zinc deficient subjects. We hypothesized that zinc supplementation will improve T-helper1 function and decrease incidence of infections in patients with SCD. We tested this hypothesis in 32 SCD subjects who were divided in three groups (Grs A, B, and C). Grs A (n = 11) and B (n = 10) were zinc deficient based on cellular zinc criteria and Gr C (n = 11) were zinc sufficient. Gr A subjects were observed for 1 year (baseline), following which they received zinc acetate (50 to 75 mg of elemental zinc orally daily) for 3 years. Gr B subjects were observed for 1 year (baseline), following which they received placebo for 1 year and then switched to zinc supplementation (50 to 75 mg of elemental zinc orally daily) for 2 years. Gr C subjects did not receive any intervention inasmuch as they were zinc sufficient. Prolonged zinc supplementation resulted in an increase in lymphocyte and granulocyte zinc (P = 0.0001), and an increase in interleukin-2 production (P = 0.0001), decreased incidence of documented bacteriologically positive infections (P = 0.0026), decreased number of hospitalizations and decreased number of vaso-occlusive pain crisis (P = 0.0001). The predominant pathogens isolated were staphylococci and streptococci involving the respiratory tract and aerobic gram-negative bacteria, particularly Escherichia coli, involving the urinary tract. Further confirmation of our observations will require prospective studies of zinc supplementation in a larger number of SCD patients.
                Copyright 1999 Wiley-Liss, Inc. 97 patients scheduled to undergo elective surgery for colorectal carcinoma were randomized to receive either three doses of intravenous metronidazole-e and tobramycin or three doses of intravenous metronidazole alone. The first dose was given after induction of general anesthesia, the second at 9 p.m. and the third at 6 a.m. the following day. The study was double-blind, with patients in the metronidazol-alone group given a placebo infusion instead of tobramycin. The overall postoperative infection rate was 19.6% with no statistically significant difference between the two groups. It is concluded that the addition of an aminoglycoside does not afford better protection than prophylaxis with metronidazole alone. 544 children operated upon for uncomplicated appendicitis were randomised into three groups. Group I received no antibiotics, patients in Group II were administered one single pre-operative dose of metronidazole (10 mg/kg) and patients in Group III received both both metronidazole (20 mg/kg) and cefuroxime (50 mg/kg) in a single preoperative dose. The rate of infectious complications in Group I was 6.3% but only 2.1 and 2.3 in Groups II and III, respectively. Among patients with a normal appendix or patients with simple appendicitis there was no difference in the rate of post-operative infections between the three different groups. However, in patients with gangrenous appendicitis the rate of postoperative infections was significantly lower in the two groups who received preoperative antibiotics (1.8% and 3.0% respectively) than in the group receiving no prophylactic antibiotics (infection rate 14%). It is concluded that a single preoperative dose of metronidazole significantly decreases the rate of postoperative infectious complications in children with appendicitis. No further improvement could be demonstrated if cefuroxime against aerobic organisms was added. This prospective multicenter study investigated the effect of hospital caseload on early postoperative outcome of surgery for carcinoma of the colon in 75 German hospitals and included 2293 patients. The hospitals were divided into those with a caseload of 1-30 (group A), 31-60 (group B), and more than 60 (group C) operations. Increasing caseload was associated only with fewer general postoperative complications. It was also associated with significantly greater use of antibiotic prophylaxis. No significant differences between the groups were found in resection rates, intraoperative complications, specific postoperative complications, overall postoperative morbidity, hospital mortality, or 30-day mortality. The significance of hospital caseload for the short-term postoperative outcome following surgery on the colon should not be overestimated. Basing conclusions about the results to be expected simply on the case volume is impermissible. On the basis of the available data it is not possible to establish a threshold value, that is, a minimum number of required operations. To determine the efficacy of selective decontamination of the digestive tract (SDD) in patients undergoing elective transplantation of the liver.
                Randomized, double-blind, placebo-controlled study.
                Two academic teaching hospitals.
