Rifampin does not improve the efficacy of quinolone antibacterial prophylaxis in neutropenic cancer patients: results of a randomized clinical trial. Norfloxacin vs ceftriaxone in the prophylaxis of infections in patients with advanced cirrhosis and hemorrhage. Prophylactic antibiotics for the prevention of neutropenic fever in patients undergoing autologous stem-cell transplantation: results of a single institution, randomized phase 2 trial. Daily norfloxacin is more effective than weekly rufloxacin in prevention of spontaneous bacterial peritonitis recurrence. [Prophylaxis with fluoroquinolones in patients with neutropenia]. Benefit of prophylaxis by intravenous systemic vancomycin in granulocytopenic patients: a prospective, randomized trial among 59 patients. A comparison of cortisporin and ciprofloxacin otic drops as prophylaxis against post-tympanostomy otorrhea. Antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG): a prospective randomized clinical trial. Antibiotic prophylaxis of infectious complications with endoscopic retrograde cholangiopancreatography. A randomized controlled study. Co-trimoxazole alone for prevention of bacterial infection in patients with acute leukaemia. Trimethoprim-sulfamethoxazole prophylaxis in granulocytopenic patients with acute leukemia: evaluation of serum antibiotic levels in a randomized, double-blind, placebo-controlled Department of Veterans Affairs Cooperative Study. Prophylactic antibiotic treatment in patients with predicted severe acute pancreatitis: a placebo-controlled, double-blind trial. Decrease in nosocomial pneumonia in ventilated patients by selective oropharyngeal decontamination (SOD). [A study of non-antibiotic versus antibiotic prophylaxis for recurrent urinary-tract infections in women (the NAPRUTI study)]. Prophylactic use of fluconazole in neutropenic cancer patients. Randomized trial of the addition of gram-positive prophylaxis to standard antimicrobial prophylaxis for patients undergoing autologous bone marrow transplantation. [Parenteral antibiotic prophylaxis or oral antimicrobial bowel preparation for colorectal surgery (author's transl)]. Antibiotic prophylaxis in low-risk cesarean section. Effect of co-trimoxazole prophylaxis on morbidity, mortality, CD4-cell count, and viral load in HIV infection in rural Uganda. Selective decontamination of the digestive tract with norfloxacin in the prevention of ICU-acquired infections: a prospective randomized study. Effect of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV: randomised 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. Selective effect of cefoxitin prophylaxis on post-cesarean-section microbial flora. Post-ERCP pancreatitis: reduction by routine antibiotics. Total joint arthroplasty and incidence of postoperative bacteriuria with an indwelling catheter or intermittent catheterization with one-dose antibiotic prophylaxis: a prospective randomized trial. [Infection prevention in elective large intestine surgery. Results of a prospective randomized comparative study]. Levofloxacin prophylaxis to prevent bacterial infection in chemotherapy-induced neutropenia in acute leukemia. Perioperative antibiotic prophylaxis for prevention of postoperative neurosurgical infections. A randomized clinical trial. Co-trimoxazole as prophylaxis against opportunistic infections in HIV-infected Zambian children (CHAP): a double-blind randomised placebo-controlled trial. Switch therapy with ciprofloxacin vs. intravenous ceftazidime in the treatment of spontaneous bacterial peritonitis in patients with cirrhosis: similar efficacy at lower cost. Use of antibiotic prophylaxis in ear surgery. The role of antibiotic prophylaxis in mesh repair of primary inguinal hernias using prolene hernia system: a randomized prospective double-blind control trial. Randomised comparison of ceftazidime and imipenem as initial monotherapy for febrile episodes in neutropenic cancer patients. Quinolone-based antibacterial chemoprophylaxis in neutropenic patients: effect of augmented gram-positive activity on infectious morbidity. National Cancer Institute of Canada Clinical Trials Group. Antibiotic prophylaxis in vascular reconstructive surgery: a double-blind placebo-controlled study. Clinical trial of prophylaxis of wound sepsis in elective colorectal surgery comparing ticarcillin with tinidazole. University of Melbourne Colorectal Group. [Short or long schemes of antibiotic prophylaxis for prostate biopsy. A multicentre prospective randomised study]. Influence of combined intravenous and topical antibiotic prophylaxis on the incidence of infections, organ dysfunctions, and mortality in critically ill surgical patients: a prospective, stratified, randomized, double-blind, placebo-controlled clinical trial. Short-term prophylaxis with cefuroxime in colorectal surgery for cancer. A prospective, randomized, double-blind study of trimethoprim-sulfamethoxazole for prophylaxis of infection in renal transplantation: clinical efficacy, absorption of trimethoprim-sulfamethoxazole, effects on the microflora, and the cost-benefit of prophylaxis. Post-cesarean section febrile morbidity. Antibiotic prophylaxis in low-risk patients. Antibiotic prophylaxis and open groin hernia repair. Ketoconazole versus nystatin plus amphotericin B for fungal prophylaxis in severely immunocompromised patients. Single-dose intraoperative antibiotic prophylaxis in emergency abdominal surgery. Single-dose peroperative antibiotic prophylaxis in gastrointestinal surgery. Single-dose antibiotic prophylaxis in osteosynthesis for hip fractures. A clinical multicentre study in Finland. A randomized, placebo-controlled study of the use of filgrastim in non neutropenic patients with nosocomial pneumonia. Chemoprophylaxis of bacterial infections in granulocytopenic patients with ciprofloxacin vs ciprofloxacin plus amoxicillin. Prophylaxis of fever and infection in adult cancer patients. A placebo-controlled trial of oral trimethoprim-sulfamethoxazole plus erythromycin. Low-dose, single-shot perioperative antibiotic prophylaxis in colorectal surgery. Ceftriaxone vs. ampicillin + metronidazole as prophylaxis against infections after clean-contaminated abdominal surgery. [Preventive preoperative antibiotic therapy in elective colon surgery. A controlled prospective randomized study]. Levofloxacin vs. ciprofloxacin plus phenethicillin for the prevention of bacterial infections in patients with haematological malignancies. Global report on preterm birth and stillbirth (3 of 7): evidence for effectiveness of interventions. Granulocyte colony-stimulating factor (G-CSF) with or without a quinolone in the prevention of infection in cancer patients. Selective bowel decontamination for the prevention of infection in acute myelogenous leukemia: a prospective randomized trial. Oral prophylaxis with neomycin and erythromycin in colorectal surgery. More proof for efficacy than failure. The role of antibiotic prophylaxis in prevention of wound infection after Lichtenstein open mesh repair of primary inguinal hernia: a multicenter double-blind randomized controlled trial. Use of trimethoprim-sulfamethoxazole to prevent bacterial infections in children with acute lymphoblastic leukemia. Systemic antibiotic prophylaxis after gastrointestinal hemorrhage in cirrhotic patients with a high risk of infection. [Perioperative remote infections in neurosurgery. Role of antibiotic prophylaxis]. Antibiotic prophylaxis of carriers of sulfadiazine-resistant meningococci. Comparison of norfloxacin and pefloxacin in the prophylaxis of bacterial infection in neutropenic cancer patients. Use of surfactant for prophylaxis versus rescue treatment of respiratory distress syndrome: experience from an Italian-Bulgarian trial. Antibiotic prophylaxis in acute nonperforated appendicitis. The Danish Multicenter Study Group III. Effect of antibiotic prophylaxis in percutaneous endoscopic gastrostomy. [Antibiotic prophylaxis in a priori cesarean sections without a high risk of infection. Experiences of a Tunisian maternity department]. Quality improvement of surgical prophylaxis in Dutch hospitals: evaluation of a multi-site intervention by time series analysis. Antibiotic prophylaxis after instrumentation for urodynamic testing. Changing surgical antimicrobial prophylaxis practices through education targeted at senior department leaders. Antibiotic prophylaxis for the prevention of recurrent urinary tract infection in children with low grade vesicoureteral reflux: results from a prospective randomized study. Effectiveness of ciprofloxacin prophylaxis in preventing bacteriuria caused by urodynamic study: a blind, randomized study of 192 patients. Bacteriologic effects of antibiotic prophylaxis in high-risk cesarean section. A prospective randomized study of prophylactic antibiotics in elective laparoscopic cholecystectomy. Antibiotic prophylaxis for percutaneous endoscopic gastrostomy--a prospective, randomised, double-blind trial. Mefloquine prophylaxis prevents malaria during pregnancy: a double-blind, placebo-controlled study. Prophylaxis for recurrent acute otitis media: a Brazilian study. [Antibiotic prophylaxis in cesarean sections without high risk of infection. Therapeutic trial of cefotetan versus placebo]. Levofloxacin to prevent bacterial infection in patients with cancer and neutropenia. Prospective assessment of the role of antibiotic prophylaxis in ERCP. [Antibiotic prophylaxis in colon surgery: cefazolin (Kefzol- ornidazole (Tiberal) versus cephazolin-placebo]. Failure of topically applied antibiotics, added to systemic prophylaxis, to reduce perineal wound infection in abdominoperineal excision of the rectum. Single-dose antibiotic prophylaxis in women undergoing elective caesarean section. 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. Systemic Timentin is superior to oral tinidazole for antibiotic prophylaxis in elective colorectal surgery. University of Melbourne Colorectal Group. Antibiotic prophylaxis for infectious complications after therapeutic endoscopic retrograde cholangiopancreatography: a randomized, double-blind, placebo-controlled study. Reducing infections among women undergoing cesarean section in Colombia by means of continuous quality improvement methods. Prophylaxis of respiratory distress syndrome by treatment with modified porcine surfactant at birth: a multicentre prospective randomized trial. Single-dose v. short-term antibiotic therapy for prevention of wound infection in general surgery. A prospective, randomized double-blind trial. Fluoroquinolone prophylaxis for bacterial infections in neutropenic patients with hematologic malignancies. A multicenter, randomized, double blind placebo-controlled trial of amoxicillin/clavulanate for the prophylaxis of fever and infection in neutropenic children with cancer.
To determine whether the addition of rifampin to a quinolone-based antibacterial prophylactic regimen in patients undergoing high-dose chemotherapy (HDC) with peripheral-blood stem-cell transplantation (PBSCT) decreases the incidence of neutropenia and fever, Gram-positive bacteremia, and infection-related morbidity.
                Patients with solid tumors undergoing HDC with PBSCT were randomized to receive prophylactic antibiotics with either ciprofloxacin 500 mg orally every 8 hours or the same ciprofloxacin regimen with rifampin 300 mg orally every 12 hours. Prophylaxis was started 48 hours before stem-cell reinfusion. Patients were monitored to document the occurrence of neutropenia and fever, incidence and cause of bacterial infection, time to onset and duration of fever, requirement for intravenous antimicrobials, and length of hospital admission.
                Sixty-five patients were randomized to receive ciprofloxacin and 65 to receive ciprofloxacin plus rifampin, and from these groups, 62 and 61 were assessable, respectively. The proportion of patients who developed neutropenia and fever was 87% in the group treated with ciprofloxacin and 78% in the group treated with ciprofloxacin and rifampin (P =.25). Although there was a trend toward a reduction in the overall incidence of bacteremia (12 v 4 patients), and Gram-positive bacteremia (8 v 2 patients) with the addition of rifampin, none of these comparisons was statistically significant (P =.05 and P =.09, respectively).
                The results of this study, which demonstrate that rifampin does not improve ciprofloxacin antibacterial prophylaxis in cancer patients undergoing HDC with PBSCT support but that it does increase the occurrence of undesirable side effects, do not support the routine use of rifampin in this setting. Oral norfloxacin is the standard of therapy in the prophylaxis of bacterial infections in cirrhotic patients with gastrointestinal hemorrhage. However, during the last years, the epidemiology of bacterial infections in cirrhosis has changed, with a higher incidence of infections caused by quinolone-resistant bacteria. This randomized controlled trial was aimed to compare oral norfloxacin vs intravenous ceftriaxone in the prophylaxis of bacterial infection in cirrhotic patients with gastrointestinal bleeding.
                One hundred eleven patients with advanced cirrhosis (at least 2 of the following: ascites, severe malnutrition, encephalopathy, or bilirubin >3 mg/dL) and gastrointestinal hemorrhage were randomly treated with oral norfloxacin (400 mg twice daily; n = 57) or intravenous ceftriaxone (1 g/day; n = 54) for 7 days. The end point of the trial was the prevention of bacterial infections within 10 days after inclusion.
                Clinical data were comparable between groups. The probability of developing proved or possible infections, proved infections, and spontaneous bacteremia or spontaneous bacterial peritonitis was significantly higher in patients receiving norfloxacin (33% vs 11%, P = .003; 26% vs 11%, P = .03; and 12% vs 2%, P = .03, respectively). The type of antibiotic used (norfloxacin), transfusion requirements at inclusion, and failure to control bleeding were independent predictors of infection. Seven gram-negative bacilli were isolated in the norfloxacin group, and 6 were quinolone resistant. Non-enterococcal streptococci were only isolated in the norfloxacin group. No difference in hospital mortality was observed between groups.
