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Results of a Clinical Trial of Clinafloxacin Versus Imipenem/Cilastatin for Intraabdominal Infections

Solomkin, Joseph S. MD,*; Wilson, Samuel E. MD,†; Christou, Nicholas V. MD,§; Rotstein, Ori D. MD,§; Dellinger, E. Patchen MD,‡; Bennion, Robert S. MD,¶; Pak, Raphael PharmD,∥; Tack, and Kenneth MD∥

Original Articles

Objective: Clinafloxacin is a novel quinolone with wide activity against the plethora of microorganisms encountered in intraabdominal infections. This trial was performed to examine its clinical efficacy.

Summary Background Data: Clinafloxacin is representative of a new class of quinolones with considerable antimicrobial activity resulting from their mechanisms of action and pharmacodynamics. There is, however, concern about specific potential toxicities, including photosensitivity.

Methods: This prospective, randomized, double-blind trial was conducted to compare clinafloxacin with imipenem/cilastatin as adjuncts in the management of complicated intraabdominal infections.

Results: Five hundred twenty-nine patients were included in the intent-to-treat population, with 312 meeting all criteria for the valid population. Patients with a wide range of infections were enrolled; perforated or abscessed appendicitis was the most common (approximately 50%). One hundred twenty-three of the 150 valid patients treated with clinafloxacin (82%) had successful outcomes, as did 130 of the 162 (80%) treated with imipenem. For the intent-to-treat groups, 219 of 259 patients treated with clinafloxacin (85%) had successful outcomes, as did 219 of 270 patients treated with imipenem/cilastatin (81%). Treatment failure occurred in 39 patients who underwent drainage. There were substantially more gram-negative organisms recovered from the patients with treatment failure who were initially treated with imipenem/cilastatin.

Conclusions: The results of this study clearly demonstrate the safety and efficacy of clinafloxacin in the treatment of a range of intraabdominal infections, and in patients with a broad range of physiologic disturbances.

From the Departments of *Surgery at the University of Cincinnati College of Medicine, Cincinnati, Ohio; University of California–Irvine† School of Medicine, Irvine, California; University of Washington Medical ‡School, Seattle, Washington; University of Toronto§ School of Medicine, Toronto, Canada; McGill University ¶School of Medicine, and the University of California at Los Angeles School of Medicine, Los Angeles, California; and ∥Parke-Davis Pharmaceutical Research, Warner-Lambert Company, Ann Arbor, Michigan

Supported by grants from Parke-Davis Pharmaceutical Research, a division of Warner-Lambert Company.

Correspondence: Joseph S. Solomkin, MD, Department of Surgery, University of Cincinnati, ML #558, Cincinnati, OH 45267-0558. E-mail:

Accepted for publication February 25, 2000.

© 2001 Lippincott Williams & Wilkins, Inc.