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. (C) 2003 The British Infection Society. Published by Elsevier Ltd. All rights reserved.
机构:
Duke Univ, Med Ctr, Duke Clin Res Inst, Div Infect Dis, Durham, NC 27715 USADuke Univ, Med Ctr, Duke Clin Res Inst, Div Infect Dis, Durham, NC 27715 USA
Corey, G. Ralph
Wilcox, Mark H.
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Leeds Teaching Hosp, Dept Microbiol, Leeds, W Yorkshire, England
Univ Leeds, Leeds, W Yorkshire, EnglandDuke Univ, Med Ctr, Duke Clin Res Inst, Div Infect Dis, Durham, NC 27715 USA
Wilcox, Mark H.
Talbot, George H.
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Talbot Advisors LLC, Wayne, PA USADuke Univ, Med Ctr, Duke Clin Res Inst, Div Infect Dis, Durham, NC 27715 USA
Talbot, George H.
Thye, Dirk
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Cerexa Inc, Oakland, CA USADuke Univ, Med Ctr, Duke Clin Res Inst, Div Infect Dis, Durham, NC 27715 USA
Thye, Dirk
Friedland, David
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Cerexa Inc, Oakland, CA USADuke Univ, Med Ctr, Duke Clin Res Inst, Div Infect Dis, Durham, NC 27715 USA
Friedland, David
Baculik, Tanya
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Cerexa Inc, Oakland, CA USADuke Univ, Med Ctr, Duke Clin Res Inst, Div Infect Dis, Durham, NC 27715 USA