Complicated Skin and Skin Structure Infections
Study identifier:3591IL/0079
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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.
Medical condition
Skin Infection, Abscess
Phase
Phase 3
Healthy volunteers
No
Study drug
Meropenem, Imipenem-cilastatin
Sex
All
Actual Enrollment
1000
Study type
Interventional
Age
13 Years +
Date
Study Start Date: 01 Feb 2001
Primary Completion Date: 01 Dec 2003
Study Completion Date: 01 Apr 2004
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Meropenem | Drug: Meropenem Intravenous Other Name: Merrem Drug: Meropenem Intravenous Other Name: Merrem Drug: Meropenem Intravenous Other Name: Merrem |
| Active Comparator: 2 Imipenem-cilastatin | Drug: Imipenem-cilastatin Intravenous Other Name: Primaxin |
