Ertapenem versus piperacillin/tazobactam in the treatment of complicated intraabdominal infections: results of a double-blind, randomized comparative phase III trial.

Abstract

OBJECTIVE:

To examine the clinical efficacy and safety of ertapenem, a novel beta-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.

• Authors: Joseph S Solomkin, Albert E Yellin, Ori D Rotstein, Nicolas V Christou, E Patchen Dellinger, Jose M Tellado, Osvaldo Malafaia, Alvaro Fernandez, Kyuran A Choe, Alexandra Carides, Vilas Satishchandran, Hedy Teppler, Protocol 017 Study Group
• Journal: Annals of surgery (Ann Surg) Vol. 237 Issue 2 Pg. 235-45 (Feb 2003) ISSN: 0003-4932 [Print] United States
• PMID: 12560782 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Lactams
• beta-Lactams
• Piperacillin, Tazobactam Drug Combination
• Penicillanic Acid
• Ertapenem
• Piperacillin

Topics

• Abdominal Abscess (drug therapy, etiology, microbiology, surgery)
• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Anti-Bacterial Agents (therapeutic use)
• Digestive System Surgical Procedures (methods, standards)
• Double-Blind Method
• Drug Therapy, Combination (therapeutic use)
• Ertapenem
• Female
• Gram-Negative Bacterial Infections (complications, drug therapy, microbiology, surgery)
• Gram-Positive Bacterial Infections (complications, drug therapy, microbiology, surgery)
• Hospitalization
• Humans
• Lactams
• Male
• Middle Aged
• Penicillanic Acid (analogs & derivatives, therapeutic use)
• Peritonitis (drug therapy, etiology, microbiology, surgery)
• Piperacillin (therapeutic use)
• Piperacillin, Tazobactam Drug Combination
• Prospective Studies
• Research Design (standards)
• Treatment Outcome
• beta-Lactams