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Ertapenem once a day versus piperacillin-tazobactam every 6 hours for treatment of acute pelvic infections: a prospective, multicenter, randomized, double-blind study.

Author(s): Roy S, Higareda I, Angel-Muller E, Ismail M, Hague C, Adeyi B, Woods GL, Teppler H, Protocol 023 Study Group

Affiliation(s): Keck School of Medicine at USC, Los Angeles, CA, USA.

Publication date & source: 2003, Infect Dis Obstet Gynecol., 11(1):27-37.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVE: To compare ertapenem therapy with piperacillin-tazobactam therapy for the management of acute pelvic infections. METHODS: In a multicenter, double-blind study, 412 women with acute pelvic infection were assigned to one of two strata, namely obstetric/postpartum infection or gynecologic/postoperative infection, and were then randomized to ertapenem, 1 g once a day, or piperacillin-tazobactam, 3.375 g every 6 hours, both administered intravenously. RESULTS: In total, 163 patients in the ertapenem group and 153 patients in the piperacillin-tazobactam group were clinically evaluable. The median duration of therapy was 4.0 days in both treatment groups. The most common single pathogen was Escherichia coli. At the primary efficacy endpoint 2-4 weeks post therapy, 93.9% of patients who received ertapenem and 91.5% of those who received piperacillin-tazobactam were cured (95% confidence interval for the difference, adjusting for strata, -4% to 8.8%), indicating that cure rates for both treatment groups were equivalent. Cure rates for both treatment groups were also similar when compared by stratum and severity of infection. The frequency and severity of drug-related adverse events were generally similar in both groups. CONCLUSIONS: In this study, ertapenem was as effective as piperacillin-tazobactam for the treatment of acute pelvic infection, was generally well tolerated, and had an overall safety profile similar to that of piperacillin-tazobactam.

Page last updated: 2006-01-31

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