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Int J Surg. 2005;3(1):25-34. doi: 10.1016/j.ijsu.2005.03.010.

Ertapenem versus ceftriaxone and metronidazole as treatment for complicated intra-abdominal infections.

International journal of surgery (London, England)

Narcisco S Navarro, Maria I Campos, Ramon Alvarado, Nora Quintero, Frank J Branicki, Junmin Wei, Malathi Shivaprakash, France Vrijens, Hilde Giezek, Christina Y Chan, Mark J DiNubile,

Affiliations

  1. Jose Reyes Memorial Hospital, Manila, Philippines.

PMID: 17462256 DOI: 10.1016/j.ijsu.2005.03.010

Abstract

BACKGROUND: Prompt surgical intervention supplemented by appropriate antimicrobial therapy is usually required for successful treatment of complicated intra-abdominal infections. The objective of this study was to further evaluate the efficacy and safety of ertapenem relative to ceftriaxone/metronidazole as treatment for complicated intra-abdominal infections.

METHODS: Adult patients with intra-abdominal infections requiring surgery were eligible for this open-label randomized trial comparing ertapenem 1 g daily with ceftriaxone 2 g daily plus metronidazole 30 mg/kg/day. The primary efficacy outcome was the clinical response rate in clinically and microbiologically evaluable participants at the test-of-cure (TOC) visit 2 weeks after discontinuation of therapy. All treated patients were included in the safety analysis.

RESULTS: Participant demographics, disease characteristics, and duration of therapy in both treatment groups were generally similar. Escherichia coli was the most commonly isolated baseline pathogen, recovered in 52% of cases in each treatment group. Favorable clinical responses were achieved at TOC in 143 (96.6%) of 148 ertapenem recipients and in 146 (96.7%) of 151 ceftriaxone/metronidazole recipients. The frequencies of drug-related adverse events, most commonly nausea, diarrhea, vomiting, and elevated platelet count, were generally comparable in both treatment arms. Four ertapenem recipients (1.8%) and one ceftriaxone/metronidazole recipient (0.4%) experienced serious drug-related adverse events.

CONCLUSIONS: In this study, ertapenem and ceftriaxone/metronidazole were comparably effective treatments for adult patients with complicated intra-abdominal infections.

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