                Intravenous ceftriaxone is more effective than oral norfloxacin in the prophylaxis of bacterial infections in patients with advanced cirrhosis and hemorrhage. One hundred and fifty-seven patients undergoing high-dose chemotherapy (HDT) and autologous stem-cell transplantation (ASCT) for hematopoietic malignancies and solid tumors were randomly assigned to receive (Group A) or not (Group B) prophylaxis with ciprofloxacin, orally, and vancomycin, intravenously. Prophylactic antibiotics were given from day 0 until resolution of neutropenia or the appearance of a febrile event. Furthermore, patients in both groups received once a day fluconazole, orally. The primary end-point of our study was the incidence of neutropenic febrile episodes attributed to infection. One hundred and twelve (71.3%) patients developed neutropenic fever, 50 (56.2%) in Group A and 62 (91.2%) in Group B (P < 0.001) with the majority (82%) of patients developing fever of unknown origin. Patients on prophylactic antibiotics had a significantly lower rate of bacteremias (5.6%) than did those randomized to no prophylaxis (29.4%) (P = 0.005) and, when developing neutropenic fever, they had a lower probability of response to first-line empirical antibiotics (P = 0.025). Prophylactic administration of ciprofloxacin and vancomycin reduced the incidence of neutropenic fever in patients receiving HDT with ASCT, however, without affecting the total interval of hospitalization, time to engraftment, or all-cause mortality. Therefore, our results do not support the use of antibiotic prophylaxis for patients undergoing HDT and ASCT.
                © 2010 Wiley-Liss, Inc. Our aim was to compare weekly rufloxacin with daily norfloxacin in the secondary prophylaxis of spontaneous bacterial peritonitis and to examine changes in antibiotic susceptibility in fecal Escherichia coli. The method used was an open randomized clinical trial including 79 patients who received either norfloxacin 400 mg/day or rufloxacin 400 mg/week and followed up for one year. E. coli counts, quinolone susceptibility, and drug concentrations in feces were investigated in 12 patients. Cumulative one-year probability of peritonitis recurrence was 26% for patients on norfloxacin and 36% for those on rufloxacin (P = 0.16). Norfloxacin was more effective in the prevention of peritonitis recurrence due to Enterobacteriaceae (0% vs 22%, P = .01). At the end of follow-up, all 12 patients had E. coli resistant to quinolones in their feces. In conclusion, weekly rufloxacin is not an alternative to daily norfloxacin in the prevention of peritonitis recurrence. The development of quinolone-resistant E. coli in feces may be an important problem in patients on long-term quinolone prophylaxis. In order to evaluate whether the prophylactic use of fluoroquinolones diminishes the incidence of infections and/or mortality during neutropenia, we undertook a prospective, aleatory and controlled study in non-hospitalized adult patients with acute leukemia and chemotherapy-induced neutropenia including twenty five episodes of neutropenia including twenty five episodes of neutropenia which had occurred in 14 patients who were randomly selected either to receive or not quinolones (norfloxacin 800 mg daily or ciprofloxacin 1000 mg daily). Both groups were similar in terms of sex, age, underlying disease, chemotherapy for hematologic malignancy, duration and severity of neutropenia. The use of quinolones was associated with a delay in the fever onset during neutropenia (p = 0.0448), a decrease in the proportion of neutropenic febrile days (p = 0.0456), a decrease of infections caused by gram-negative bacilli (p = 0.037) and an increase of Streptococcus infections (p = 0.0857). There was no significant decrease in mortality, incidence of severe infections, proportion of neutropenic episodes without fever, empiric use of amphotericin B or fungal infections between both groups. The results of this study demonstrate that the prophylactic use of fluoroquinolones does not diminish the infectious morbidity and/or mortality in these patients. We have tested the benefit of prophylaxis by intravenous systemic vancomycin among 59 neutropenic patients in a randomized trial. Vancomycin was delivered on day zero of chemotherapy until the resolution of neutropenia in the prophylactic group (vanco+). Empiric antibiotic therapy (piperacillin, ofloxacine) was identical for all patients. The number of days with fever > 38.5 degrees C was significantly higher in the control (vanco-) group than in the vanco+ group (7.4 vs. 3.7, p < 0.02). Zero gram-positive infections occurred in the vanco+ group versus 9 in the vanco- group (p < 0.002). The mean number of days of empiric antibiotic therapy was reduced in the vanco+ group (11.3 vs. 16.3, p = 0.12). However, no benefit was noted between the two groups with regard to mortality or the severity of the infections. The selection of resistant microorganisms after systemic treatment with vancomycin is of potential risk. Such a prophylactic antibiotic regimen does not seem to be justified. Myringotomy and tube insertion, a common pediatric surgical procedure, is frequently complicated by purulent otorrhea. Many otolaryngologists routinely use topical antibiotics as prophylaxis against post-tympanostomy otorrhea. The aminoglycosides (neomycin sulfate, tobramycin and gentamicin) contained in commonly used topical antibiotics as well as components of the solutions have been shown to be ototoxic in animal studies. Although little reported evidence of ototoxicity in humans exists, sporadic reports of sensorineural hearing loss linked to topical antibiotic use do exist, and the potential for sensorineural hearing loss must be considered. The purpose of this study is to compare the rate of post-tympanostomy otorrhea in a double-blinded randomized trial using either topical Ciprofloxacin, with no reported ototoxicity, or Cortisporin as prophylaxis. One hundred patients (200 ears) between ages 7 months and 11 years with a diagnosis of recurrent otitis media or chronic otitis media undergoing tympanostomy tube insertion were randomized into two equal groups. Three drops of either drop A or B were placed into each ear at the time of tube insertion and then three times daily for 3 days. Patients were examined at 3 weeks and details of otorrhea were obtained. The rate of otorrhea was analyzed using chi-square. The overall rate of otorrhea was 39 ears (19.5%), 17 (17%) ears for the Cortisporin group and 22 (22%) for the Ciprofloxacin group. The difference in rate of otorrhea was not statistically significant (P=0.372, 95% confidence interval equals -6-16%). Our data suggest that topical Cortisporin offers no benefit over Ciprofloxacin for post-operative otorrhea prophylaxis. Therefore we recommend topical quinolone prophylaxis, which should eliminate concerns about ototoxicity, without sacrificing efficacy. The most frequent complication reported for percutaneous endoscopic gastrostomy (PEG) is peristomal wound infection which occurs in as many as 30 % of patients. In the studies published so far, the question of whether antibiotic prophylaxis reduces the incidence of peristomal wound infection has remained controversial. We therefore conducted a prospective, randomized trial to determine whether antibiotic prophylaxis can reduce the incidence of peristomal wound infection associated with PEG.
                During a 2-year-period a total of 347 patients (251 men, 96 women; mean age 60.2+/-5) were included in our study. In all cases, a 9-French gauge Freka gastrostomy tube was inserted using the "pull" technique. The patients were randomly assigned to three different treatment groups (group 1, antibiotic prophylaxis with 2 g cefotaxime; group 2, antibiotic prophylaxis with 4g piperacillin plus 0.5g tazobactam; group 3, no antibiotic prophylaxis). For a period of one week after gastrostomy, the peristomal area was evaluated using a wound score. According to the score, peristomal infections were classified as being of degree I-IV. Infections of up to degree III were regarded as minor, while an infection of degree IV was defined as a severe complication.
                PEG tubes were successfully placed in 336/347 patients (97 %). Of the 336 patients, 29 were excluded because of incomplete follow up (dropout rate 9%). Cases included were: in group 1, n = 101; in group 2, n = 100, and in group 3, n = 106. There was no mortality related to PEG insertion. There were five instances of severe complications (1.6%). Patients who received antibiotic prophylaxis had mean daily combined wound scores that were significantly lower than those of patients without antibiotic prophylaxis (P < 0.01). The control group (no antibiotic prophylaxis) exhibited significantly more peristomal wound infections of degree III (n = 8) than antibiotic prophylaxis group 1 (n = 0, P < 0.001) or antibiotic prophylaxis group 2 (n = 1, P < 0.012). Three patients in group 3 (no antibiotic prophylaxis) and one patient in group 2 developed peritonitis.
                Severe wound infections requiring medical or endoscopic intervention are very rare events after PEG insertion. Antibiotic prophylaxis significantly reduces the risk of peristomal wound infection associated with PEG insertion. Antibiotic prophylaxis, therefore, is to be recommended as a general measure in percutaneous endoscopic gastrostomy. Biliary sepsis represents a major percentage of fatal complications after endoscopic retrograde cholangiopancreatography. We performed a randomized controlled study to investigate the value of antibiotic prophylaxis, and to assess the frequency and source of infectious complications associated with ERCP. Ninety-six patients who underwent 100 endoscopic retrograde cholangiopancreatographies were included in the study. Half of the patients received antibiotic prophylaxis (Cefotaxime 2 g i.v. 15 min before the procedure). Bacteremia was detected in 2% of the patients receiving antibiotic prophylaxis, as compared with 16% (p less than 0.02) in the control group. In order to determine the source of bacteremia, bile samples and irrigation fluid from the suction channel of the endo-scope were obtained for bacteriological evaluation. Several lines of evidence suggested that bacteremia associated with ERCP was essentially caused by mucosal lesions of the oropharynx. Bacteremia was asymptomatic, with the exception of two patients who subsequently developed fever, but recovered rapidly under antibiotic therapy. The frequency of cholangitis following ERCP was not significantly reduced by antibiotic prophylaxis (4% vs. 2%). Recommendations for antibiotic prophylaxis are discussed. 43 patients undergoing treatment for acute leukaemia were randomised to receive either co-trimoxazole alone or co-trimoxazole with framycetin and colistin as antibacterial prophylaxis during periods of neutropenia. There were no significant differences between the two treatment groups in the time before the onset of the first fever, the number of episodes of fever or of septicaemia per patient, the number of neutropenic days during which patients remained afebrile or did not require systemic antibiotics, or the number of resistant organisms acquired. Co-trimoxazole alone is cheaper and easier to take than co-trimoxazole with framycetin and colistin, and it is therefore preferable to the three-drug combination for the prophylaxis of bacterial infection. Despite widespread use of trimethoprim-sulfamethoxazole (TMP-SMZ) for prophylaxis in neutropenic patients, questions remain regarding its efficacy, toxicity, the risk of selection of resistant isolates, and the relation of its activity to selective decolonization vs. the attainment of direct inhibitory levels within blood and tissues. We evaluated the effect of TMP-SMZ (160/800 mg orally every 12 hours) in 42 adult granulocytopenic patients (< 100 absolute neutrophils/mm3, mean duration 13.3 days) undergoing chemotherapy for acute leukemia at 11 participating Veterans Administration Medical Centers in a randomized, double-blind, placebo-controlled trial. No significant differences in survival, frequency of bacteremia, overall infections, use of systemic antimicrobial therapy, or adverse effects, including myelosuppression, were observed between patients receiving TMP-SMZ vs. those receiving placebo. All patients acquired trimethoprim-resistant organisms. Concentrations of trimethoprim in serum were significantly lower before febrile episodes than when patients were afebrile. These results suggest that the purported activity of TMP-SMZ may be related to the serum concentration achieved. Moreover, the results highlight the need for additional study of the value of antibiotic prophylaxis in neutropenic patients. Antibiotic prophylaxis in necrotizing pancreatitis remains controversial. Until now, there have been no double-blind studies dealing with this topic.
                A total sample size of 200 patients was calculated to demonstrate with a power of 90% that antibiotic prophylaxis reduces the proportion of patients with infected pancreatic necrosis from 40% placebo (PLA) to 20% ciprofloxacin/metronidazole (CIP/MET). One hundred fourteen patients with acute pancreatitis in combination with a serum C-reactive protein exceeding 150 mg/L and/or necrosis on contrast-enhanced CT scan were enrolled and received either intravenous CIP (2 x 400 mg/day) + MET (2 x 500 mg/day) or PLA. Study medication was discontinued and switched to open antibiotic treatment when infectious complications, multiple organ failure sepsis, or systemic inflammatory response syndrome (SIRS) occurred. After half of the planned sample size was recruited, an adaptive interim analysis was performed, and recruitment was stopped.
                Fifty-eight patients received CIP/MET and 56 patients PLA. Twenty-eight percent in the CIP/MET group required open antibiotic treatment vs. 46% with PLA. Twelve percent of the CIP/MET group developed infected pancreatic necrosis compared with 9% of the PLA group (P = 0.585). Mortality was 5% in the CIP/MET and 7% in the PLA group. In 76 patients with pancreatic necrosis on contrast-enhanced CT scan, no differences in the rate of infected pancreatic necrosis, systemic complications, or mortality were observed.
                This study detected no benefit of antibiotic prophylaxis with respect to the risk of developing infected pancreatic necrosis. To determine the influence of selective oropharyngeal decontamination (SOD) on the rate of colonization and infection of the respiratory tract in intensive care patients requiring mechanical ventilation for more than 4 days. A financial assessment was also performed.
                Randomized, prospective, controlled study using amphotericin B, colistin sulfate (polymyxin E), and tobramycin applied to the oropharynx and systemic cefotaxime prophylaxis.
                Anesthesiology intensive care unit (ICU) of a 1500-bed hospital.
