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Efficacy of ertapenem in the treatment of serious infections caused by Enterobacteriaceae: analysis of pooled clinical trial data.

Author(s): Gesser RM, McCarroll K, Teppler H, Woods GL

Affiliation(s): Merck Research Laboratories, West Point, PA 19486-0004, USA.

Publication date & source: 2003-05, J Antimicrob Chemother., 51(5):1253-60. Epub 2003 Apr 14.

Publication type: Clinical Trial; Randomized Controlled Trial

OBJECTIVE: The efficacy of ertapenem, 1 g once a day, for treatment of adults with serious infections caused by Enterobacteriaceae was compared with ceftriaxone 1 g once a day [complicated urinary tract infection (CUTI) and community-acquired pneumonia (CAP)] or piperacillin-tazobactam, 3.375 g every 6 h (complicated intra-abdominal, complicated skin/skin structure and acute pelvic infections). PATIENTS AND METHODS: This combined analysis included the subgroup of all 1167 treated patients infected with Enterobacteriaceae from seven randomized double-blind studies. RESULTS: Escherichia coli was the most common pathogen, accounting for 65.3% of all Enterobacteriaceae. Among evaluable patients with deep tissue (intra-abdominal, skin and pelvic) infections, the combined clinical cure rates were 84.8% (223 of 263) for ertapenem and 82.9% (194 of 234) for piperacillin-tazobactam [95% confidence interval (CI) for the difference, adjusting for infection, -4.9% to 8.9%]. Cure rates by infection for ertapenem and piperacillin-tazobactam, respectively, were: intra-abdominal, 85.1% (143 of 168) and 79.9% (119 of 149); pelvic, 86.8% (46 of 53) and 94% (47 of 50); skin/skin structure, 81% (34 of 42) and 80% (28 of 35). Among patients with CUTI, microbiological cure rates were 90.5% (220 of 243) for ertapenem and 92% (196 of 213) for ceftriaxone (95% CI for the difference, -7.1% to 4.1%). In patients with CAP, clinical cure rates were 95% (19 of 20) for ertapenem and 88.9% (16 of 18) for ceftriaxone. CONCLUSION: Ertapenem therapy was as effective as either piperacillin-tazobactam or ceftriaxone for serious infections caused by Enterobacteriaceae.

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