Results of a clinical trial of clinafloxacin versus imipenem/cilastatin for intraabdominal infections

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 considera ble antimicrobial activity resulting from their mechanisms of action and ph armacodynamics. There is, however, concern about specific potential toxicit ies, including photosensitivity. Methods This prospective, randomized, double-blind trial was conducted to compare c linafloxacin with imipenem/cilastatin as adjuncts in the management of comp licated intraabdominal infections. Results Five hundred twenty-nine patients were included in the intent-to-treat popu lation, with 312 meeting all criteria for the valid population. Patients wi th a wide range of infections were enrolled; perforated or abscessed append icitis was the most common (approximately 50%). One hundred twenty-three of the 150 valid patients treated with clinafloxacin (82%) had successful out comes, 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 suc cessful outcomes, as did 219 of 270 patients treated with imipenem/ cilasta tin (81%). Treatment failure occurred in 39 patients who underwent drainage . There were substantially more gramnegative organisms recovered from the p atients with treatment failure who were initially treated with imipenem/cil astatin. Conclusions The results of this study clearly demonstrate the safety and efficacy of cl inafloxacin in the treatment of a range of intraabdominal infections, and i n patients with a broad range of physiologic disturbances.