Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Prevention of IUD-related pelvic infection: the efficacy of prophylactic doxycycline at IUD insertion. Effect of prophylactic antibiotics on morbidity associated with IUD insertion: results of a pilot randomized controlled trial. IUD Study Group. Pelvic inflammatory disease and intrauterine devices: prophylactic antibiotics to reduce febrile complications. Postpartum insertion of modified intrauterine devices. The role of antibiotic prophylaxis in mesh repair of primary inguinal hernias using prolene hernia system: a randomized prospective double-blind control trial. Contraceptive efficacy of the Copper T 380A and Copper T 200 intrauterine devices: results from a comparative clinical trial in six developing countries. Antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG): a prospective randomized clinical trial. Preventing IUCD-related pelvic infection: the efficacy of prophylactic doxycycline at insertion. A comparative trial of a single dose of azithromycin versus doxycycline for the treatment of mild scrub typhus. Short-term systemic prophylaxis with cefoxitin and doxycycline in colorectal surgery. A prospective, randomized study.
The value of antibiotic prophylaxis before insertion of an intrauterine device (IUD) remains uncertain. We undertook a triple-masked, randomised, placebo-controlled trial to find out whether such prophylaxis reduces the rate of IUD removal within 90 days.
                11 clinic sites in southern California enrolled women who requested IUD insertion and were at low risk of sexually transmitted infection according to self-reported medical history. We randomly assigned 1985 participants either 500 mg azithromycin or placebo capsules of identical appearance taken about 1 h before insertion of a Copper T 380A IUD. 118 women did not have an IUD inserted. We followed up 1833 of the remaining 1867 (98%) participants for at least 90 days after insertion.
                The rate of IUD removal for any reason other than partial expulsion was 3.8% (35/918) in the antibiotic group and 3.4% (31/915) in the placebo group (relative risk 1.1 [95% CI 0.7-1.8]). The two treatment groups sought medical attention with equal frequency (mean 38 visits per 100 women). During the 90 days after IUD insertion, only one woman from each assignment group had salpingitis, as defined by established criteria.
                Prophylaxis with azithromycin did not affect the likelihood that a woman would retain her IUD at 90 days or the frequency of postinsertion medical attention. In appropriately screened women, the risk of upper-genital-tract infection is negligible after IUD insertion, with or without the administration of prophylactic antibiotics. It is believed that much of the small increased risk for developing pelvic inflammatory disease (PID) associated with the use of an intrauterine device (IUD) appears to be caused by bacterial contamination of the endometrial cavity at the time of insertion. Previous research suggests that use of prophylactic antibiotics immediately prior to IUD insertion may reduce the risk of developing PID. This paper presents results from a randomized clinical trial of 1485 women in Ibadan, Nigeria evaluating the effectiveness of 200 mg of doxycycline (versus placebo) given orally at the time of IUD insertion in reducing the incidence of PID during the first three months of IUD use. Rate of PID infection in the doxycycline-treated group was not significantly lower than that in the placebo-treated group. The rate of unscheduled IUD-related visits to the clinic also was not significantly lower among the doxycycline-treated group. However, the incidence of PID was low (21 cases) for both study groups. Aseptic conditions during IUD insertion, follow-up visits with short intervals to monitor health, and treatment of opportunistic infections may have reduced the potential of PID within this population. The efficacy of administering an antibiotic prior to IUD insertion to reduce the risk of introducing an upper genital tract infection during the procedure has not yet been established. Two double-blind randomized studies conducted in Africa comparing a 200 mg prophylactic dose of doxycycline with a placebo did not conclusively identify a reduced risk of post-insertion pelvic inflammatory disease (PID). A clinical trial of comparable design is currently under way in the US. This multi-site trial will evaluate whether use of an antibiotic prior to insertion reduces the risk of IUD removal for all medical reasons, including upper genital tract infection, within the first three months after insertion. This paper reports on the pilot phase of this study, which was designed to test the protocols and data collection instruments in advance of the full-scale clinical trial. A total of 447 prospective IUD (TCu-380A) users were randomly assigned to receive either a 200 mg dose of doxycycline or a placebo one hour before IUD insertion. 3.6% (8/219) of participants who received the antibiotic had the device removed for medical reasons (infection, bleeding, cramping, etc.) within three months post-insertion compared to 4.5% (10/223) of participants who received the placebo. This reduction in the removal rate was not statistically significant given the limited size of the pilot study (RR = 0.81; 95% CI 0.28-2.29). Only two subjects, one from each treatment group, met the diagnostic criteria for acute PID. The overall three-month retention rate was 91.8% for the antibiotic group and 89.7% for the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS) In the present study, we tried to determine whether IUD insertion related PID and febrile complications could be prevented by prophylactic use of antibiotics. We studied 300 patients who were admitted to our family planning clinic for IUD contraception. Of these, 150 patients received prophylactic Doxycycline (group 1) and the second 150 received no therapy (group 2). Five cases experienced fever with or without leucocytosis and none required hospitalization. PID was observed in one woman in each group. Positive culture (gonorrhea) was obtained in one woman who was then treated by relevant antibiotics; the other woman