                A total of 88 patients admitted as emergencies and intubated within less than 24 h were enrolled. Fifty-eight patients received SOD and 30 patients served as controls. Randomization was in the proportion of 2 : 1 study patients to controls.
                Microbiological samples from the oropharynx and other infected sites were taken at the time of admission, then twice a week and after extubation.
                With the use of SOD, colonization was significantly reduced. Furthermore, the infection rate decreased from 77% in the controls to 22% in the study patients. Staphylococcus aureus was the main potential pathogen causing colonization and pneumonia. Number of days in the ICU, duration of ventilation, and mortality were not significantly decreased. The total cost of antibiotics was reduced. Development of resistance was not observed.
                The use of SOD significantly reduced the colonization and pneumonia and the total charge for antibiotics. The length of stay in the ICU, duration of ventilation, and mortality were similar. No resistance was observed. Staphylococcus aureus was selected by SOD in some patients and the clinical relevance needs further observation. Patient enrolment in the 'Non-antibiotic versus antibiotic prophylaxis for recurrent urinary-tract infections' (NAPRUTI) study was started in September 2005. In this study of women with recurrent urinary-tract infections we aim to investigate the effect of 12 months of non-antibiotic prophylaxis in comparison with antibiotic prophylaxis on the rate of recurrence of urinary-tract infections and the development of antibiotic resistance. The study consists of two interlinked, randomised, clinical non-inferiority trials. In one trial, 280 premenopausal women will receive either cranberry capsules (twice daily 500 mg) or standardised antibiotic therapy (once daily 480 mg trimethoprim-sulfamethoxazole). In the other trial, 280 postmenopausal women will receive either oral lactobacilli (twice daily a capsule with > 10(9) colony-forming units of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) or standardised antibiotic therapy. Non-inferiority of non-antibiotic prophylaxis would be attractive given its potential to reduce the prevalence of microbial resistance to antibiotics significantly. This study was carried out on 70 patients with haematological or solid malignancies who were receiving chemotherapy and/or radiotherapy. Forty-one patients were randomly assigned to receive fluconazole, 400 mg/day, while they were neutropenic. Systemic fungal infection developed in four of the 41 patients (9%) receiving prophylaxis in comparison to nine of 29 patients (31%) not receiving prophylaxis. The incidence of systemic fungal infection was significantly different between the groups receiving prophylaxis and those not receiving it (p < 0.05). Fluconazole was found to be effective for preventing systemic fungal infections in neutropenic patients with cancer. The purpose of the study reported here was to investigate the impact of prophylaxis against gram-positive infections in patients undergoing high-dose chemotherapy and autologous bone marrow transplantation in a randomized trial. Forty-three patients undergoing high-dose chemotherapy with autologous bone marrow transplant were enrolled in a nonblinded randomized trial to receive or not to receive prophylaxis for gram-positive infections with 10(6) U of penicillin intravenously (i.v.) every 6 h (q6h) (if penicillin allergic, 750 mg of vancomycin i.v. q12h) in addition to standard antimicrobial prophylaxis with 400 mg of norfloxacin orally three times a day, 200 mg of fluconazole orally once a day, and 5 mg of acyclovir per kg of body weight i.v. q12h. The patients were being treated for germ cell cancer (n = 15), breast cancer (n = 16), Hodgkin's disease (n = 3), non-Hodgkin's lymphoma (n = 4), acute myeloid leukemia (n = 1), acute lymphoblastic leukemia (n = 1), and ovarian cancer (n = 3). The trial was stopped because of excess morbidity in the form of streptococcal septic shock in the group not receiving gram-positive prophylaxis. There were significantly fewer overall infections (10 versus 3; P = 0.016) and streptococcal infections (9 versus 1; P = 0.0078) in the group receiving gram-positive prophylaxis. There were no significant differences in the numbers of deaths, duration of broad-spectrum antibiotics, or incidence of neutropenic fever between the two groups. Prophylaxis for gram-positive infections with penicillin or vancomycin is effective in reducing the incidence of streptococcal infections in patients undergoing high-dose chemotherapy and autologous bone marrow transplant. However, this approach may carry a risk of fostering resistance among streptococci to penicillin or vancomycin. 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. This prospective study was undertaken in an effort to evaluate the role of systemic antibiotic prophylaxis in elective abdominal delivery. Eighty-two patients undergoing elective cesarean section who were not in labor and who did not have ruptured membranes were assigned on a randomized, double-blind basis to receive a three-dose perioperative course of either placebo or ampicillin. Postoperatively, patients were evaluated for the development of infection-related complications. Patients in the antibiotic group experienced less febrile morbidity, had lower fever indices and developed fewer operative-site infections than did patients in the control group. No patient in either group, however, developed a potentially life-threatening infection, and all infected patients responded promptly to parenteral antibiotic therapy. Because of the limited morbidity associated with elective cesarean section in this patient population, it is concluded that the theoretical risks of antibiotic prophylaxis outweigh the expected benefits. Prophylaxis with co-trimoxazole (trimethoprim-sulphamethoxazole) is recommended for people with HIV infection or AIDS but is rarely used in Africa. We assessed the effect of such prophylaxis on morbidity, mortality, CD4-cell count, and viral load among people with HIV infection living in rural Uganda, an area with high rates of bacterial resistance to co-trimoxazole.
                Between April, 2001, and March, 2003, we enrolled, and followed up with weekly home visits, 509 individuals with HIV-1 infection and their 1522 HIV-negative household members. After 5 months of follow-up, HIV-positive participants were offered daily co-trimoxazole prophylaxis (800 mg trimethoprim, 160 mg sulphamethoxazole) and followed up for a further 1.5 years. We assessed rates of malaria, diarrhoea, hospital admission, and death.
                Co-trimoxazole was well tolerated with rare (<2% per person-year) adverse reactions. Even though rates of resistance in diarrhoeal pathogens were high (76%), co-trimoxazole prophylaxis was associated with a 46% reduction in mortality (hazard ratio 0.54 [95% CI 0.35-0.84], p=0.006) and lower rates of malaria (multivariate incidence rate ratio 0.28 [0.19-0.40], p<0.0001), diarrhoea (0.65 [0.53-0.81], p<0.0001), and hospital admission (0.69 [0.48-0.98], p=0.04). The annual rate of decline in CD4-cell count was less during prophylaxis than before (77 vs 203 cells per microL, p<0.0001), and the annual rate of increase in viral load was lower (0.08 vs 0.90 log(10) copies per mL, p=0.01).
                Daily co-trimoxazole prophylaxis was associated with reduced morbidity and mortality and had beneficial effects on CD4-cell count and viral load. Co-trimoxazole prophylaxis is a readily available, effective intervention for people with HIV infection in Africa. The efficacy of a relatively cheap regimen of selective decontamination (SDD) was evaluated in a diverse population of ICU patients. Patients requiring prolonged ICU stay (greater than 5 days) were randomly allocated to a treatment group or control group. Control patients (n = 52) received perioperative antimicrobial prophylaxis and antibiotic treatment was instituted only on sound clinical and bacteriological criteria. Treated patients (n = 48) received gastro-intestinal and oro-pharyngeal decontamination with polymyxin E, norfloxacin, amphotericin B and systemic antibiotic prophylaxis with trimethoprim until decontamination was achieved. The rate of gram-positive infections was not altered by SDD. The incidence of gram-negative respiratory tract, urinary tract and line infections was significantly reduced from 44%, 27% and 15% respectively in the control group to 6%, 4% and 0% in the treatment group. Mortality from nosocomial sepsis and overall mortality were also significantly reduced from 15% and 54% to 0% and 31% respectively. The ICU stay was not reduced by SDD, nor was time on the ventilator or use of therapeutic antibiotics. The reduction in morbidity and mortality was achieved at a relatively low cost. To investigate the impact of isoniazid prophylaxis on mortality and incidence of tuberculosis in children with HIV.
                Two centre prospective double blind placebo controlled trial.
                Children aged > or =8 weeks with HIV.
                Isoniazid or placebo given with co-trimoxazole either daily or three times a week.
                Two tertiary healthcare centres in South Africa.
                Mortality, incidence of tuberculosis, and adverse events.
                Data on 263 children (median age 24.7 months) were available when the data safety monitoring board recommended discontinuing the placebo arm; 132 (50%) were taking isoniazid. Median follow-up was 5.7 (interquartile range 2.0-9.7) months. Mortality was lower in the isoniazid group than in the placebo group (11 (8%) v 21 (16%), hazard ratio 0.46, 95% confidence interval 0.22 to 0.95, P=0.015) by intention to treat analysis. The benefit applied across Centers for Disease Control clinical categories and in all ages. The reduction in mortality was similar in children on three times a week or daily isoniazid. The incidence of tuberculosis was lower in the isoniazid group (5 cases, 3.8%) than in the placebo group (13 cases, 9.9%) (hazard ratio 0.28, 0.10 to 0.78, P=0.005). All cases of tuberculosis confirmed by culture were in children in the placebo group.
                Prophylaxis with isoniazid has an early survival benefit and reduces incidence of tuberculosis in children with HIV. Prophylaxis may offer an effective public health intervention to reduce mortality in such children in settings with a high prevalence of tuberculosis.
                Clinical Trials NCT00330304. 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. A double-blind study was done to test the efficacy of cefoxitin in the prevention of post-cesarean-section infection. The antibiotic was given in three 2-g doses; the initial dose was given immediately after the cord was clamped, and subsequent doses were given four and eight hours later. Cefoxitin prophylaxis significantly reduced morbidity serious enough to require therapeutic antibiotics or to prolong the hospital stay and led to an overall reduction in the anaerobic microbial flora of the endocervix. However, the antibiotic was selective for the overgrowth of enterococci, which were present in nearly half the postoperative cultures of patients who had received the drug. Enterococcal sepsis occurred in one patient, and three other patients had significant bacteriuria and/or urinary tract infections from enterococci. No cefoxitin-resistant strains of Enterobacteriaceae, among species normally sensitive to the drug, were isolated from the stool samples after prophylaxis. The risk of enterococcal colonization and superinfection must be weighted against the benefits of reduction of the infection risk when deciding upon routine antibiotic prophylaxis for cesarean section. 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 This study examined the difference in postoperative bacteriuria in total joint arthroplasty after use of either an indwelling catheter or intermittent catheterization. Previous studies showed a preference for an indwelling catheter over intermittent catheterization to resolve postoperative urinary retention in total joint arthroplasty, but these studies generally used 48 hours of antibiotic prophylaxis. Increasing awareness of costs and bacterial resistance to antibiotics have prompted many centers to reduce prophylaxis to only 1 preoperative dose A prospective, randomized, controlled trial was conducted in primary total hip and primary total knee arthroplasty patients. One dose of cefazolin, 1 g, was administered intravenously immediately preoperatively. Five of 13 (38%) men in the indwelling catheter group and 0 of 14 (0%) men in the intermittent catheterization group developed postoperative bacteriuria (P =.016), and 6 of 33 (18%) women in the indwelling catheter group and 3 of 39 (8%) women in the intermittent catheterization group developed postoperative bacteriuria (not significant). A total of 11 (24%) patients in the indwelling catheter group (n = 46) and 3 (6%) patients in the intermittent catheterization group (n = 53) developed postoperative bacteriuria (P =.018). In this setting with 1-dose antibiotic prophylaxis, intermittent catheterization resulted in a lower incidence of postoperative bacteriuria compared with an indwelling catheter. For men, this difference is significant. In a prospective randomized trial clinical results of orthograde bowel lavage alone (group I) versus combined bowel lavage and parenteral antibiotic prophylaxis with 4 gm Cefoxitin (group II) in two separate dosages (perioperative short-term-prophylaxis) are compared with regard to the reduction of septic complications after colorectal surgery. Septic wound complications were 11/27 = 41% in group I and 2/30 = 7% in group II. The rate of anastomotic leakages was significantly different in the two groups (5/27 in group I, 0 in group II). The monetary costs for given antibiotics and the duration of hospitalization were less in group II. Orthograde bowel lavage alone proved to be of no effect in reducing the rate of septic complications when used without antibiotic perioperative short-term-prophylaxis and therefore cannot be recommended to be used solely. Infection in chemotherapy-induced neutropenia (neutrophils < 500/mm3) is the main cause of death during the treatment of acute leukemia. Antibiotic prophylaxis is a controversial issue to prevent or delay this infection. This study assessed the efficacy of prophylaxis with oral levofloxacin in chemotherapy-induced febrile neutropenic patients. Eighty patients of acute leukemia was randomly assigned to had levofoxacin (500 mg/daily) or placebo from the starting of chemotherapy. Out of 80 patients 53 developed neutropenia and fever. The number of patients with fever (78% vs. 68%), isolation of the pathogenic bacteria (30.43% vs. 16%) was higher and mean starting day of the fever (11.1 vs. 13.2) was shorter in the placebo group than the levofloxacin group. Levofloxacin reduced the bacterial infections and delays the onset of fever in chemotherapy-induced neutropenia especially in short duration (< 7 days). The authors report the results of a randomized, prospective study to assess the effectiveness of perioperative antibiotic prophylaxis in preventing postoperative infections following clean neurosurgical operations. The study group comprised 846 patients treated between October, 1979, and June, 1984. Antibiotics, including cefazolin and gentamicin, were administered only in the immediate preoperative and intraoperative periods. Sixteen patients, none of whom developed infections, were excluded from final statistical analysis because they had inadvertently been entered into the study while failing to meet entry criteria. Fifteen wound infections (3.64%) developed in the group of 412 patients who did not receive antibiotics, whereas only four infections (0.96%) were identified among the 418 patients who received antibiotics. The difference is statistically significant (p = 0.008) and represents a 74% reduction in infection rate with antibiotics. An analysis of subgroups of surgical procedures revealed a dramatic decrease in craniotomy infections from 6.77% to 0% (p = 0.003). Of the four infections that occurred among the antibiotic-treated patients, three were in cases where foreign bodies had been implanted. No complications of antibiotic usage were identified. The rates of infection in areas of the body other than the surgical wound were no different in the antibiotic-treated and nontreated groups. All wound infections in both antibiotic-treated and nontreated patients involved similar types of Gram-positive organisms, suggesting that antibiotic prophylaxis did not produce infections with resistant or unusual organisms. This study, combined with other recently published analyses, suggests that routine perioperative antibiotic prophylaxis can significantly reduce the incidence of postoperative neurosurgical infections. No trials of co-trimoxazole (trimethoprim-sulfamethoxazole) prophylaxis for HIV-infected adults or children have been done in areas with high levels of bacterial resistance to this antibiotic. We aimed to assess the efficacy of daily co-trimoxazole in such an area.
