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Comparison of Intravenous/Oral Ciprofloxacin Plus Metronidazole Versus Piperacillin/Tazobactam in the Treatment of Complicated Intraabdominal Infections

Cohn, Stephen M. MD*; Lipsett, Pamela A. MD†; Buchman, Timothy G. MD‡; Cheadle, William G. MD§; Milsom, Jeffery W. MD∥; O’Marro, Steven MD¶; Yellin, Albert E. MD#; Jungerwirth, Steven MD**; Rochefort, Estela V.**; Haverstock, Daniel C. PhD**; Kowalsky, Steven F. PharmD**; the Intra-Abdominal Study Group

Original Articles

Objective: To compare the safety and efficacy of intravenous (IV) ciprofloxacin plus IV metronidazole (CIP+MET) with that of IV piperacillin/tazobactam (PIP/TAZO) in adults with complicated intraabdominal infections, and to compare the efficacy of sequential IV-to-oral CIP+MET therapy with that of the IV CIP-only regimen.

Summary Background Data: Treatment of intraabdominal infections remains a challenge, mainly because of their polymicrobial etiology and attendant death and complications. Antimicrobial regimens using sequential IV-to-oral therapy may reduce the length of hospital stay.

Methods: In this multicenter, randomized, double-blind trial involving 459 patients, clinically improved IV-treated patients were switched to oral therapy after 48 hours. Overall clinical response was the primary efficacy measurement.

Results: A total of 282 patients (151 CIP+MET, 131 PIP/TAZO) were valid for efficacy. Of these patients, 64% CIP+MET and 57% PIP/TAZO patients were considered candidates for oral therapy. Patients had a mean APACHE II score of 9.6. The most common diagnoses were appendicitis (33%), other intraabdominal infection (29%), and abscess (25%). Overall clinical resolution rates were statistically superior for CIP+MET (74%) compared with PIP/TAZO (63%). Corresponding rates in the subgroup suitable for oral therapy were 85% for CIP+MET and 70% for PIP/TAZO. Postsurgical wound infection rates were significantly lower in CIP+MET (11%) versus PIP/TAZO patients (19%). Mean length of stay was 14 days for CIP+MET and 17 days for PIP/TAZO patients.

Conclusion: CIP+MET, initially administered IV and followed by CIP+MET oral therapy, was clinically more effective than IV PIP/TAZO for the treatment of patients with complicated intraabdominal infections.

From the *University of Miami School of Medicine, Miami, Florida; †Johns Hopkins Hospital, Baltimore, Maryland; ‡Washington University School of Medicine, St. Louis, Missouri; §University of Louisville, Louisville, Kentucky; ∥Cleveland Clinic Foundation, Cleveland, Ohio; ¶St. Johns Hospital, Springfield, Illinois; #LAC and USC Medical Centers, Los Angeles, California; and the **Bayer Corporation, West Haven, Connecticut

Correspondence: Stephen M. Cohn, MD, Dept. of Surgery, Division of Trauma/Surgical Critical Care (D-40), University of Miami School of Medicine, P.O. Box 01690, Miami, FL 33101.

Presented in part at the 38th Interscience Conference on Antimicrobial Agents and Chemotherapy, September 24–27, 1998, San Diego, CA.

Supported by a research grant from Bayer Corp., Pharmaceutical Division, West Haven, CT.

Dr. Jungerwirth is currently with Procter & Gamble Pharmaceuticals, Cincinnati, OH.

E-mail: stephen.cohn@miami.edu

Accepted for publication September 24, 1999.

© 2000 Lippincott Williams & Wilkins, Inc.