required hospitalization for two days. The overall infection rates for group 1 and 2 were 2.1% and 2.9%, respectively and this difference was not significant. The incidence of PID infection and febrile complications was found to be very low for both groups when compared to other studies, suggesting that aseptic conditions with proper insertion reduce the risk of infection. The immediate postpartum insertion of standard intrauterine devices (IUDs) and those specially modified for postpartum use was evaluated in a multicenter clinical trial. The immediate postpartum insertion of IUDs was not associated with any increased risk of perforation or infection, although expulsion rates were higher than with interval insertions. The expulsion rate varied widely between centers using similar devices, suggesting that training in insertion is essential. Postpartum IUD insertions can be a practical contraceptive option for patients and providers of medical services. 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. The clinical performance of the Copper T 380A (TCu 380A) and the Copper T 200 (TCu 200) intrauterine devices (IUDs) was evaluated for 12 months in a group of women who had one of the two IUDs inserted. Results are from a multicenter randomized clinical trial at one site in each of six developing countries. The pregnancy rate with the TCu 380A IUD was significantly lower than the pregnancy rate with the TCu 200 IUD at 12 months (0.5 and 2.6 per 100 women, respectively, p < 0.01). No statistically significant differences between the two study IUDs were found with regards to expulsion or removals due to bleeding/pain, personal, medical, or planned pregnancy. The TCu 380A IUD did not have a disproportionately higher incidence of side effects such as intermenstrual bleeding or pain, inflammations or infections, or insertion-related events compared to the TCu 200 IUD. TCu 380A IUD users, however, were significantly more likely to report increased dysmenorrhea than were TCu 200 IUD users. The performance of the TCu 380A IUD in preventing pregnancy during this trial indicates that this IUD may be a better option than the TCu 200 IUD for women wishing to practice effective, long-term, reversible birth control without having to resort to hormonal methods. 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. Most of the small increased risk in pelvic inflammatory disease (PID) associated with the intrauterine contraceptive device (IUCD) appears to be caused by bacterial contamination of the endometrial cavity at the time of insertion. This randomized clinical trial of 1813 women in Nairobi, Kenya, assessed the effectiveness of 200 mg of doxycycline given orally at the time of insertion in reducing the occurrence of PID. The rate of this infection in the doxycycline-treated group was 31% lower than that in the placebo-treated group (1.3 and 1.9%, respectively; RR 0.69; 95% CI 0.32 to 1.5). The rate of an unplanned IUCD-related visit to the clinic was also 31% lower in the doxycycline-treated group (RR 0.69; 95% CI 0.52 to 0.91). Although the significance level (P = 0.17) for the reduction is PID does not meet the conventional standard of 0.05, the results may be suggestive of an effect. Moreover, the reduction in IUCD-related visits (P = 0.004) not only represents an important decrease in morbidity but also substantiates the reduction found for PID. Further studies are needed to corroborate these results. Consideration should be given to the prophylactic use of doxycycline at the time of IUCD insertion as an approach to preventing PID and other IUCD-related morbidity. Scrub typhus is one of the most important endemic infections in the Asia-Pacific region. Although tetracyclines or chloramphenicol are the recommended drugs of choice for the treatment of scrub typhus, reports of doxycycline-resistant strains have prompted a search for alternative treatments.
                We conducted a prospective, open-label, randomized trial from September 2002 through November 2003 to compare azithromycin with doxycycline for the treatment of mild scrub typhus. The time to defervescence was assessed to compare the efficacy of the 2 treatment regimens.
                A total of 93 patients were randomly assigned to receive either a single 500-mg dose of azithromycin or a 1-week course of daily oral 200-mg dose of doxycycline. Cure was achieved in 47 (100%) of 47 patients in the azithromycin-treated group and in 43 (93.5%) of 46 patients in the doxycycline-treated group (P=.117). The median time to defervescence was 21 h for the azithromycin-treated group and 29 h for the doxycycline-treated group (P=.097). There were no serious adverse events during the study. No relapses occurred in either group during a 1-month follow-up period.
                The single 500-mg dose of azithromycin was as effective as the 1-week course of daily 200-mg doses of doxycycline for the treatment of mild scrub typhus acquired in South Korea. The efficacy of cefoxitin or doxycycline as antibiotic prophylaxis in colorectal surgery was compared in 102 elective operations. Both drugs were used perioperatively only. Cefoxitin was used in 55 cases and doxycycline in 47. Ten patients in the cefoxitin group and 4 in doxycycline group had wound infections. Three intraabdominal abscesses were seen, one after cefoxitin and two after doxycycline prophylaxis. All three were due to anastomotic leakage. Bacteriologic studies revealed no negative ecologic effects of prophylaxis. The short-term prophylaxis used did protect against serious infectious complications. The extended spectrum of cefoxitin provided no added benefit in prophylaxis. Patients with inflammatory bowel disease treated preoperatively with salicylazosulfapyridine run a greater risk of postoperative infection in spite of the prophylaxis.
Use of either doxycycline 200 mg or azithromycin 500 mg by mouth before IUD insertion confers little benefit. While the reduction in unscheduled visits to the provider was marginally significant, the cost-effectiveness of routine prophylaxis remains questionable. A uniform finding in these trials was the low risk of IUD-associated infection, with or without use of antibiotic prophylaxis.