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Ertapenem Versus Piperacillin/Tazobactam in the Treatment of Complicated Intraabdominal Infections: Results of a Double-Blind, Randomized Comparative Phase III Trial

Solomkin, Joseph S. MD*; Yellin, Albert E. MD; Rotstein, Ori D. MD; Christou, Nicolas V. MD§; Dellinger, E. Patchen MD; Tellado, Jose M. MD; Malafaia, Osvaldo MD|; Fernandez, Alvaro MD#; Choe, Kyuran A. MD*; Carides, Alexandra PhD**; Satishchandran, Vilas MS**; Teppler, Hedy MD**the Protocol 017 Study Group

doi: 10.1097/01.SLA.0000048551.32606.73
Original Articles

Objective To examine the clinical efficacy and safety of ertapenem, a novel β-lactam agent with wide activity against common pathogens encountered in intraabdominal infection.

Summary Background Data Ertapenem has a pharmacokinetic profile and antimicrobial spectrum that support the potential for use as a once-a-day agent for the treatment of common mixed aerobic and anaerobic infections.

Methods This prospective, randomized, controlled, and double-blind trial was conducted to compare the safety and efficacy of ertapenem with piperacillin/tazobactam as therapy following adequate surgical management of complicated intraabdominal infections.

Results Six hundred thirty-three patients were included in the modified intent-to-treat population, with 396 meeting all criteria for the evaluable population. Patients with a wide range of infections were enrolled; perforated or abscessed appendicitis was most common (approximately 60% in microbiologically evaluable population). A prospective, expert panel review was conducted to assess the adequacy of surgical source control in patients who were failures as a component of evaluability. For the modified intent-to-treat groups, 245 of 311 patients treated with ertapenem (79.3%) were cured, as were 232 of 304 (76.2) treated with piperacillin/tazobactam. One hundred seventy-six of 203 microbiologically evaluable patients treated with ertapenem (86.7%) were cured, as were 157 of the 193 (81.2%) treated with piperacillin/tazobactam.

Conclusions In this study, the efficacy of ertapenem 1 g once a day was equivalent to piperacillin/tazobactam 3.375 g every 6 hours in the treatment of a range of intraabdominal infections. Ertapenem was generally well tolerated and had a similar safety and tolerability profile to piperacillin/tazobactam. A formal process for review of adequacy of source control was found to be of benefit. The results of this trial suggest that ertapenem may be a useful option that could eliminate the need for combination and/or multidosed antibiotic regimens for the empiric treatment of intraabdominal infections.

From the *Department of Surgery, University of Cincinnati College of Medicine, Cincinnati, Ohio;

†Department of Surgery, University of Southern California School of Medicine, Los Angeles, California;

‡Department of Surgery, Univ. of Toronto, Toronto, Ontario, Canada;

§Division of General Surgery, McGill University, Montreal, Quebec, Canada;

¶Division of General Surgery, University of Washington School of Medicine, Seattle, Washington;

∥Hospital Gregorio Marañon, Madrid, Spain;

|Prinicpious de Circugria, Hospital Universitário Evangélico de Curitiba, Curitiba, Brazil;

#Edificio Centro Medico II, Gautemala City, Guatemala;

**Clinical Research-Infectious Diseases, Merck Research Laboratories, West Point, Pennsylvania

Supported by Merck & Co., Inc., West Point, Pennsylvania.

Correspondence: Joseph S. Solomkin, MD, Department of Surgery, University of Cincinnati College of Medicine, 231 Albert B. Sabin Way, Cincinnati, OH 45267-0558.

E-mail: joseph.solomkin@uc.edu

Accepted for publication May 10, 2002.

© 2003 Lippincott Williams & Wilkins, Inc.