J G Jemsek1, F Harrison. 1. Department of Obstetrics and Gynecology Charlotte Memorial Hospital Charlotte NC USA.
Abstract
OBJECTIVE: The safety and efficacy of ampicillin plus sulbactam were compared with those of cefoxitin in the treatment of women with pelvic inflammatory disease (PID). METHODS: This single-site, randomized, prospective, third-party-blinded, comparative, parallel-treatment study enrolled 93 women with a diagnosis of PID. Patients were treated with either ampicillin/sulbactam (2 g/1 g, administered intravenously [IV], every 6 h) or cefoxitin (2 g, administered IV, every 6 h) for a minimum of 12 doses. Patients with cultures positive for Chlamydia trachomatis also receivedconcurrent oral or IV doxycycline (100 mg twice daily). Patients with cultures negative for C. trachomatis received prophylactic oral doxycycline (100 mg twice daily) for 10-14 days after treatment with either ampicillin/sulbactam or cefoxitin was completed. RESULTS:Ninety-three patients were entered in the study: 47 in the ampicillin/sulbactam arm and 46 in the cefoxitin arm. All 93 patients were evaluable for safety; 61 (66%) were evaluable for efficacy. Demographic characteristics were similar for the groups. Of the 27 evaluable ampicillin/sulbactam-treated patients, 67% experienced clinical cure, 30% improved, and 4% failed treatment. Respective values for the 34 cefoxitin-treated patients were 68%, 24%, and 9% (P = 0.67). Pathogens were eradicated in 70% of the women given ampicillin/sulbactam vs. 56% of those who received cefoxitin (P = 0.64). CONCLUSIONS: Overall, ampicillin/sulbactam demonstrated clinical and bacteriologic efficacy at least equivalent to that of cefoxitin in the treatment of women with acute PID. The use of ampicillin/sulbactam for this indication may avoid the complex dosing regimens associated with other treatments.
RCT Entities:
OBJECTIVE: The safety and efficacy of ampicillin plus sulbactam were compared with those of cefoxitin in the treatment of women with pelvic inflammatory disease (PID). METHODS: This single-site, randomized, prospective, third-party-blinded, comparative, parallel-treatment study enrolled 93 women with a diagnosis of PID. Patients were treated with either ampicillin/sulbactam (2 g/1 g, administered intravenously [IV], every 6 h) or cefoxitin (2 g, administered IV, every 6 h) for a minimum of 12 doses. Patients with cultures positive for Chlamydia trachomatis also received concurrent oral or IV doxycycline (100 mg twice daily). Patients with cultures negative for C. trachomatis received prophylactic oral doxycycline (100 mg twice daily) for 10-14 days after treatment with either ampicillin/sulbactam or cefoxitin was completed. RESULTS: Ninety-three patients were entered in the study: 47 in the ampicillin/sulbactam arm and 46 in the cefoxitin arm. All 93 patients were evaluable for safety; 61 (66%) were evaluable for efficacy. Demographic characteristics were similar for the groups. Of the 27 evaluable ampicillin/sulbactam-treated patients, 67% experienced clinical cure, 30% improved, and 4% failed treatment. Respective values for the 34 cefoxitin-treated patients were 68%, 24%, and 9% (P = 0.67). Pathogens were eradicated in 70% of the women given ampicillin/sulbactam vs. 56% of those who received cefoxitin (P = 0.64). CONCLUSIONS: Overall, ampicillin/sulbactam demonstrated clinical and bacteriologic efficacy at least equivalent to that of cefoxitin in the treatment of women with acute PID. The use of ampicillin/sulbactam for this indication may avoid the complex dosing regimens associated with other treatments.