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

2014-07-23 21:35:36 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Infection

Intervention

Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd., Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited, Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd., Mikacin (Amikacin Sulphate Injecti

Location

Pfizer Investigational Site
Ahmedabad
Gujarat
India
380016

Status

Completed

Source

Pfizer

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:35:36-0400

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