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

Ann Surg. 2001 Jan;233(1):79-87. doi: 10.1097/00000658-200101000-00013.

Abstract

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abdomen*
  • Adult
  • Anti-Infective Agents / therapeutic use*
  • Bacterial Infections / drug therapy*
  • Cilastatin / therapeutic use*
  • Double-Blind Method
  • Female
  • Fluoroquinolones*
  • Humans
  • Imipenem / therapeutic use*
  • Logistic Models
  • Male
  • Middle Aged
  • Prospective Studies
  • Protease Inhibitors / therapeutic use*
  • Thienamycins / therapeutic use*

Substances

  • Anti-Infective Agents
  • Fluoroquinolones
  • Protease Inhibitors
  • Thienamycins
  • Cilastatin
  • Imipenem
  • clinafloxacin