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Original Articles
A Randomized, Controlled, Open, Multi-Center Clinical Trial Comparing Ertapenem versus Ceftriaxone plus Metronidazole for the Treatment of Complicated Intra-abdominal Infections in Adults
Yong Kyun Cho, M.D.1, Jungnam Lee, M.D.1, Seung Ock Suh, M.D.2, Sun-Whe Kim, M.D.3, Jin-Young Jang, M.D.3, Sang Geol Kim, M.D.4, Young Kook Yoon, M.D.4, Woo Jung Lee, M.D.5 and Min Ja Kim, M.D.2
Department of Medicine1, Gachon Medical School, Incheon, Korea Department of Internal Medicine2, Korea University Medical Center, Seoul, Korea Department of Surgery3, Seoul National University College of Medicine, Seoul, Korea 3Department of Surgery4, Kyu
Vol.37 Num.6 (p330~336)
Background:Ertapenem, a novel ?-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.
Keywords : Ertapenem, Clinical efficacy, Safety, Intraabdominal infection