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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00619710 |
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.
Condition | Intervention | Phase |
---|---|---|
Skin Infection Abscess Cellulitis |
Drug: Meropenem Drug: Imipenem-cilastatin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 1000 |
Study Start Date: | February 2001 |
Study Completion Date: | April 2004 |
Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Meropenem
|
Drug: Meropenem
Intravenous
|
2: Active Comparator
Imipenem-cilastatin
|
Drug: Imipenem-cilastatin
Intravenous
|
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 3591IL/0079, D9211C00079 |
Study First Received: | February 6, 2008 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00619710 |
Health Authority: | United States: Food and Drug Administration |
skin infections MERREM PRIMAXIN IV complex abscess perirectal abscess |
wound infections infected ischemic/diabetic ulcers cellulitis Meropenem Imipenem-cilastatin |
Skin Diseases Ulcer Ischemia Inflammation Imipenem Cellulitis Skin Diseases, Infectious |
Abscess Meropenem Cilastatin Connective Tissue Diseases Suppuration Wound Infection |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases Pathologic Processes Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Infection Pharmacologic Actions Protease Inhibitors |