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A Prospective, Double-Blind, Multicenter, Randomized Trial Comparing Ertapenem 3 Vs ≥5 Days in Community-Acquired Intraabdominal Infection

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Journal of Gastrointestinal Surgery Aims and scope

Abstract

Severe secondary peritonitis is diagnosed in only 20–30% of all patients, but studies to date have persisted in using a standard fixed duration of antibiotic therapy. This prospective, double-blind, multicenter, randomized clinical study compared the clinical and bacteriological efficacy and tolerability of ertapenem (1 g/day) 3 days (group I) vs ≥5 days (group II) in 111 patients with localized peritonitis (appendicitis vs non-appendicitis) of mild to moderate severity, requiring surgical intervention. In evaluable patients, the clinical response as primary efficacy outcome were assessed at the test-of-cure 2  and 4 weeks after discontinuation of antibacterial therapy. Ninety patients were evaluable. In groups I and II, 92.9 and 89.6% of patients were cured, respectively; 95.3% in group I and 93.7% in group II showed eradication. These differences were not statistically significant. The most frequent bacteria recovered were Escherichia coli and Bacteroides fragilis. A wound infection developed in seven patients (7.7%) and an intraabdominal infection in one patient (1.1%). There was a low frequency of drug-related clinical or laboratory adverse effects in both groups. Our study demonstrated that, in patients with localized community-acquired intraabdominal infection, a 3-day course of ertapenem had the same clinical and bacteriological efficacy as a standard duration.

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Acknowledgment

This study is supported by a research grant by Merck.

Author information

Authors and Affiliations

  1. Department “Paride Stefanini”, University “La Sapienza”, Policlinico Umberto I. Viale del Policlinico, 00161, Rome, Italy

    Antonio Basoli

  2. Department of Emergency Surgery, University “ La Sapienza”, Rome, Italy

    Piero Chirletti & Alberto Malizia

  3. Department of Emergency Surgery, University of Catania, Catania, Italy

    Ercole Cirino

  4. Department of Emergency Surgery, University of Sassari, Sassari, Italy

    Nicola G. D’Ovidio

  5. Department of Surgery, Catholic University of Rome, Rome, Italy

    Giovanni Battista Doglietto

  6. Department of Surgery, S. Giovanni Bosco Hospital, Naples, Italy

    Domenico Giglio

  7. Department of Surgery, University of Brescia, Brescia, Italy

    Stefano M. Giulini

  8. Department of Emergency Surgery, University of Bologna, Bologna, Italy

    Mario Taffurelli

  9. Merck Sharp and Dohme, Rome, Italy

    Jelena Petrovic & Maurizio Ecari

Authors
  1. Antonio Basoli
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  2. Piero Chirletti
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  3. Ercole Cirino
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  4. Nicola G. D’Ovidio
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  5. Giovanni Battista Doglietto
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  7. Stefano M. Giulini
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  8. Alberto Malizia
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  9. Mario Taffurelli
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  11. Maurizio Ecari
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Consortia

Italian Study Group

Corresponding author

Correspondence to Antonio Basoli.

Additional information

Italian study group: Paolo Mazzocchi, Luigi Solinas, and Fulvio D’Ostuni, Department “Paride Stefanini”, University “La Sapienza”, Rome, Italy; Roberto Caronna, Department of Emergency Surgery, University “ La Sapienza”, Rome, Italy; Antonino Buffone, Department of Emergency Surgery, University of Catania, Catania, Italy; Teresa Verde and Claudia Massaiu, Department of Emergency Surgery, University of Sassari, Sassari, Italy; Dario Di Miceli, Department of Surgery, Catholic University of Rome, Rome, Italy; Salvatore Di Muria, Department of Surgery, S. Giovanni Bosco Hospital, Naples, Italy; Edoardo Cervi, Department of Surgery, University of Brescia, Brescia, Italy; Fausto Catena, Department of Emergency Surgery, University of Bologna, Bologna, Italy; Massimo Coletti and Stefano Scozzafava, Department of Emergency Surgery, University “La Sapienza”, Rome, Italy

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Basoli, A., Chirletti, P., Cirino, E. et al. A Prospective, Double-Blind, Multicenter, Randomized Trial Comparing Ertapenem 3 Vs ≥5 Days in Community-Acquired Intraabdominal Infection. J Gastrointest Surg 12, 592–600 (2008). https://doi.org/10.1007/s11605-007-0277-x

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  • DOI: https://doi.org/10.1007/s11605-007-0277-x

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