                We did a double-blind randomised placebo-controlled trial in children aged 1-14 years with clinical features of HIV infection in Zambia. Primary outcomes were mortality and adverse events possibly related to treatment. Analysis was by intention to treat.
                In October, 2003, the data and safety monitoring committee recommended early stopping of the trial. 541 children had been randomly assigned; seven were subsequently identified as HIV negative and excluded. After median follow-up of 19 months, 74 (28%) children in the co-trimoxazole group and 112 (42%) in the placebo group had died (hazard ratio [HR] 0.57 [95% CI 0.43-0.77], p=0.0002). This benefit applied in children followed up beyond 12 months (n=320, HR 0.48 [0.27-0.84], test for heterogeneity p=0.60) and across all ages (test for heterogeneity p=0.82) and baseline CD4 counts (test for heterogeneity p=0.36). 16 (6%) children in the co-trimoxazole group had grade 3 or 4 adverse events compared with 18 (7%) in the placebo group. These events included rash (one placebo), and a neutrophil count on one occasion less than 0.5x10(9)/L (16 [6%] co-trimoxazole vs seven [3%] placebo, p=0.06). Pneumocystis carinii was identified by immunofluorescence in only one (placebo) of 73 nasopharyngeal aspirates from children with pneumonia.
                Our results suggest that children of all ages with clinical features of HIV infection should receive co-trimoxazole prophylaxis in resource-poor settings, irrespective of local resistance to this drug. Intravenous administration of a third-generation cephalosporin is optimal antibiotic treatment for spontaneous bacterial peritonitis.
                To compare an intravenous-oral step-down schedule with ciprofloxacin (switch therapy) to intravenous ceftazidime in the treatment of spontaneous bacterial peritonitis, and to evaluate the impact of terlipressin and albumin in the treatment of type 1 hepatorenal syndrome on mortality.
                A total of 116 cirrhotic patients with spontaneous bacterial peritonitis, were randomly given switch therapy with ciprofloxacin (61 patients) or intravenous ceftazidime (55 patients). All patients who developed type 1 hepatorenal syndrome were treated with terlipressin (2-12 mg/day) and albumin (20-40 g/day).
                Resolution of infection was achieved in 46/55 patients treated with ceftazidime (84%) and in 49/61 patients treated with ciprofloxacin (80%, P = N.S.). An intravenous-oral step-down schedule was possible in 50/61 patients (82%) who received ciprofloxacin; 45/61 patients (74%) were discharged before the end of antibiotic treatment and completed it at home. The mean saving per patient due to the reduction of hospital stay in the ciprofloxacin group was 1150 . Type 1 hepatorenal syndrome was treated successfully in 12/19 patients (63%). As a consequence, the in-hospital mortality rate due to infection was 10%.
                Switch therapy with cephalosporin is more cost-effective than intravenous ceftazidime in the treatment of spontaneous bacterial peritonitis in cirrhotic patients who are not on prophylaxis with quinolones. A prospective, double-blind, randomized, placebo-controlled study was performed to evaluate the effect of antibiotic prophylaxis in ear surgery. The present study reports on the results of 750 patients, half of whom received cefuroxime for 1 day, the other half, placebo. All postoperative infections occurring within 2 weeks after the intervention were recorded, together with several preoperative and perioperative parameters. It is concluded that exploratory tympanoplasties (including stapedotomy) and "dry perforation" tympanoplasties should be considered "clean" operations according to the American National Research Council and do not benefit from antibiotic prophylaxis. On the other hand, tympanoplasties performed on draining ears and on ears with cholesteatoma should be considered "dirty" operations for which antibiotic prophylaxis may decrease the postoperative infection rate by factor 3. All postoperative infections healed without sequels under proper treatment, except for three that resulted in graft necrosis--one in the placebo group and two in the cefuroxime group. In consequence, prophylaxis may not be mandatory in the dirty group, although the authors advocate its use for the sake of patient and surgeon comfort. Antibiotic prophylaxis is being commonly used in mesh repair of inguinal hernia but its role has been questioned in a recent Cochrane analysis performed in 2003. Routine use of antibiotic prophylaxis in mesh repair of inguinal hernia can lead to bacterial resistance and increase in cost. In a present double-blind placebo controlled trial involving 120 patients undergoing inguinal hernia repair using prolene hernia system, we did not find any benefit of the routine use of antibiotic prophylaxis in terms of wound infection rate. With the availability of new, broad-spectrum antibiotics, initial therapy with a single agent has become an alternative to classic combinations in the management of febrile, neutropenic cancer patients. The aims of this study were to compare the efficacy of ceftazidime and imipenem as empirical monotherapy of febrile episodes in neutropenic patients, and to examine the frequency with which second-line antibiotics (amikacin, vancomycin, or both) were required. A prospective clinical trial was carried out in a single centre. Eligible patients with solid tumours or lymphoma were randomised to receive monotherapy with ceftazidime or imipenem. In the event of no response, amikacin and/or vancomycin were added in 48-72 h intervals (sequentially, or according to clinical or microbiological data). Efficacy was evaluable for 111 assessable episodes. Median neutrophil count at entry was 100 cells/microliters and median duration of neutropenia was 4 days. Febrile episodes were classified as microbiologically (34%) or clinically documented (42%), and fever of unknown origin (24%). Gram-negative infections (57%) predominated over gram-positive isolates (30%). The overall success rate with monotherapy (69% versus 70%), or with modification (20% versus 23%) were equivalent for ceftazidime and imipenem (P = 0.75). The mortality in this series was 5%. Single-agent therapy with either ceftazidime or imipenem is effective for the empirical treatment of febrile episodes in neutropenic patients with solid tumours. Early addition of amikacin and/or vancomycin resolves most failures of the first step. To determine whether augmented quinolone-based antibacterial prophylaxis in neutropenic patients with cancer reduces infections caused by gram-positive cocci and preserves the protective effect against aerobic gram-negative bacilli.
                Open, randomized, controlled, multicenter clinical trial.
                Centers participating in the National Cancer Institute of Canada Clinical Trials Group.
                111 eligible and evaluable patients hospitalized for severe neutropenia (neutrophil count < 0.5 x 10(9)/L lasting at least 14 days) who were receiving cytotoxic therapy for acute leukemia or bone marrow autografting.
                One of three oral antibacterial prophylactic regimens (norfloxacin, 400 mg every 12 hours; ofloxacin, 400 mg every 12 hours; or ofloxacin, 400 mg, plus rifampin, 300 mg every 12 hours) beginning with cytotoxic therapy.
                Incidence and cause of suspected or proven infection.
                Microbiologically documented overall infection rates for norfloxacin, ofloxacin, and ofloxacin plus rifampin were 47%, 24%, and 9%, respectively (P < 0.001). Corresponding rates were 24%, 13%, and 3%, respectively for staphylococcal bacteremia (P = 0.03) and, 21%, 3%, and 3%, respectively for streptococcal bacteremia (P < 0.01). The pattern of bacteremia suggested that rifampin played a role in suppressing staphylococcal infection. Both ofloxacin alone and ofloxacin plus rifampin had a clinically significant antistreptococcal effect. Aerobic gram-negative rods were cleared from rectal surveillance cultures in all patients after a median of 5.5 days and caused infection in only one patient (0.9%). The reductions in the number of microbiologically documented infections among ofloxacin recipients and ofloxacin plus rifampin recipients were offset by concomitant increases in the number of unexplained fevers (24% of norfloxacin recipients, 53% of ofloxacin recipients, and 49% of ofloxacin plus rifampin recipients; P = 0.02). No statistically significant difference was found among the treatment arms with respect to the overall incidence of febrile neutropenic episodes as defined for this trial (79% for the norfloxacin group, 82% for the ofloxacin group, and 77% for the ofloxacin plus rifampin group).
                Quinolone-based antibacterial chemoprophylaxis protected patients from aerobic gram-negative bacillary infections. Augmentation of the gram-positive activity reduced the incidence of gram-positive infections but did not influence the overall incidence of febrile neutropenic episodes. In a prospective randomized double-blind study of 141 patients referred for reconstructive vascular surgery on the abdominal aorta and the lower extremities, placebo was compared to antibiotic prophylaxis. The prophylaxis group received three doses of a combination of methicillin, 2 g and netilmicin, 200 mg. Antibiotic prophylaxis reduced postoperative wound infections as compared to placebo, i.e. 4/69 (5.8%) vs. 12/72, (16.7%) respectively (P = 0.04). No graft infections occurred. Two cases of postoperative septicaemia were seen in the placebo group, none in the antibiotic group. Among different procedures aortic-femoral bypass operations showed the highest wound infection rates. The two treatment groups were comparable with regard to all other postoperative complications registered, including nephro- and ototoxicity. The antibiotic regimen was considered safe, but had only marginal value as prophylaxis in vascular reconstructive surgery on the abdominal aorta and the lower extremities. 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. We compared the incidence of the Urinary Tract Infection between a single preoperative dose and a three-day antibiotic prophylaxis regimen for transrectal ultrasound guided biopsy in randomized multicenter trial.
                Between February 2006 and December 2007, 322 men who underwent transrectal ultrasound-guided prostate biopsy were included in a multicentre prospective randomised study. Patients received antibiotic prophylaxis by ciprofloxacin orally, either 1g single dose two hours before the biopsy (Group 1: n=139) or a prolonged prophylaxis for three days (Group 2: n=149). Assessment five days before and five days following the biopsy included a clinical examination, biological tests and a self-questionnaire.
                Two patients developed prostatitis, one in each group: 0.75% of the first group, 0.69% of the second. Twelve developed asymptomatic bacteriuria, six in each group: 4.51% of the first group and 4.19% of the second. There was no significant difference between the two groups (Fisher test; p>0.9).
                There was no significant difference between the two antibiotic prophylaxis regimen (one single dose or three days) for patients undergoing TRUS guided biopsies. Therefore, the single preoperative dose should be the preferred option. We prospectively studied the impact of an antibiotic prophylaxis regimen on the incidence of infections, organ dysfunctions, and mortality in a predominantly surgical and trauma intensive care unit (ICU) population. A total of 546 patients were enrolled and stratified according to Acute Physiology and Chronic Health Evaluation (APACHE)-II scores. They were then randomized to receive either 2 x 400 mg of intravenous ciprofloxacin for 4 days, together with a mixture of topical gentamicin and polymyxin applied to the nostrils, mouth, and stomach throughout their ICU stay or to receive intravenous and topical placebo. When receiving prophylaxis, significantly fewer patients acquired infections (p = 0.001, risk ratio [RR], 0.477; 95% confidence interval [CI], 0.367-0.620), especially pneumonias (6 versus 29, p = 0.007), other lower respiratory tract infections (39 versus 70, p = 0.007), bloodstream infections (14 versus 36, p = 0.007), or urinary tract infections (36 versus 60, p = 0.042). Also, significantly fewer patients acquired severe organ dysfunctions (63 versus 96 patients, p = 0.0051; RR, 0.636; 95% CI, 0.463-0.874), especially renal dysfunctions (17 versus 38; p = 0.018). Within 5 days after admission, 24 patients died in each group, whereas 28 patients receiving prophylaxis and 51 receiving placebo died in the ICU thereafter (p = 0.0589; RR, 0.640; 95% CI, 0.402-1.017). The overall ICU mortality was not statistically different (52 versus 75 fatalities), but the mortality was significantly reduced for 237 patients of the midrange stratum with APACHE-II scores of 20-29 on admission (20 versus 38 fatalities, p = 0.0147; RR, 0.508; 95% CI, 0.295-0.875); there was still a favorable trend after 1 year (51 versus 60 fatalities; p = 0.0844; RR, 0.720; 95% CI, 0.496-1.046). Surveillance cultures from tracheobronchial, oropharyngeal, and gastric secretions and from rectal swabs did not show any evidence for the selection of resistant microorganisms in the patients receiving prophylaxis. A controlled study of short-term prophylaxis with cefuroxime was performed on a group of 52 patients with colorectal neoplasms who underwent elective surgery. The patients were divided into two groups, A and B. Group A received the antibiotic immediately before surgery, intraincisionally and immediately after the end of operation; group B was treated only postoperatively. Each patient received a total of 5,250 mg of cefuroxime. Wound sepsis was demonstrated in 11.5% of cases of group A and 23.0% of group B (P less than 0.01); another type of sepsis was observed in 34% of group A and 11.5% of group B (P less than 0.001). There was no difference in the operative mortality in the two groups. To determine the efficacy of long-term prophylaxis with trimethoprim-sulfamethoxazole (TMP-SMZ) for prevention of bacterial infection following renal transplantation, the absorption of TMP-SMZ in transplant patients, the effects of prophylaxis on the microflora, and the cost-benefit of prophylaxis.
