Complicated Skin and Skin Structure Infections
Phase 3
Completed
- Conditions
- CellulitisSkin InfectionAbscess
- Interventions
- Registration Number
- NCT00619710
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Meropenem Meropenem 2 Imipenem-cilastatin Imipenem-cilastatin
- Primary Outcome Measures
Name Time Method The primary measure is clinical response after all antibacterial treatment is stopped). 7-28 days
- Secondary Outcome Measures
Name Time Method clinical and microbiological response Twice 3-28 days