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Evaluation of outpatient treatment with ertapenem in a double blind controlled clinical trial of complicated skin/skin structure infections.

Author(s): Gesser RM, McCarroll KA, Woods GL

Affiliation(s): Merck Research Laboratories, West Point, PA, USA. richard_gesser@merck.com

Publication date & source: 2004-01, J Infect., 48(1):32-8.

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

OBJECTIVES: The patient characteristics and the efficacy and safety of ertapenem 1 g once daily vs. piperacillin-tazobactam 13.5 g divided Q6H were examined in patients who received outpatient parenteral antimicrobial therapy (OPAT) during a clinical trial of complicated skin/skin structure infections. METHODS: The population analyzed included 363 patients treated at US sites in a large randomized double-blind study. RESULTS: In this analysis, 146 (40%) patients at 19 (66%) sites were managed by OPAT. A lower proportion of treated patients who received OPAT had severe infection (12% vs. 20%, P=0.03). In evaluable patients managed by OPAT, 45 (83.3%) of 54 treated with ertapenem and 41 (82.0%) of 50 treated with piperacillin-tazobactam were cured at the test of cure assessment 10-21 days post-therapy (OR 1.2 (95% CI, 0.4-3.2), P=0.78). The safety profile of both drugs was generally similar; diarrhoea was the most common adverse event in both groups. CONCLUSIONS: In this trial of complicated skin/skin structure infection, OPAT was commonly used by US investigators. Among patients who received OPAT, ertapenem 1 g daily was as effective as piperacillin-tazobactam 3.375 g Q6H.

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