Status:
COMPLETED
A Comparative Phase IV Study Evaluating Efficacy & Safety Of Magnex(Cefoperazone-Sulbactam) In Intraabdominal Infections
Lead Sponsor:
Pfizer
Conditions:
Infection
Eligibility:
All Genders
12+ years
Phase:
PHASE4
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 Enterobacter...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
307 Patients enrolled
Trial Details
Trial ID
NCT00360607
Start Date
July 1 2004
End Date
April 1 2005
Last Update
December 2 2008
Active Locations (20)
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1
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 009
2
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 052
3
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380016
4
Pfizer Investigational Site
Bangalore, Karnataka, India, 560 001