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

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.

• Authors: J S Solomkin, S E Wilson, N V Christou, O D Rotstein, E P Dellinger, R S Bennion, R Pak, K Tack
• Journal: Annals of surgery (Ann Surg) Vol. 233 Issue 1 Pg. 79-87 (Jan 2001) ISSN: 0003-4932 [Print] United States
• PMID: 11141229 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

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

Topics

• 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)