                Adult patients undergoing elective liver transplantation: 26 patients receiving SDD and 29 patients receiving a placebo.
                Patients undergoing SDD were administered 400 mg of norfloxacin once daily as soon as they were accepted for transplantation. Postoperative treatment for this group consisted of 2 mg of colistin, 1.8 mg of tobramycin, and 10 mg of amphotericin B, four times daily, combined with an oral paste containing a 2% solution of the same drugs until postoperative day 30. Prophylactic intravenous administration of antibiotics was not part of the SDD regimen in this study. Control patients were given a similar regimen with placebo drugs.
                The mean number of postoperative bacterial and fungal infections in the first 30 days after transplantation was the primary efficacy end point. Days on a ventilator, days spent in the intensive care unit, and medical costs were registered as secondary outcome variables.
                Of the 26 patients undergoing SDD, 22 (84.5%) developed an infection in the postoperative study period; in the placebo group (n = 29), these numbers were not significantly different (25 patients, 86%). The mean number of postoperative infectious episodes per patient was also not significantly different: 1.77 (SDD) vs. 1.93 (placebo). Infections involving Gram-negative aerobic bacteria and Candida species were significantly less frequent in patients receiving SDD (p <.001 and p <.05). Total costs were higher in the group receiving SDD.
                Selective decontamination of the digestive tract does not prevent infection in patients undergoing elective liver transplantation and increases the cost of their care. It does, however, affect the type of infection. Infections with Gram-negative bacilli and with Candida species are replaced by infections with Gram-positive cocci. To investigate if oral, nonabsorbable antibiotics prevent bacterial infections in cirrhotics with gastrointestinal hemorrhage, 140 consecutive patients were randomly allocated into two groups: 68 patients (Group I) were given oral, non absorbable antibiotics (gentamicin + vancomycin + nystatin or neomycin + colistin + nystatin) from the inclusion into the trial up to 48 hr after cessation of the hemorrhage, or until emergency surgery or death in those cases who continued bleeding; and 72 patients (Group II) did not receive oral, nonabsorbable antibiotics. Both groups were similar in relation to clinical and laboratory data and characteristics of the hemorrhage. The incidence of infection was significantly lower in Group I than in Group II (11 patients in Group I and 25 in Group II developed proved infections; p less than 0.025). This difference was due to the fact that spontaneous bacteremia and peritonitis and urinary tract infection caused by enteric bacteria occurred almost exclusively in Group II. Two patients of Group I and 10 of Group II developed spontaneous bacteremia and/or peritonitis caused by enteric bacteria (p less than 0.025). These results indicate that prophylactic administration of oral, nonabsorbable antibiotics markedly reduces the incidence of infections caused by enteric bacteria in cirrhotic patients with gastrointestinal hemorrhage. Cholangitis and pancreatitis are severe complications of endoscopic retrograde cholangiopancreatography (ERCP). Antibiotics have been considered important in preventing cholangitis, especially in those with jaundice. Some have suggested that bacteria may play a role in the induction of post-ERCP pancreatitis. It is not clear, however, whether the incidence of post-ERCP pancreatitis could be reduced by antibiotic prophylaxis, as is the case with septic complications. In this prospective study, a total of 321 consecutive patients were randomized to the following two groups: (1) a prophylaxis group (n = 161) that was given 2 g of cephtazidime intravenously 30 minutes before ERCP, and (2) a control group (n = 160) that received no antibiotics. All patients admitted to the hospital for ERCP who had not taken any antibiotics during the preceding week were included. Patients who were allergic to cephalosporins, patients with immune deficiency or any other condition requiring antibiotic prophylaxis, patients with clinical jaundice, and pregnant patients were excluded. In the final analysis six patients were excluded because of a diagnosis of bile duct obstruction but with unsuccessful biliary drainage that required immediate