                One hundred thirty-two adult patients selected to undergo renal transplantation participated in a randomized, double-blind, placebo-controlled trial.
                Patients randomized to receive TMP-SMZ experienced fewer hospital days with fever (3.3% versus 7.7%, p less than 0.001) and significantly fewer bacterial infections during the transplant hospitalization after removal of a urethral catheter (0.76 versus 1.88 per 100 days, p less than 0.005) and following discharge from the hospital (0.08 versus 0.30 per 100 days, p less than 0.001). During the transplant hospitalization, a daily dose of 320/1,600 mg was highly effective for prophylaxis whereas 160/800 mg daily gave unexpectedly low blood levels and was effective only for prevention of urinary tract infections after catheter removal. Prophylaxis was most effective in prevention of infections of the urinary tract (24 versus 54, p less than 0.005) and bloodstream (one versus nine, p less than 0.01) and infections caused by enteric gram-negative bacilli (four versus 46, p less than 0.001), enterococci (six versus 22, p = 0.006), or Staphylococcus aureus (one versus nine, p = 0.01). Prophylaxis did not prevent urinary tract infection associated with urethral catheters in the early posttransplant period, but after catheter removal, reduced the risk of urinary tract infection threefold (p less than 0.001). No significant differences in colonization by TMP-SMZ-resistant gram-negative bacilli were identified between the two groups; patients given TMP-SMZ were, paradoxically, less likely to become colonized by candida, probably because of less exposure to antibiotics for treatment of infection. Recipients of prophylaxis did not have a higher rate of infection caused by TMP-SMZ-resistant bacteria or Candida; however, their infections were more likely to be caused by resistant bacteria than infections in patients in the placebo group (62% versus 18%, p less than 0.001).
                Prophylaxis with TMP-SMZ, which is well tolerated, significantly reduces the incidence of bacterial infection following renal transplantation, especially infection of the urinary tract and bloodstream, can provide protection against Pneumocystis carinii pneumonia, and is cost-beneficial. Subnormal absorption of TMP-SMZ in the early posttransplant period mandates 320/1,600 mg daily for optimal benefit. Prophylaxis has little discernible effect on the microflora. A study was conducted to assess whether antibiotic prophylaxis in low-risk patients for post-cesarean febrile morbidity was beneficial and cost effective. In a randomized, prospective study, 167 patients received a single, 1-g dose of cefazolin before clamping of the cord, and 140 did not. In the group given prophylaxis the febrile morbidity and postoperative therapeutic antibiotic usage were significantly lower than in the group not given prophylaxis (9% vs. 17.9%, P = .035, and 6.5% vs. 20%, P < .001, respectively). We conclude that single-dose cefazolin prophylaxis is both beneficial and cost effective, even in patients considered to be at low risk of post-cesarean febrile morbidity. Since the value of antibiotic prophylaxis in high-risk patients is accepted, universal antibiotic prophylaxis in every cesarean section case is suggested. Antibiotic prophylaxis is not routinely given for nonimplant, clean operations, although this view has recently been challenged. We have conducted a randomized multicenter, double-blind prospective trial to compare co-amoxiclav with placebo in 619 patients undergoing open groin hernia repair. Altogether 563 (91%) patients fulfilled the protocol; 283 received co-amoxiclav and 280 placebo. There was no difference between the groups in the number of patients receiving local or general anesthetic, the type of repair performed, the use of a subcutaneous fat suture, the type of skin closure used, the use of wound analgesia, or the use of a wound drain. Patients were given a card to return to the hospital in the event of their wound discharging or their needing to see their general practitioner. All patients were reviewed at approximately 6 weeks after operation. Fifty (8.9%) patients sustained a wound infection, 25 in the co-amoxiclav group and 25 in the placebo group. We conclude that antibiotic prophylaxis is of no benefit to patients undergoing open groin hernia repair. 72 patients severely immunocompromised by their underlying disease (marrow aplasia, acute leukaemia, or solid tumour) or by the treatment they were receiving, or both, were randomised to receive antifungal prophylaxis with either oral ketoconazole or conventional doses of oral amphotericin B and nystatin. All patients also had gut decontamination with non-absorbable antibiotics, skin antisepsis, sterile food, and oral cotrimoxazole. Protection against fungal infection was significantly superior with ketaconazole. When patients who had received allogeneic bone-marrow transplant were studied separately, there was no significant difference between the two treatments, probably because there was a fall-off in ketoconazole absorption from the end of the third week after the transplant. However, ketoconazole greatly reduced the likelihood of fungal infection in non-transplant patients. In a randomized controlled trial of the use of a single intravenous dose of gentamicin sulfate and clindamycin phosphate used intraoperatively during emergency abdominal surgery, the overall incidence of postoperative wound infection was reduced from 32.3% to 10.4%. Significant reduction in wound infection occurred in the study group compared with control subjects irrespective of the underlying pathologic lesion. No side effects of the use of antibiotics were noted. The policy of antibiotic prophylaxis in emergency surgery seems to be of particular benefit in elderly patients. 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. The use of antibiotic prophylaxis in open reduction and osteosynthesis of closed hip fractures is still controversial. The aim of this study was to demonstrate the effect of antibiotic prophylaxis in osteosynthesis of these fractures.
                A total of 224 patients operated on between November 1994 and February 1998 in six hospitals by internal fixation for a fresh hip fracture were prospectively and randomly allocated to either a ceftriaxone antibiotic prophylaxis or no prophylaxis group and followed for one year.
                Within 6 weeks after the operation, 2.6% wound infections were recorded in the antibiotic group and 4.7% in the control group. Two (1.9%) of the five infections in the control group were deep infections (both sensitive to ceftriaxone). There were no statistically significant differences between the infection rates in both groups. However, when analyzing all complications recorded within 6 weeks, significantly more complications were found in the control group (p < 0.01). In the multivariate analysis the most important factor predicting postoperative complications was the lack of antibiotic prophylaxis.
                In this study the antibiotic prophylaxis group had significantly less postoperative complications than the control group within 6 weeks after the operation. Pneumonia remains the number one cause of death from infectious diseases in Western Europe and the United States despite the introduction of potent broad-spectrum antibiotics. Granulocyte colony-stimulating factor is considered to improve host defense during infection and may be an effective adjunctive in the treatment of severe infections. We examined the efficacy of granulocyte colony-stimulating factor (r-metHUG-CSF, filgrastim) with regard to clinical response in non-neutropenic ICU patients with nosocomial pneumonia in a prospective, randomized, placebo-controlled trial. 28 patients with newly diagnosed nosocomial pneumonia were randomly assigned to receive 300-480 microg filgrastim or placebo subcutaneously for up to seven days. Study endpoints were death within 15 days, duration of antibiotic therapy and occurrence of serious adverse events (SAE). No significant differences were observed in respect of 15-day (filgrastim1/12 vs. placebo 2/16) or 30-day mortality (1/12 vs.4/16, p=0.355), and length of antibiotic treatment (13.5 vs.11.5 days, p=0.985). Sepsis developed in 1/12 patients in the filgrastim and 6/16 patients in the placebo group (p=0.184). None of the patients developed ARDS or any other SAE related to the study medication. Filgrastim is safe in non-neutropenic ICU patients with nosocomial pneumonia. A benefit of filgrastim with regard to clinical endpoints could not be observed, while there was a trend toward reduced sepsis rate. Ciprofloxacin was compared to ciprofloxacin plus amoxicillin as antibacterial prophylaxis in 53 evaluable patients with neutropenic episodes, because an oral penicillin may help to decrease the incidence of gram-positive infections. The two groups were randomized and evaluated in a number of febrile episodes, in days at fever/at risk, in mean interval of first febrile episode, in duration of antibiotic therapy and in causative organisms in febrile episodes. In conclusion, no significant difference was observed between the two groups in prevention of gram-positive bacteremias. Oral trimethoprim-sulfamethoxazole (Bactrim) plus erythromycin (TMZ-E) was tested versus placebo (P) as prophylaxis for bacterial infection in a randomized, double-blind trial in adult cancer patients receiving cytotoxic chemotherapy expected to result in significant neutropenia. The incidence of adverse reactions attributable to TMZ and/or E was higher in drug-treated episodes (18 of 28 vs 3 of 29 for P, P less than 0.0005) resulting in poorer compliance. The incidence of fever was not significantly different between episodes treated with TMZ-E (18/27) and those treated with P (17/29), nor was there a significant difference in the median interval between the onset of neutropenia and the onset of fever. However, 14 of 18 fevers in TMZ-E recipients were without a documented infectious source compared with only 6 of 17 in P recipients (P less than 0.05). The same patterns were apparent even when episodes in which compliance with the regimen was either excellent or good were considered separately. There was no significant difference in the number of deaths from infection between TMZ-E and P recipients (3/27 vs 1/29). It is concluded that TMZ-E prophylaxis is of no practical benefit, may mask the cause of infection in febrile neutropenic cancer patients, and is associated with substantial toxicity. 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. In a prospective, controlled, double-blind study, 496 patients undergoing abdominal surgery were given antibiotic prophylaxis with a single dose of either ceftriaxone or ampicillin + metronidazole. No significant intergroup difference was found between the respective overall rates of infectious complications (3.2% and 4.9%). Analysis of the microbiologic findings showed incisional wound infections, mainly caused by gram-negative rods, to be more common in the ampicillin-metronidazole group, whereas deep wound infections were more frequent in the ceftriaxone group. It is concluded that ceftriaxone seems to be more efficient than ampicillin-metronidazole as prophylaxis against incisional wound infection, but should preferably be supplemented with an antianaerobic agent to prevent deep wound infections. Antibiotic prophylaxis in elective colonic surgery is of established value and most authors have proposed an association of at least two drugs. We have compared the efficacy of classical prophylaxis (clindamycin and gentamicin, C + G) with that of the single drug cefoxitin (Ce). 101 consecutive patients were covered; 22 had to be excluded and 7 withdrawn after randomization; 72 cases were left for final analysis (C + G 35; Ce 37). Five C + G (14.2%) and 4 Ce cases (10.8%) developed septic complications, possibly caused by opening of the colon (wound infection, anastomotic failure, colocutaneous fistula): this difference is not statistically significant. Episodes of sepsis, urinary tract infection and pneumonia were similar in both groups. Although the number of patients included is relatively small, we conclude that prophylaxis with Ce alone appears to be as effective as double drug prophylaxis with C + G. An open-label randomised clinical trial was designed to compare the efficacy and tolerance of levofloxacin and ciprofloxacin plus phenethicillin for the prevention of bacterial infections in patients with high-risk neutropenia, and to monitor the emergence of antimicrobial resistance. Adult patients (n = 242) scheduled to receive intensive treatment for haematological malignancies were assigned randomly to receive oral prophylaxis with either levofloxacin 500 mg once-daily (n = 122), or ciprofloxacin 500 mg twice-daily plus phenethicillin 250 mg four-times-daily (n = 120). The primary endpoint was failure of prophylaxis, defined as the first occurrence of either the need to change the prophylactic regimen or the initiation of intravenous broad-spectrum antibiotics. This endpoint was observed in 89 (73.0%) of 122 levofloxacin recipients and in 85 (70.8%) of 120 ciprofloxacin plus phenethicillin recipients (RR 1.03, 95% CI 0.88-1.21, p 0.71). No differences were noted between the two groups with respect to secondary outcome measures, including time to endpoint, occurrence of fever, type and number of microbiologically documented infections, and administration of intravenous antibiotics. A questionnaire revealed that levofloxacin was tolerated significantly better than ciprofloxacin plus phenethicillin. Surveillance cultures indicated the emergence of viridans group (VG) streptococci resistant to levofloxacin in 17 (14%) of 122 levofloxacin recipients; in these cases, the prophylactic regimen was adjusted. No bacteraemia with VG streptococci occurred. It was concluded that levofloxacin and ciprofloxacin plus phenethicillin are equally effective in the prevention of bacterial infections in neutropenic patients, but that levofloxacin is tolerated better. Emergence of levofloxacin-resistant VG streptococci is of concern, but appears to be a manageable problem. Interventions directed toward mothers before and during pregnancy and childbirth may help reduce preterm births and stillbirths. Survival of preterm newborns may also be improved with interventions given during these times or soon after birth. This comprehensive review assesses existing interventions for low- and middle-income countries (LMICs).
