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.