Ertapenem versus piperacillin/tazobactam in the treatment of complicated XXXX : results of a double-blind, randomized comparative phase III trial.

@entity1 @entity281 @entity1320 @entity698
OBJECTIVE: To examine the clinical efficacy and safety of ertapenem, a novel beta-lactam agent with wide activity against common pathogens encountered in @entity1320 . SUMMARY BACKGROUND DATA: Ertapenem has a pharmacokinetic profile and antimicrobial spectrum that support the potential for use as a once-a-day agent for the treatment of common mixed aerobic and anaerobic @entity281 . METHODS This prospective, randomized, controlled, and double-blind trial was conducted to compare the safety and efficacy of ertapenem with piperacillin/tazobactam as therapy following adequate surgical management of complicated @entity1320 . RESULTS: Six hundred thirty-three @entity1 were included in the modified intent-to-treat population, with 396 meeting all criteria for the evaluable population. @entity1 with a wide range of @entity281 were enrolled; perforated or @entity698 was most common (approximately 60% in microbiologically evaluable population). A prospective, expert panel review was conducted to assess the adequacy of surgical source control in @entity1 who were failures as a component of evaluability. For the modified intent-to-treat groups, 245 of 311 @entity1 treated with ertapenem (79.3%) were cured, as were 232 of 304 (76.2) treated with piperacillin/tazobactam. One hundred seventy-six of 203 microbiologically evaluable @entity1 treated with ertapenem (86.7%) were cured, as were 157 of the 193 (81.2%) treated with piperacillin/tazobactam. CONCLUSIONS: In this study, the efficacy of ertapenem 1 g once a day was equivalent to piperacillin/tazobactam 3.375 g every 6 hours in the treatment of a range of @entity1320 . Ertapenem was generally well tolerated and had a similar safety and tolerability profile to piperacillin/tazobactam. A formal process for review of adequacy of source control was found to be of benefit. The results of this trial suggest that ertapenem may be a useful option that could eliminate the need for combination and/or multidosed antibiotic regimens for the empiric treatment of @entity1320 .