                Approximately 2,000 intervention studies were systematically evaluated through December 31, 2008. They addressed preterm birth or low birth weight; stillbirth or perinatal mortality; and management of preterm newborns. Out of 82 identified interventions, 49 were relevant to LMICs and had reasonable amounts of evidence, and therefore selected for in-depth reviews. Each was classified and assessed by the quality of available evidence and its potential to treat or prevent preterm birth and stillbirth. Impacts on other maternal, fetal, newborn or child health outcomes were also considered. Assessments were based on an adaptation of the Grades of Recommendation Assessment, Development and Evaluation criteria.
                Most interventions require additional research to improve the quality of evidence. Others had little evidence of benefit and should be discontinued. The following are supported by moderate- to high-quality evidence and strongly recommended for LMICs: Two interventions prevent preterm births--smoking cessation and progesterone. Eight interventions prevent stillbirths--balanced protein energy supplementation, screening and treatment of syphilis, intermittant presumptive treatment for malaria during pregnancy, insecticide-treated mosquito nets, birth preparedness, emergency obstetric care, cesarean section for breech presentation, and elective induction for post-term delivery. Eleven interventions improve survival of preterm newborns--prophylactic steroids in preterm labor, antibiotics for PROM, vitamin K supplementation at delivery, case management of neonatal sepsis and pneumonia, delayed cord clamping, room air (vs. 100% oxygen) for resuscitation, hospital-based kangaroo mother care, early breastfeeding, thermal care, and surfactant therapy and application of continued distending pressure to the lungs for respiratory distress syndrome
                The research paradigm for discovery science and intervention development must be balanced to address prevention as well as improve morbidity and mortality in all settings. This review also reveals significant gaps in current knowledge of interventions spanning the continuum of maternal and fetal outcomes, and the critical need to generate further high-quality evidence for promising interventions. 59 patients who had earlier developed an infection following antineoplastic chemotherapy were randomised to receive either granulocyte colony-stimulating factor (G-CSF) alone or G-CSF+quinolone as prophylaxis during subsequent identical chemotherapy courses. 30 patients received 48 courses of G+CSF, while 29 patients received 44 courses of G-CSF+ofloxacin or ciprofloxacin. The overall infection rate was 23%. Patients with WHO grade IV leukopenia at the onset of prophylactic treatment developed infection in 61% of cases when on G-CSF, but only in 22% when on G-CSF+quinolone (P = 0.002). Patients with initial leukopenia of grade WHO III-I had only a 11% infection rate showing no significant difference between the treatment groups. The median duration of leukopenia < 1 x 10(9)/l was 4 days for patients receiving G-CSF alone and 3.5 days for those receiving additional quinolone. Patients developing infection had grade IV leukopenia for a median of 5 days. Both prophylactic treatments were well tolerated. We conclude that when prophylactic G-CSF is initiated at WHO grade IV leukopenia, addition of an oral quinolone reduces the risk of infection. Infection is still a frequent cause of morbidity and mortality in acute myelogenous leukemia (AML) patients receiving chemotherapy. Recently the main cause of infection has changed from gram-negative to gram-positive bacteria and the resistance to antibiotics has increased. This study aimed to access the effectiveness of antimicrobial prophylaxis (AP) with orally absorbable antibiotics.
                Ninety-five AML patients receiving chemotherapy at Catholic Hemopoietic Stem Cell Transplantation Center from March 1999 to July 1999 were randomly divided into the AP group (250 mg ciprofloxacin twice a day, 150 mg roxithromycin twice a day, 50 mg fluconazole once a day) and the control group for a prospective analysis.
                The incidence of fever was 82.6% in the AP group and 91.6% in the control group (p = 0.15). Though classification and sites of infections showed no difference between the two groups, the catheter associated infection occurred more frequently in the AP group in significance. The time interval between initiation of chemotherapy and onset of fever, white blood cell (WBC) count at the onset of fever, duration of leukopenia (WBC < 1,000/mm3), duration of systemic antibiotic therapy, mortality due to infection and hospitalization period from the data starting chemotherapy showed no differences between the two groups. Infections due to gram negative bacteria decreased to 33.3% in the AP group (vs. 92% in the control group), but infections due to gram positive bacteria increased to 66.7% (vs. 8% in the control group). Gram negative bacteria showed 100% resistance to ciprofloxacin in the AP group and gram-positive bacteria showed 90-100% resistance to erythromycin, regardless of the presence of AP.
                The AP could not reduce the occurrence of infection or infection associated death in AML patients receiving chemotherapy. On considering increased gram-positive infection and resistance to fluoroquinolone and macrolide, routine prescription of AP should be reconsidered. Further studies that assess the effectiveness of AP in other malignancies, aplastic anemia and bone marrow transplantation are required. 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. To determine whether the use of prophylactic antibiotics is effective in the prevention of postoperative wound infection after Lichtenstein open mesh inguinal hernia repair.
                A recent Cochrane meta-analysis (2003) concluded that "antibiotic prophylaxis for elective inguinal hernia repair cannot be firmly recommended or discarded."
                Patients with a primary inguinal hernia scheduled for Lichtenstein repair were randomized to a preoperative single dose of 1.5 g intravenous cephalosporin or a placebo. Patients with recurrent hernias, immunosuppressive diseases, or allergies for the given antibiotic were excluded. Infection was defined using the Centers for Disease Control and Prevention criteria.
                We included 1040 patients in the study between November 1998 and May 2003. According to the intention-to-treat principle, 1008 patients were analyzed. There were 8 infections (1.6%) in the antibiotic prophylaxis group and 9 (1.8%) in the placebo group (P = 0.82). There was 1 deep infection in the antibiotic prophylaxis group and 2 in the placebo group (P = 0.57). Statistical analysis showed an absolute risk reduction of 0.19% (95% confidence interval, -1.78%-1.40%) and a number needed to treat of 520 for the total number of infections. For deep infection, the absolute risk reduction is 0.20% (95% confidence interval, -0.87%-0.48%) with a number needed to treat of 508.
                A low percentage (1.7%) of wound infection after Lichtenstein open mesh inguinal (primary) hernia repair was found, and there was no difference between the antibiotic prophylaxis or placebo group. The results show that, in Lichtenstein inguinal primary hernia repair, antibiotic prophylaxis is not indicated in low-risk patients. We assessed the efficacy of prophylactic antibiotics in children receiving intensive chemotherapy for acute lymphoblastic leukemia. The patients were randomized to receive either trimethoprim-sulfamethoxazole (TMP-SMX) or placebo in a double-blind trial. Thirty patients were evaluated in each group. Children receiving TMP-SMX had fewer episodes of bacteremia (0 vs. 5) and otitis media (3 vs. 18). The geometric mean of the neutrophil nadir was 172 in the TMP-SMX group and 287 in controls. However, no increased delay or dose reduction of chemotherapy was observed in the TMP-SMX treated patients. Five patients who received TMP-SMX developed Gram-negative rods resistant to TMP-SMX on surveillance stool cultures. We conclude that TMP-SMX prophylaxis decreased certain bacterial infections in children with acute lymphoblastic leukemia without causing clinically significant toxicity. The emergence of Gram-negative rods resistant to TMP-SMX in treated patients suggests that TMP-SMX prophylaxis should be restricted to patients who are at high risk for developing a bacterial infection or Pneumocystis carinii pneumonia. In cirrhotic patients with gastrointestinal hemorrhage, bacterial infections are frequent and play a significant role in mortality. We have previously found that patients with a Child-Pugh's class C or a rebleeding are a subgroup of cirrhotic patients with a high risk of infection. The aims of the study were (1) to validate these indicators and (2) to assess the effectiveness of a systemic antibiotic treatment in preventing bacterial infections in bleeding cirrhotics with a high risk of infection. One hundred and nineteen bleeding cirrhotic patients were divided into 3 groups. Patients with a Child-Pugh's class A-B and no rebleeding (i.e., with a low risk of infection) constituted group 1 (n = 55). Patients with a high risk of infection were randomly allocated to serve as controls (group 2, n = 34) or to receive the ciprofloxacin and a combination of amoxicillin and clavulanic acid for 3 days after hemorrhage (group 3, n = 30). This antibiotic prophylaxis was administered first intravenously and then orally when the bleeding was controlled. The study period was defined as 10 days after hemorrhage. Incidence of bacterial infections was significantly higher in patients from group 2 than in patients from group 1 (52.9% vs. 18.2%; P < .001). Moreover, infections were more severe in group 2: a sepsis syndrome or a septic shock developed in 66.7% of infected patients from this group, but in only 20% of infected patients from group 1. Incidence of bacterial infections was much lower in patients from group 3 than in those from group 2 (13.3% vs. 52.9%; P < .001). Eight patients from group 2 (23.5%) and 4 patients from group 3 (13.3%) died during the first four weeks (P-not significant). Septic shock was the cause of death in 3 patients from group 2 and in only 1 patient from group 3. The cost of antibiotic therapy, including antibiotic prophylaxis in group 3, was $208 +/- $63 per patient in group 2 and $167 +/- $42 per patient in group 3 (P < .05). We conclude that (1) patients with a Child-Pugh's class C and/or a rebleeding are a subgroup of cirrhotic patients with a high risk of infection after gastrointestinal hemorrhage and that (2) in these patients, a prophylactic treatment with systemic antibiotics is very effective in preventing bacterial infections. We report the results of a randomized, prospective study devised to assess the effectiveness of perioperative cefamandole prophylaxis on the remote infections rate in neurosurgery. Only two kinds of neurosurgical procedures were studied: shunt placement and craniotomy for brain tumour. In the treated patients cefamandole 1.5 g was given one hour before surgery, then repeated twice eight hourly. When the surgical procedure lasted more than three hours cefamandole 1.5 g was administered throughout the operation. No case of local infection was observed in either group, and the percentage of patients with remote infections was the same in both groups. Leucocytosis and temperature were measured during 15 days following the surgical procedure, and there were no differences between the treated and untreated groups in the evolution of these parameters. This study does not suggest that routine perioperative antibiotic prophylaxis is mandatory in neurosurgery. nan In this study the efficacy of norfloxacin and pefloxacin for the antibacterial prophylaxis of granulocytopenia was compared in cancer patients following cytostatic treatment. A total of 136 patients was randomly selected to receive either norfloxacin or pefloxacin. Nineteen patients remained afebrile in the norfloxacin group compared with thirty one in the pefloxacin group (p = 0.045). Twenty four microbiologically documented infections (twelve with and twelve without bacteraemia) occurred in sixty seven patients taking norfloxacin, and twelve in sixty nine patients taking pefloxacin (five with and seven without bacteraemia) (p = 0.015). Only one infection caused by Gram-negative bacilli was observed in the pefloxacin group compared with seven in the norfloxacin group (p = 0.019). In conclusion, both microbiological and clinical results showed pefloxacin to be a better antibacterial agent than norfloxacin for these patients. To show if surfactant applied in different social-sanitary realities as prophylaxis of respiratory distress syndrome (RDS) is equally useful and able to reduce mortality and incidence of 3-4 radiological grade RDS.
                Two neonatal intensive care units (NICU) in Italy, one NICU in Bulgaria and one NICU in Romania were involved in a randomized controlled clinical trial of prophylaxis vs rescue treatment of RDS. Babies with gestational age 26-30 wks were randomized before birth to prophylaxis in the delivery-room with 200 mg/kg of porcine surfactant (prophylaxis) or to routine assistance (control). Subsequently the babies developing RDS requiring mechanical ventilation and fraction of inspired oxygen (FiO2) > or = 0.4 to maintain PaO2 about 50 mmHg were allowed to be treated rescue with 200 mg/kg of the same surfactant. To reach end-points of reducing mortality by 40% and incidence of radiological grade 3-4 RDS a total number of 174 patients were required.
                Due to logistic, practical and social-political problems the study was interrupted after enrollment of 93 babies (61 in Italy and 32 in Bulgaria). The Romanian centre did not start the study because it was impossible in the scheduled times to equip it for mechanical ventilation of the newborn infants. Analysis done on an intention to treat basis did not show significant reductions of mortality and 3-4 radiological grade RDS, even if there was a trend towards a reduction in the babies given prophylaxis. A significantly lower number of babies given prophylaxis required a subsequent rescue treatment compared to controls (p < 0.001). There was no difference in other complications such as intraventricular haemorrhage, air-leak syndromes and infections between prophylaxis and control infants. As regards pulmonary gas exchange, the PaO2/FiO2 ratio was significantly improved in the babies given prophylaxis for the first 12 hours of life vs the controls.
