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

NCT ID: NCT00360607

Last Updated: 2008-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type DRUG

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

Intervention Type DRUG

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

Intervention Type DRUG

Mikacin (Amikacin Sulphate Injection IP) Aristo Pharmaceuticals Ltd.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Ahmedabad, Gujarat, India

Site Status

Pfizer Investigational Site

Ahmedabad, Gujarat, India

Site Status

Pfizer Investigational Site

Ahmedabad, Gujarat, India

Site Status

Pfizer Investigational Site

Bangalore, Karnataka, India

Site Status

Pfizer Investigational Site

Kochi, Kerala, India

Site Status

Pfizer Investigational Site

Kochi, Kerala, India

Site Status

Pfizer Investigational Site

Bhopal, Madhya Pradesh, India

Site Status

Pfizer Investigational Site

Indore, Madhya Pradesh, India

Site Status

Pfizer Investigational Site

Mumbai, Maharashtra, India

Site Status

Pfizer Investigational Site

Pune, Maharashtra, India

Site Status

Pfizer Investigational Site

Jaipur, Rajasthan, India

Site Status

Pfizer Investigational Site

Lucknow, Uttar Pradesh, India

Site Status

Pfizer Investigational Site

Bangalore, , India

Site Status

Pfizer Investigational Site

Chandigarh, , India

Site Status

Pfizer Investigational Site

Coimbatore, , India

Site Status

Pfizer Investigational Site

Hyderabad, , India

Site Status

Pfizer Investigational Site

Hyderabad, , India

Site Status

Pfizer Investigational Site

Lucknow, , India

Site Status

Pfizer Investigational Site

Ludhiana, , India

Site Status

Pfizer Investigational Site

Mumbai, , India

Site Status

Countries

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India

References

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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.

Reference Type DERIVED
PMID: 18570578 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1891002&StudyName=A+Comparative+Phase+IV+Study+Evaluating+Efficacy+%26+Safety+Of+Magnex%28Cefoperazone%2DSulbactam%29+In+Intraabdominal+Infections

To obtain contact information for a study center near you, click here.

Other Identifiers

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A1891002

Identifier Type: -

Identifier Source: org_study_id