A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections

Summary

Intra-abdominal infections are often polymicrobial, and include aerobic as well as anaerobic bacteria. Antibiotics used in intra-abdominal infections should aim to cover organisms such as Enterobacteriaceae and Bacteroides fragilis, which are the commonest organisms known to cause such infections. Combinations of a third-generation cephalosporin, an aminoglycoside and metronidazole are often used to treat such infections in surgical settings. An alternative to such combinations is the use of a beta lactam - beta lactamase inhibitor combination. Magnex (cefoperazone- sulbactam) is one such combination, which has been shown to be as effective as a standard multidrug regimen such as gentamicin and clindamycin in the management of intra-abdominal infections. The combination of ceftazidime, amikacin and metronidazole has been chosen as a comparator regimen because of its broad coverage of Gram-negative and anaerobic organisms found in such conditions.

Timeline

Start

2004-07

Primary completion

—

Completion

2005-04

Publications

• Chandra A, Dhar P, Dharap S, Goel A, Gupta R, Hardikar JV, Kapoor VK, Mathur AK, Modi P, Narwaria M, Ramesh MK, Ramesh H, Sastry RA, Shah S, Virk S, Sudheer OV, Sreevathsa MR, Varshney S, Kochhar P, Somasundaram S, Desai C, Schou M. Cefoperazone-sulbactam for treatment of intra-abdominal infections: results from a randomized, parallel group study in India. Surg Infect (Larchmt). 2008 Jun;9(3):367-76. doi: 10.1089/sur.2007.013.

Drugs

Indications