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

Phase 4

Completed

• Conditions: Infection

• Registration Number: NCT00360607
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-07
• Study Completion: 2005-04
• Study First Submitted: 2006-08-03
• Study First Submitted QC: 2006-08-03
• Study First Posted: 2006-08-04
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-01
• Last Update Posted: 2008-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 307

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇮🇳 Mumbai, India