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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: joseph.solomkin@uc.edu

Accepted for publication February 25, 2000.

© 2001 Lippincott Williams & Wilkins, Inc.