antibiotic treatment. The diagnosis of cholangitis was based on a rising fever, an increase in the C-reactive protein (CRP) level, and increases in leukocyte count and liver function values, which were associated with bacteremia in some. The diagnosis of acute pancreatitis was based on clinical findings, and increases in the serum amylase level (>900 IU/L), CRP level, and leukocyte count with no increase in liver chemical values. The control group had significantly more patients with post-ERCP pancreatitis (15 of 160 in the prophylaxis group vs. 4 of 155 in the control group; P = 0.009) and cholangitis (7 of 160 vs. 0 of 155; P = 0.009) compared to the prophylaxis group. Nine patients in the prophylaxis group (6%) and 15 patients in the control group (9%) had remarkably increased serum amylase levels (>900 IU/L) after ERCP, but clinical signs of acute pancreatitis with leukocytosis, CRP reaction, and pain developed in four of nine patients in the prophylaxis group compared to 15 of 15 patients with hyperamylasemia in the control group (P = 0.003). In a multivariate analysis, the lack of antibiotic prophylaxis (odds ratio 6.63, P = 0.03) and sphincterotomy (odds ratio 5.60, P = 0.05) were independent risk factors for the development of post-ERCP pancreatitis. We conclude that antibiotic prophylaxis effectively decreases the risk of pancreatitis, in addition to cholangitis after ERCP, and can thus be routinely recommended prior to ERCP. These results suggest that bacteria could play a role in the pathogenesis of post-ERCP pancreatitis The study was undertaken to compare the efficacy, safety, and maternal satisfaction of oral misoprostol and intravenous oxytocin for labor induction in women with premature rupture of membranes at term.
                One hundred five women were stratified by parity and randomly assigned to oral misoprostol 75 microg every 4 hours as needed to establish labor or to intravenous oxytocin.
                The induction to vaginal delivery time with oral misoprostol was 737 (+/-426) minutes compared with 573 (+/-318) minutes with oxytocin (P=.04). The incidence of hyperstimulation was lower in the misoprostol group (6.0% vs 27.1%, P=.005). Women were more likely to be very satisfied with their care in the misoprostol group (86.0% vs 63.4%, P=.02).
                In women at term with premature rupture of membranes, oral misoprostol resulted in a longer induction to vaginal delivery interval but increased maternal satisfaction and less hyperstimulation compared with intravenous oxytocin. Further research is needed to assess uncommon neonatal and maternal outcomes. Neutropenic fever is one of the most serious adverse effects of cancer chemotherapy. Neutropenia may cause a life-threatening bacterial infection. Therefore, febrile neutropenic inpatients are empirically treated with intravenous broad-spectrum antibiotics. Recently, several studies have suggested the presence of low-risk groups among febrile neutropenic patients.
                A prospective randomized trial was conducted to compare treatment with oral ciprofloxacin (200 mg) and amoxicillin-clavulanate (375 mg) administered every 8 h against that with intravenous ceftazidime (1 g) administered every 12 h in low-risk febrile neutropenic patients with lung cancer. All patients received chemotherapy and antibiotic therapy while being hospitalized.
                A total of 177 patients with lung cancer agreed to participate in this study prior to undergoing chemotherapy. Among them, a total of 36 neutropenic patients with 42 febrile episodes were enrolled in the study. Treatment was successful without the need for modification in 91% of the episodes in patients receiving the oral regimen and 79% of the episodes in patients receiving the intravenous regimen. No treatment-related deaths occurred. One patient developed nausea while receiving the oral regimen, so the oral regimen was changed to the intravenous regimen in this patient.
                This prospective study suggested that treatment with oral antibiotics ciplofloxacin plus amoxicillin-clavulanate was effective for low-risk febrile neutropenic patients after chemotherapy. Medical treatment of uncomplicated acute diverticulitis is not standardized, and there is an enormous diversity in clinical practice. Our aim was to demonstrate that uncomplicated diverticulitis can be managed with orally administered amoxicillin plus clavulanic acid and a short hospital admission.
