Status:
COMPLETED
Complicated Skin and Skin Structure Infections
Lead Sponsor:
Pfizer
Conditions:
Skin Infection
Abscess
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.
Eligibility Criteria
Inclusion
- Subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections
- Within 72 hours before enrollment or at the time of enrollment, all subjects must provide an appropriate specimen for culture and susceptibility testing
- Subjects who have been given prior antibacterial therapy within 14 days of trial entry may be entered only if a culture is obtained showing persistence of a pathogen in blood or at the site of infection
Exclusion
- Subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or carbapenems
- Subjects with a history of seizure disorders or subjects currently receiving antiepileptic medication
- Subjects with underlying infections or conditions which would interfere with evaluation of this study
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2004
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00619710
Start Date
February 1 2001
End Date
April 1 2004
Last Update
September 1 2017
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