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

NCT00360607 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2008-12-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Magnex (Sulbactam Sodium/Cefoperazone Sodium 1:1) Pfizer Ltd.

DRUG

Fortum (Ceftazidime for injection USP) Glaxo Smith Kline Pharmaceuticals Limited

DRUG

Metrogyl (Metronidazole Injection IP) J.B.Chemicals & Pharmaceuticals Ltd.

DRUG

Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Completion
2005-04-30

Countries

  • India

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00360607 on ClinicalTrials.gov