                Even if the study was terminated before term, the analysis of the data shows that prophylaxis with surfactant is equally effective in different social-clinical conditions to improve pulmonary gas-exchange, especially in the first critical hours of life of premature babies. In a prospective, block-randomized, multicenter study, the safety and efficacy of cefoxitin in preoperative prophylaxis were studied. 1735 patients undergoing appendectomy were evaluable, and half of these patients received 2 g of cefoxitin before undergoing operation. The patients were divided into three groups: patients with a normal appendix, patients with an acutely inflamed appendix, and patients with a gangrenous appendix. The study showed for each group a significant reduction of the incidence of wound infection in patients receiving prophylaxis. However, intra-abdominal abscess formation was not influenced by preoperative antibiotic prophylaxis. Consequently, routine preoperative prophylaxis is recommended before appendectomy. Thirty-three patients completed a prospective double-blind, randomized study to compare the effect of antibiotic prophylaxis or placebo on percutaneous endoscopic gastrostomy-associated wound infections. We define wound infection and arrive at an incidence of 29.4% in patients receiving Cefoxitin antibiotic prophylaxis and 31.2% in patients receiving placebo. Based on these results, we do not recommend antibiotic prophylaxis for percutaneous endoscopic gastrostomy tube placement. This study was conducted to evaluate the effect of antibiotic prophylaxy on decreasing the frequency of postoperative infections after cesarean sections performed in cases with no prior indication of a high risk of infection.
                A prospective randomized study included 269 cesarean sections without a high risk of infection performed in the Maternity and Neonatology Ward of the Sousse Hospital from February 1991 to July 1991. The patients were randomly divided into two groups. One group received an antibiotic prophylactic treatment including cephapirine, gentamicin and metronidazole) and the second group was given no treatment.
                Antibiotic prophylactic therapy led to a reduction of infectious morbidity after cesarean section in patients without high risk o infection from 33% to 11%. A 66% rate of efficacy was observed. In addition, antibiotics given in this context led to substantial cost reduction both by reducing the cost of antibiotics prescribed in the postoperative period and by reducing the number of days of hospitalization, and thus total cost.
                This study demonstrated the effectiveness of antibiotic prophylaxy for cesarean sections in patients without a high risk of infection. Nevertheless, a reevaluation of the antibiotic protocols and a rigorous operative procedure are essential. Misuse of antibiotics in surgical prophylaxis is still quite common. The objectives of this study were to reduce the quantity and improve the quality of surgical prophylaxis and to reduce costs.
                Prospective multi-site study of elective procedures in 13 Dutch hospitals. The quality of prophylaxis was audited before and after an intervention consisting of performance feedback and implementation of national clinical practice guidelines. Process outcome parameters were antibiotic choice, duration, timing, antibiotic volume and costs. Segmented regression analysis was used to estimate the effect size of the intervention. Patient outcome was documented by the incidence of surgical site infections (SSI).
                Before the intervention, 1763 procedures were recorded and 2050 thereafter. Antimicrobial use decreased from 121 to 79 DDD (defined daily doses)/100 procedures and costs reduced by 25% per procedure. After the intervention, antibiotic choice was inappropriate in only 37.5% of the cases instead of in 93.5% expected cases had the intervention not occurred. Prolonged prophylaxis was observed in 31.4% instead of 46.8% expected cases and inappropriate timing in 39.4% instead of the expected 51.8%. Time series analysis showed that all improvements were statistically significant (P < 0.01) and that they could be fully attributed to the intervention. The overall SSI rates before and after intervention were 5.4% (95% CI: 4.3-6.5) and 4.6% (95% CI: 3.6-5.4), respectively.
                The intervention led to improved quality of surgical prophylaxis and to reduced antibiotic use and costs without impairment of patient outcome. This study of 96 women shows that there is doubtful value in routine antibiotic prophylaxis after urodynamic investigation. An unexpectedly high number of women harboured unsuspected infections at the time of evaluation despite prior screening, which suggests prophylaxis would be more useful if given before the tests. Prescribing antibiotics for perioperative prophylaxis in common surgical procedures presents an ideal target for educational intervention. In this situation, antibiotics are often used inappropriately, with consequent excess expense and risk of morbidity. We developed an educational intervention aimed at the choice and appropriate dosing of antibiotics for the prophylaxis of cesarean sections. Person-to-person educational messages targeted at authoritative senior department members were supplemented by brief reminders on a structured antibiotic order form. Time-series analyses were conducted on 34 months of antibiotic use data for 2,783 cesarean sections to estimate the trend of magnitude and significance of discontinuities associated with the start of the program. Prior to the intervention, 95% of sections receiving prophylaxis were given cefoxitin and 3% were given cefazolin. After the intervention, these proportions were reversed, with the shift in use occurring immediately after the intervention (p less than .001). Two years after the intervention, virtually all patients undergoing cesarean sections who receive antibiotic prophylaxis are given cefazolin. Savings from this change alone accounted for over $26,000 each year, or $47.36 per patient-day of prophylaxis. Substantial changes in prescribing practices for routine procedures can be accomplished through the implementation of a coordinated educational program that enlists influential senior staff members in a department in which policy-making is highly centralized, coupled with a structured educational ordering system. Lasting improvements in clinical practices may be brought about by means that are noncoercive, inexpensive and well-accepted by medical staff. Antibiotic prophylaxis is given to children at risk for urinary tract infection. However, evidence concerning its effectiveness in grade I to III vesicoureteral reflux is lacking. The objective of this study was to determine whether antibiotic prophylaxis reduces the incidence of urinary tract infection in young children with low grade vesicoureteral reflux.
                Children 1 month to 3 years old with grade I to III vesicoureteral reflux were assigned randomly to receive daily cotrimoxazole or no treatment, and followed for 18 months. A urinary tract infection constituted an exit criterion. Infection-free survival rates were calculated using the Kaplan-Meier method and compared using the log rank test.
                A total of 225 children were enrolled in the study. Distribution of gender, age at inclusion and reflux grade were similar between the 2 groups. There was no significant difference in the occurrence of urinary tract infection between the 2 groups (17% vs 26%, p = 0.2). However, a significant association was found between treatment and patient gender (p = 0.017). Prophylaxis significantly reduced urinary tract infection in boys (p = 0.013), most notably in boys with grade III vesicoureteral reflux (p = 0.042).
                These data suggest that antibiotic prophylaxis does not reduce the overall incidence of urinary tract infection in children with low grade vesicoureteral reflux. However, such a strategy may prevent further urinary tract infection in boys with grade III reflux. To determine the efficacy of prophylactic ciprofloxacin in preventing urinary tract infections caused by urodynamic study (UDS).
                A total of 210 patients presenting for UDS during a 16-month period were offered enrollment in the study. A clean-catch midstream urine sample was taken 24 hours before and 48 to 72 hours after the procedure and after microscopic examination and culture were done. All patients underwent a standard UDS. The 192 patients who had sterile urine before intervention were included in the study. Randomly, 98 of the 192 patients were orally given 500 mg of ciprofloxacin 1 hour before the urodynamic intervention and 94 were not given anything. The patients who were found to have significant bacteriuria after UDS were followed up and treated properly.
                Eighteen patients (8.6%) who had significant bacteriuria in the urine culture before UDS were excluded from the study. The rate of significant bacteriuria in the urine culture after UDS was 7.3% overall, 1% in the prophylaxis group, and 14% in the controls, a significant difference (P = 0.002). The most common uropathogen was Escherichia coli (57%). Three independent risk factors were identified: not giving antibiotic prophylaxis before UDS; antibiotic use in the preceding month; and the presence of pyuria before UDS.
                Urinary tract infections after UDS decreased from 14% to 1% with a single dose of ciprofloxacin 500 mg orally before UDS. We recommend antibiotic prophylaxis for patients undergoing a UDS. A double-blind placebo-controlled experiment was performed in 100 patients in labor with membrane rupture to determine the bacteriologic effects of antibiotic prophylaxis. Each subject received either 2.0 g cefamandole or placebo after cord clamping and 4 and 8 hours later. The cefamandole group had significantly less endometritis, but did not have significantly fewer major complications. Amniotic fluid cultures of the 2 groups were similar, but uterine lavage cultures of the cefamandole group showed significant increases in enterococci and gram-negative aerobes and decreases in gram-positive anerobes and low virulence organisms (Staphylococcus epidermidis, lactobacilli, and diphtheroids). Although clinical problems did not regularly accompany these changes, it would be foolhardy to ignore them. Thus, when patients develop infection after antibiotic prophylaxis, the physician should check for infection with resistant organisms. 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. Peristomal infection can sometimes complicate percutaneous endoscopic gastrostomy (PEG) placement. Antibiotic prophylaxis has, in some studies, been shown to reduce the incidence. However, the use of prophylaxis varies widely, possibly because the design and findings of the studies have differed, making their relevance to clinical practice difficult to interpret.
                To determine the efficacy of antibiotics, either prophylaxis or concurrent antibiotics at the time of the procedure, in reducing peristomal infection after PEG insertion in the context of a study designed to reflect current practice.
                One hundred and forty-one patients undergoing PEG placement were randomised to group one to receive either a single dose of 750 mg of intravenous cefuroxime (n=50) or placebo (n=51) 30 min before PEG insertion. Forty patients who, for various reasons, were already receiving antibiotics were allocated to group two. The peristomal site was evaluated on day 3, 5 and 7 following insertion. Erythema and exudate were scored on a scale from 0 to 4; induration was scored on a scale of 0-3. A maximum combined score of 8 or higher or the presence of pus was criteria for infection. The primary outcome measure was the occurrence of a peristomal wound infection at any time within one week of PEG insertion.
                Peristomal wound infection was significantly reduced in patients who received antibiotics either as a single dose of cefuroxime [one of 33 (3%)], or in those on antibiotics for prior indications [one of 36 (3%)], compared with placebo [six of 33 (18%)], P=0.04 and 0.03, respectively.
                Antibiotics, either prophylaxis or concurrent, reduce the incidence of peristomal wound infection after PEG placement. A double-blind, placebo-controlled study of mefloquine antimalarial prophylaxis in pregnancy (> 20 weeks of gestation) was conducted in 339 Karen women living in an area of multidrug-resistant malaria transmission on the Thai-Burmese border. Mefloquine gave > or = 86% (95% confidence interval [CI], 59%-94%) protection against Plasmodium falciparum and complete protection against Plasmodium vivax infections. Mefloquine prophylaxis was well tolerated; use of an initial loading dose (10 mg/kg) was associated with transient dizziness, but there were no other significant adverse effects on the mother, the pregnancy, or infant survival or development (followed for 2 years). Falciparum malaria was associated with maternal anemia and a mean reduction in birth weight in gravidae I, II, and III of 225 g (95% CI, 26-423). Maternal anemia at delivery (hematocrit < 30%) was associated with increased infant mortality: 26% versus 15% (relative risk, 1.9; 95% CI, 1.1-3.2). Mefloquine is safe and effective for antimalarial prophylaxis in the second half of pregnancy. We enrolled 60 children with recurrent acute otitis media (AOM) in a study of the effectiveness of antimicrobial prophylaxis. All children were entered into the study following an acute episode of infection treated with amoxicillin (AMX) for 10 days. Following therapy, the children were re-examined, and then randomly assigned to receive either trimethoprim-sulfamethoxazole (TMP-SMX), amoxicillin (AMX) or a placebo (PLA). Twenty children were included in each group. Each drug was administered once a day at bedtime, at 1/3 the therapeutic dose, for 3 months. Children were re-evaluated with pneumootoscopy during episodes of acute illness and with pneumootoscopy and impedance tympanometry (TYMP) at monthly intervals. We observed a significantly increased rate of recurrent AOM in children receiving placebo compared with those who received antibiotics (50% vs. 17% P < 0.005). Both prophylactic antibiotics were equally effective in preventing recurrent AOM (recurrence rate 20% TMP-SMX, 15% AMX). We also observed that recurrences in children receiving placebo occurred earlier in the study period than in those receiving antibiotics. These results suggest that antimicrobial prophylaxis in children with recurrent acute otitis media is effective in reducing subsequent disease. The similar efficacy of both antibiotics tested suggests that the less expensive agent should be used. Caesarean sections are performed with an ever increasing frequency, and their morbidity rate due to infection varies between 35 and 40 per cent. The effectiveness of antibiotic prophylaxis has been demonstrated in caesarean sections with a high risk of infection, but few studies have been devoted to caesarean sections without this high risk. The purpose of our study was to evaluate the effectiveness of antibiotic therapy in this second type of caesarean section since its postoperative infection rate is not negligible (about 25 per cent). We therefore set up a two-centre randomized trial comparing two groups of 133 women without any particular risk of infection. At the moment of umbilical cord clamping, one group received cefotetan 1 g intravenously, while the other group received an intravenous injection of a placebo solution. The postoperative infection rate was 12.5 per cent in the treatment group and 26.9 per cent in the control group (P less than 0.05). The relative risk in the placebo-treated women was 2.15 (95 per cent confidence limits, 1.41 to 3.28). Antibiotic prophylaxis prevented 53.5 per cent of postoperative infections (95 per cent confidence limits, 29 to 69.5 per cent). Moreover, in the treatment group infections were less severe, resulting in a significant decrease in hospital stay and a lower overall cost. We conclude that antibiotic prophylaxis with cefotetan is effective in caesarean sections without a high risk of infection, as it significantly reduces the postoperative morbidity due to infection. The prophylactic use of fluoroquinolones in patients with cancer and neutropenia is controversial and is not a recommended intervention.
