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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Infection

Treatments

Drug: Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.

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

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

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00360607

A1891002

Details and patient eligibility

About

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.

Enrollment

307 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female subjects aged greater or equal to 12 years
Intra-abdominal infection documented by laparotomy or laparoscopy or percutaneous aspiration within 24 hours prior to screening
Presence of at least three of the following five indicators consistent with intra-abdominal infections (Fever, leucocytosis, abdominal symptoms, abdominal signs, radiological evaluation)
Written informed consent obtained

Exclusion criteria

Rapidly progressive illness or critically ill subjects
Pregnant or lactating women, or women of childbearing potential not using an effective method of contraception.
Treatment with a presumably effective systemic antimicrobial agent for >24 hours within a 72 hour period prior to study entry unless the subject did not sufficiently respond to the treatment (as judged by the investigator)