                A prospective randomized trial was established to compare patients with uncomplicated diverticulitis who received oral antibiotic after a short course of intravenous antibiotic with those who received intravenous antibiotic for a longer period. The antibiotic treatment consisted of amoxicillin plus clavulanic acid 1 g every 8 h. We included 50 patients, 25 in each group. Patients in group 1 began oral antibiotic as soon as they improved and were discharged the day after. Patients in group 2 received intravenous antibiotic for 7 days. Both groups received oral antibiotic at discharge. The endpoint of the study was "failure of treatment," which was defined as the impossibility of discharging on the expected day, emergency admission, or hospital readmission.
                Both groups were comparable in patient demographics and clinical characteristics. Most patients clearly improved between 24 and 48 h after admission. There were no significant differences between the groups when comparing failure of treatment. Treatment of patients in group 1 represented a savings in hospitalization costs of 1,244<euro> per patient.
                Most patients with uncomplicated diverticulitis can be managed safely with oral antibiotic; thus, a very short hospital stay is a safe option. In an open prospective study of postoperative infectious complications, patients undergoing elective colorectal surgery were randomly allocated to one of three groups receiving parenteral single-dose antimicrobial prophylaxis (1 g or 3 g metronidazole or 1 g metronidazole + 3 g nalidixic acid). Because of an unacceptably high rate of surgical infection in all three groups (36%, 29% and 39%, p greater than 0.1) among the first 103 evaluable patients, the study was discontinued. Nalidixic acid--though effective in in vitro tests of bacterial susceptibility--thus was found to be of little or no value as prophylaxis against Gram-negative infection. As the observed infection rate when metronidazole was given at the start of operation was seven-fold that previously found in the same department when 1 g metronidazole was administered 3-4 hours preoperatively (28/103 vs. 2/50, p less than 0.01), the timing of metronidazole prophylaxis was assumed to be potentially important for its ability to protect also against aerobic postoperative infection. In an effort to reduce infection rates in elective colorectal surgery to acceptable levels without oral non-absorbable antimicrobials, using only a short course of systemic antimicrobials, 50 patients were studied in a multicentre trial. Each patient received metronidazole for anti-anaerobic coverage. The anti-aerobic coverage consisted of netilmicin, cefuroxime or placebo, administered in a double-blind manner. Five out of 36 evaluable patients had an infection at the operation site. Two patients had peritonitis (one metronidazole-netilmicin and one metronidazole-placebo) and three had a wound abscess in the abdominal wall (all metronidazole-placebo). It is concluded that a short course of peroperative systemic prophylaxis with metronidazole and netilmicin or cefuroxime--without the use of oral non-absorbable antimicrobials--gave acceptable results in the centres studied. Thirty-one patients were randomized during 39 episodes of bleeding to receive either 1 g of intravenous cefotaxime (19 patients) or no antibiotic (20 patients) immediately before emergency endoscopic sclerotherapy. Blood was obtained for culture before and at 5 minutes, 4 hours, and 24 hours after the procedure. Specimens for culture were taken from the endoscope tip and channel, water bottle, and injection needle after sclerotherapy. When ascites was present (5 patients in the antibiotic group, 7 in the control group), fluid was obtained by paracentesis before endoscopy and at 4 and 24 hours. Bacteremia occurred in 1 of 19 patients in the antibiotic group (5.3%), compared with 6 of 19 in the control group (31.6%; p = .04). The cultured organisms were oral flora and usually also contaminated the endoscope and needle. No bacteria were cultured from ascitic fluid in any patient nor was the ascitic fluid white cell count elevated. Clinical infection attributable to sclerotherapy did not develop in any patient. In conclusion, the frequency of bacteremia after endoscopic sclerotherapy for bleeding esophageal varices can be reduced by prophylactic administration of intravenous cefotaxime. However, this may not be clinically relevant, given the absence of bacterascites and infection in this study. These findings do not support the routine use of antibiotics before sclerotherapy.
Antibiotics covering aerobic and aerobic bacteria should be delivered orally and intravenously prior to colorectal surgery.  Antibiotics delivered within this framework will reduce the risk of postoperative SWI by at least 75%.  Further research is required to establish the optimal timing and duration of dosing, and frequency of longer-term adverse effects such as Clostridium difficile pseudomembranous colitis.