                We randomly assigned 760 consecutive adult patients with cancer in whom chemotherapy-induced neutropenia (<1000 neutrophils per cubic millimeter) was expected to occur for more than seven days to receive either oral levofloxacin (500 mg daily) or placebo from the start of chemotherapy until the resolution of neutropenia. Patients were stratified according to their underlying disease (acute leukemia vs. solid tumor or lymphoma).
                An intention-to-treat analysis showed that fever was present for the duration of neutropenia in 65 percent of patients who received levofloxacin prophylaxis, as compared with 85 percent of those receiving placebo (243 of 375 vs. 308 of 363; relative risk, 0.76; absolute difference in risk, -20 percent; 95 percent confidence interval, -26 to -14 percent; P=0.001). The levofloxacin group had a lower rate of microbiologically documented infections (absolute difference in risk, -17 percent; 95 percent confidence interval, -24 to -10 percent; P<0.001), bacteremias (difference in risk, -16 percent; 95 percent confidence interval, -22 to -9 percent; P<0.001), and single-agent gram-negative bacteremias (difference in risk, -7 percent; 95 percent confidence interval, -10 to -2 percent; P<0.01) than did the placebo group. Mortality and tolerability were similar in the two groups. The effects of prophylaxis were also similar between patients with acute leukemia and those with solid tumors or lymphoma.
                Prophylactic treatment with levofloxacin is an effective and well-tolerated way of preventing febrile episodes and other relevant infection-related outcomes in patients with cancer and profound and protracted neutropenia. The long-term effect of this intervention on microbial resistance in the community is not known.
                Copyright 2005 Massachusetts Medical Society. Despite the existence of published recommendations, various studies of antibiotic prophylaxis have reached conflicting conclusions, and controversy exists regarding the role of antibiotic prophylaxis in ERCP. The aim of this study was to analyze the efficacy of the intramuscular administration of clindamicine and gentamicine before ERCP.
                Sixty-one consecutive patients referred for ERCP were prospectively randomized to receive either clindamicine 600mg and gentamicine 80mg, both intramuscularly one hour before the ERCP (group I; 31 patients) or not (group II; 30 patients). Two blood samples were obtained from every patient (just before endoscopy and within 5 minutes of withdrawal of the endoscope) and were incubated for 7 days and examined daily for growth of bacteria. Patients were closely monitored for 7 days after endoscopy to detect the development of infectious complications.
                Only 7 cultures from 7 patients were positive. Four were obtained post-ERCP (two patients in group I and two in group II) and the remaining three before endoscopy. The post-ERCP isolated bacteria were: Streptococcus mitis, Peptoestreptococcus anaerobious, Moraxella spp and Escherichia coli. Two patients, one from each group, developed post-ERCP cholangitis that were solved with medical treatment.
                Our findings indicate that ERCP induce bacteremia in a small group of patients and suggest that prophylactic administration of clindamicine plus gentamicine does not reduce the incidence of bacteremia and cholangitis, and do not support the routine use of prophylactic antibiotics prior to ERCP. 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. In a prospective, randomized trial, prophylactic use of topical antibiotics in addition to systemic prophylaxis was studied in patients undergoing abdominoperineal amputation of the rectum. All patients received gentamicin 80 mg and metronidazole 500 mg intravenously at induction of anesthesia, followed by the same dose 8 hourly for 48 hours. In accordance with the randomization, half of the patients were additionally given gentamicin 160 mg + metronidazole 400 mg topically into the perineal wound at closure. Perineal wound infection appeared in 19 of the 41 patients who received both systemic and topical prophylaxis, and in 18 of the 38 with only systemic antibiotics. Cell-mediated immunity was preoperatively assessed with a skin test (Multitest) in all but three patients. Impairment of cell-mediated immunity was associated with significantly heightened rate of wound infection, and these patients did not benefit from topical antibiotics. This prospective, randomised, controlled trial was performed to evaluate the effectiveness of single-dose antibiotic prophylaxis in decreasing the infectious morbidity following elective caesarean section. Two hundred women undergoing elective caesarean section were randomly assigned to receive either 1.2 g of Augmentin intravenously, or no treatment, just before the start of their caesarean section. The two groups of women were comparable in terms of patient characteristics and operation variables. The overall postoperative morbidity rate was 19% in the Augmentin treated group versus 38% in the group that received no prophylaxis (p < 0.01). The incidence of wound sepsis was 3% in the Augmentin group versus 13% in the control group (p < 0.01). The incidence of febrile morbidity with no identifiable cause was 8% in the Augmentin group versus 18% in the control group (p < 0.05). The duration of hospital stay was significantly shorter in the Augmentin group (p < 0.05). A single-dose of prophylactic Augmentin significantly reduced the postoperative morbidity and duration of hospital stay in women who underwent elective caesarean sections. 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. 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. We performed a randomized, double-blind, placebo-controlled trial of antibiotic prophylaxis before diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP) in 82 uninfected patients with cholestasis due to biliary tree obstruction of single or multiple causes. The patients were assigned to receive piperacillin (4 g) or placebo three times daily; prophylaxis was started just before initial ERCP and was continued until biliary drainage was completely unobstructed (by one or more ERCP procedures); the maximal duration of prophylaxis was 7 days. Nine patients were withdrawn from the study, and five others could not be assessed because of protocol violations. The 68 clinically evaluable patients underwent 81 therapeutic ERCP procedures. Clinical success (defined as an absence of fever, cholangitis, and clinical signs of sepsis during the 48 hours after the last dose of piperacillin or placebo) was documented for 32 (94%) of the 34 patients given piperacillin and for 24 (71%) of the 34 patients given placebo (odds ratio, 6.66; P = .01). Complete biliary drainage influenced clinical outcome favorably (odds ratio, 5.0; P = .02). All seven instances of bacteriologic failure (bacteremia) involved patients in the placebo group (P < .01). We concluded that antimicrobial prophylaxis significantly reduces the incidence of septic complications after therapeutic ERCP among patients presenting with cholestasis. Improving obstetric care in resource-limited countries is a major international health priority.
                To reduce infection rates after cesarean section by optimizing systems of obstetric care for low-income women in Colombia by means of quality improvement methods.
                Multidisciplinary teams in 2 hospitals used simple methods to improve their systems for prescribing and administering perioperative antibiotic prophylaxis. Process indicators were the percentage of women in whom prophylaxis was administered and the percentage of these women in whom it was administered in a timely fashion. The outcome indicator was the surgical site infection rate.
                Before improvement, prophylaxis was administered to 71% of women in hospital A; 24% received prophylaxis in a timely fashion. Corresponding figures in hospital B were 36% and 50%. Systems improvements included implementing protocols to administer prophylaxis to all women and increasing the availability of the antibiotic in the operating room. These improvements were associated with increases in overall and timely administration of prophylaxis (P<.001) in both hospitals by time series analysis, with adjustment for volume and case mix. After improvement, overall and timely administration of prophylaxis was 95% and 96% in hospital A and 89% and 96% in hospital B. In hospital A, the surgical site infection rate decreased immediately after the improvements (P<.001). In hospital B, the infection rate began a downward trend before the improvements that continued after their implementation (P =.04).
                Simple quality improvement methods can be used to optimize obstetric services and improve outcomes of care in resource-limited settings. The objective of this prospective, multicentre trial, carried out at 18 third level hospitals in Italy, was to evaluate efficacy of modified porcine surfactant (Curosurf), administered at birth to prevent the development of respiratory distress syndrome (RDS) in premature infants. 287 babies with a gestational age of 24-30 weeks were randomized to prophylactic treatment with Curosurf (80 mg/ml; dose 20 mg/kg) or to a control group receiving no surfactant treatment in the delivery-room. Babies in both groups were eligible for rescue treatment with surfactant (200 mg/kg) if they developed clinical symptoms of RDS and required mechanical ventilation. The main end-point was to obtain, in the prophylaxis group, a 30% reduction in the incidence of grade 3-4 RDS. Median gestational age was 28 weeks in both groups and mean birth weight 1010 and 1002 g, respectively for prophylaxis and control babies. There was a 32% reduction in the incidence of grade 3-4 RDS in the prophylaxis group (p < 0.05). This was associated with a significant reduction in mean maximum fraction of inspired oxygen (0.57 vs 0.66%; p < 0.01), a decreased incidence of pulmonary interstitial emphysema (7 vs 14%; p < 0.05) and a lowered mortality (21 vs 35%; p < 0.01). Combined unfavourable outcome (mortality + bronchopulmonary dysplasia and/or grade 3-4 intraventricular hemorrhage and/or grade 2-4 retinopathy of prematurity) was significantly lower in the prophylaxis than in the second group (41 vs 58%; p < 0.01). The favourable effects of prophylactic treatment were equally recorded in all the age groups, including the babies with the lowest gestational age (24-25 weeks). Multiple and logistic regression analysis confirmed that high gestational age and surfactant prophylaxis were, independently, associated with a lower degree of RDS (p = 0.0001 and p = 0.0008, respectively) and a lower mortality (p = 0.0001 and p = 0.0045, respectively). We conclude that prophylaxis with modified natural surfactant effectively prevents RDS in newborn babies between 24 and 30 weeks' gestation. To investigate the effectiveness of a single-dose antibiotic regimen for preventing postoperative wound infection, a prospective, randomized double-blind trial was carried out in patients undergoing "clean-contaminated", "contaminated" or "clean" (vascular) surgery. Both elective and emergency operations were included. Single-dose (preoperative) prophylaxis was compared with short-term prophylaxis (1 dose preoperatively and 2 doses postoperatively). The antibiotics were penicillin, tobramycin and metronidazole in various combinations, and comparisons between single-dose and short-term prophylaxis were made with all the regimens. The incidence of wound infection was 5/277 (1.8%) in the short-term group and 9/287 (3.1%) in the single-dose group. The difference was not statistically significant. Nor was statistically significant difference found when the type of operation and the degree of contamination were considered. Single-dose antibiotic prophylaxis thus gave a low incidence of postoperative wound infection, even in "clean-contaminated" or "contaminated" cases. The use of fluoroquinolones as prophylaxis for bacterial infections in patients with chemotherapy induced neutropenia is debatable. The present study was conducted to assess the prophylactic efficacy of fluoroquinolones in adult neutropenic patients with hematologic malignancies.
                For the period 1994 through 2000 a prospective, randomized trial was conducted at the University Clinic of Hematology (Medical University, Plovdiv). Two groups of patients were included--experimental group, consisting of 36 patients with 41 granulocytopenic episodes and a control group of 34 patients with 41 granulocytopenic episodes. Non parametrical and psi methods were used for statistical analysis. Kaplan-Meier test was employed to determine patients' survival rate. Comparison of survival rates between the two groups was performed using the log-rank test.
                A statistically significant difference between the two groups was found in the number of infection-free neutropenic episodes (P < 0.001), in infection-related mortality rate (p = 0.001) and mortality rate within 1 month of the onset of infection (p < 0.001). Difference in long term survival rates was not statistically significant (p > 0.05).
                Prophylaxis with fluoroquinolones reduced the occurrence of infection in adult neutropenic patients without affecting the long-term survival. Moreover, it is especially beneficial for patients with severe neutropenia and during the active phase of the disease. To evaluate the effectiveness of oral amoxicillin/clavulanate (25 mg/kg every 12 h) for prevention of fever and/or infection in neutropenic children with cancer.
                Multicenter, prospective, randomized, double blind placebo-controlled trial.
                In the intention-to-treat analysis, amoxicillin/clavulanate had a 12% benefit increase in terms of reduction in the incidence of febrile or infectious episodes, compared with placebo [44 of 83 (53%) vs.55 of 84 (65%); 95% confidence interval, -28% to +3%; P = 0.101]. This benefit was also associated with a 30% increase in the probability of failure-free survival at Day 15 (P = 0.138). A logistic regression analysis showed the effect of prophylaxis to be relevant, especially in patients with leukemia or lymphoma and in those not receiving hematopoietic growth factors, with 17 and 15% absolute benefit increases (logistic P = 0.014 and 0.034, respectively). Compliance with oral drugs was good, with very few and nonsevere drug-related adverse events.
                In this study amoxicillin/clavulanate was associated with a detectable clinical effect in the reduction of fever and infection in neutropenic children with cancer, especially those with acute leukemia and not receiving growth factors; the study was not powered to demonstrate a statistically significant effect in the overall patient population.
Antibiotic prophylaxis in afebrile neutropenic patients significantly reduced all-cause mortality. In our review, the most significant reduction in mortality was observed in trials assessing prophylaxis with quinolones. The benefits of antibiotic prophylaxis outweighed the harm such as adverse effects and the development of resistance since all-cause mortality was reduced. As most trials in our review were of patients with haematologic cancer, we strongly recommend antibiotic prophylaxis for these patients, preferably with a quinolone. Prophylaxis may also be considered for patients with solid tumours or lymphoma.