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

December 1, 2008 updated by: Pfizer

A Randomized, Open Label, Multicentre Phase Iv Study To Evaluate The Efficacy And Safety Of Magnex (Cefoperazone-Sulbactam) In Comparison With Ceftazidime Plus Amikacin And Metronidazole In The Treatment Of Intra-Abdominal Infections

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

307

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Bangalore, India, 560 054
        • Pfizer Investigational Site
      • Chandigarh, India, 160 012
        • Pfizer Investigational Site
      • Coimbatore, India, 641 014
        • Pfizer Investigational Site
      • Hyderabad, India, 500 068
        • Pfizer Investigational Site
      • Hyderabad, India
        • Pfizer Investigational Site
      • Lucknow, India, 226 003
        • Pfizer Investigational Site
      • Ludhiana, India, 141 001
        • Pfizer Investigational Site
      • Mumbai, India, 400 012
        • Pfizer Investigational Site
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 009
        • Pfizer Investigational Site
      • Ahmedabad, Gujarat, India, 380 052
        • Pfizer Investigational Site
      • Ahmedabad, Gujarat, India, 380016
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560 001
        • Pfizer Investigational Site
    • Kerala
      • Kochi, Kerala, India, 682 026
        • Pfizer Investigational Site
      • Kochi, Kerala, India, 682304
        • Pfizer Investigational Site
    • Madhya Pradesh
      • Bhopal, Madhya Pradesh, India, 462 038
        • Pfizer Investigational Site
      • Indore, Madhya Pradesh, India, 452 014
        • Pfizer Investigational Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 022
        • Pfizer Investigational Site
      • Pune, Maharashtra, India, 411 001
        • Pfizer Investigational Site
    • Rajasthan
      • Jaipur, Rajasthan, India, 302015
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226 014
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of clinical efficacy-evaluable subjects who present with continued resolution at the 30-day follow-up visit.
Adverse events as observed by the investigator or volunteered as responses to unsolicited and non-leading questions.
Vital signs including systolic and diastolic blood pressures, pulse rate and respiratory rate.
Physical examination findings.

Secondary Outcome Measures

Outcome Measure
The proportion of clinical efficacy
evaluable subjects who are classified as having a clinical outcome of success or improvement at the end of study treatment;
proportion of microbiological efficacy-evaluable subjects who have a successful microbiological outcome
success or presumed success) at the end of study treatment,
Total duration of study treatment
Comparison of pharmaco-economic data (cost effectiveness) for cefoperazone- sulbactam versus the combination of ceftazidime - amikacin - metronidazole.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

August 3, 2006

First Submitted That Met QC Criteria

August 3, 2006

First Posted (Estimate)

August 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 2, 2008

Last Update Submitted That Met QC Criteria

December 1, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A1891002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe