Efficacy and Safety of Ertapenem Versus Piperacillin-Tazobactam for the Treatment of Intra-Abdominal Infections Requiring Surgical Intervention

• Published in: Journal of gastrointestinal surgery Vol. 10; no. 4; pp. 567 - 574
• Main Authors: Dela Pena, Arturo S., Asperger, Walter, Köckerling, Ferdinand, Raz, Raul, Kafka, Reinhold, Warren, Brian, Shivaprakash, Malathi, Vrijens, France, Giezek, Hilde, DiNubile, Mark J., Chan, Christina Y.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-04-2006; Springer Nature B.V
• Subjects: Abdomen; Abdomen - microbiology; Abscess - drug therapy; Abscess - microbiology; Abscess - surgery; Adolescent; Adult; Aged; Aged, 80 and over; Alanine Transaminase - blood; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Bacterial Infections - drug therapy; Bacterial Infections - surgery; Bacteroides fragilis; Bacteroides Infections - drug therapy; Bacteroides Infections - surgery; beta-Lactams - adverse effects; beta-Lactams - therapeutic use; Diarrhea - chemically induced; Drug therapy; ertapenem; Escherichia coli Infections - drug therapy; Escherichia coli Infections - surgery; Female; Gastrointestinal Diseases - drug therapy; Gastrointestinal Diseases - microbiology; Gastrointestinal Diseases - surgery; Humans; Infections; Intra-abdominal infection; Male; Middle Aged; Penicillanic Acid - adverse effects; Penicillanic Acid - analogs & derivatives; Penicillanic Acid - therapeutic use; Peritonitis - drug therapy; Peritonitis - microbiology; Peritonitis - surgery; Piperacillin - adverse effects; Piperacillin - therapeutic use; piperacillin-tazobactam; Prospective Studies; Treatment Outcome; Intra-abdominal infection; piperacillin-tazobactam; ertapenem
• ISSN: 1091-255X; 1873-4626
• DOI: 10.1016/j.gassur.2005.06.015

Complicated intra-abdominal infections usually mandate prompt surgical intervention supplemented by appropriate antimicrobial therapy. The aim of this study was to demonstrate that ertapenem was not inferior to piperacillin-tazobactam for the treatment of community-acquired intra-abdominal infections. A randomized open-label active-comparator clinical trial was conducted at 48 medical centers on four continents from December 2001 to February 2003. Adult patients with intra-abdominal infections requiring surgery were randomized to receive either ertapenem 1 g daily or piperacillin/tazobactam 13.5 g daily in 3–4 divided doses. The primary analysis of efficacy was the clinical response rate in clinically and microbiologically evaluable patients at the test-of-cure assessment 2 weeks after completion of therapy. All treated patients were included in the safety analysis. Patient demographics, disease characteristics, and treatment duration in both treatment groups were generally similar. The most commonly isolated pathogens at baseline were
E coli (greater than 50% of cases in each group) and
B fragilis (∼9%). Favorable clinical response rates were 107/119 (90%) for ertapenem recipients and 107/114 (94%) for piperacillin/tazobactam recipients. The frequencies of drug-related adverse events, most commonly diarrhea and elevated serum alanine aminotransferase levels, were similar in both treatment groups. Six of 180 ertapenem recipients (3%) and two of 190 piperacillin/tazobactam recipients (1%) had serious drug-related adverse experiences. In this study, ertapenem and piperacillin/tazobactam were comparably safe and effective treatments for adult patients with complicated intra-abdominal infections.