Complicated Skin and Skin Structure Infections
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Infection; Abscess; Cellulitis
Intervention: Meropenem (Drug); Imipenem-cilastatin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: AstraZeneca
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.
Clinical Details
Official title: 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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary measure is clinical response after all antibacterial treatment is stopped).
Secondary outcome: clinical and microbiological response
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: February 2001
Ending date: April 2004
Last updated: February 20, 2008
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