Complicated Skin and Skin Structure Infections
Overview
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.
Full Title of Study: “A Multicenter, Randomized, Double Blind, Comparative Trial of Intravenous MERREM (Meropenem, ICI 194,660) vs PRIMAXIN I.V. (Imipenem-cilastatin) in the Treatment of Hospitalised Subjects With Complicated Skin and Skin Structure Infections.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: December 2003
Interventions
- Drug: Meropenem
- Intravenous
- Drug: Imipenem-cilastatin
- Intravenous
Arms, Groups and Cohorts
- Experimental: 1
- Meropenem
- Active Comparator: 2
- Imipenem-cilastatin
Clinical Trial Outcome Measures
Primary Measures
- The primary measure is clinical response after all antibacterial treatment is stopped).
- Time Frame: 7-28 days
Secondary Measures
- clinical and microbiological response
- Time Frame: Twice 3-28 days
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 13 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Pfizer
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