Infect Chemother.
2005 Dec;37(6):330-336.
A Randomized, Controlled, Open, Multi-Center Clinical Trial Comparing Ertapenem versus Ceftriaxone plus Metronidazole for the Treatment of Complicated Intra-abdominal Infections in Adults
- Affiliations
-
- 1Department of Medicine, Gachon Medical School, Incheon, Korea.
- 2Department of Internal Medicine, Korea University Medical Center, Seoul, Korea. macropha@korea.ac.kr
- 3Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.
- 4Department of Surgery, Kyungpook National University Medical College, Daegu, Korea.
- 5Department of Surgery, College of Medicine, Yonsei University, Seoul, Korea.
Abstract
- BACKGROUND
Ertapenem, a novel beta-lactam agent with a wide range of activity, has a pharmacokinetic profile and antimicrobial spectrum that support its potential use as a once-a-day agent for the treatment of common mixed aerobic and anaerobic pathogens encountered in intraabdominal infections.
MATERIALS AND METHODS
The prospective, randomized, controlled, open, and multicenter trial was conducted to compare the clinical efficacy and safety of ertapenem with ceftriaxone plus metronidazole as therapy before or following adequate surgical management of complicated intraabdominal infections.
RESULTS
One hundred sixty-three patients were included in the modified intent-to-treat population, of which 134 were clinically evaluable. Patients with a wide range of infections were enrolled; perforated appendicitis or periappendiceal abscess were most common. As for the modified intent-to-treat groups, 71 of 72 (98.6%) patients treated with ertapenem and 73 of 80 (91.3%) treated with ceftriaxone/metronidazole showed favorable clinical response.
CONCLUSION
In this study, the efficacy of ertapenem was equivalent to ceftriaxone plus metronidazole in the treatment of complicated intraabdominal infections. Ertapenem was generally well tolerated and had a similar safety and tolerability profile compared to ceftriaxone plus metronidazole. The results of this trial suggest that ertapenem could be considered as a useful option that could eliminate the need for combination and/or multi-dosed antibiotic regimens for the empiric treatment of complicated intraabdominal infections.
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