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Complicated Skin and Skin Structure Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00619710
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : September 1, 2017
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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.

Condition or disease Intervention/treatment Phase
Skin Infection Abscess Cellulitis Drug: Meropenem Drug: Imipenem-cilastatin Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2001
Actual Primary Completion Date : December 2003
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: Meropenem
Other Name: Merrem

Active Comparator: 2
Drug: Imipenem-cilastatin
Other Name: Primaxin

Primary Outcome Measures :
  1. The primary measure is clinical response after all antibacterial treatment is stopped). [ Time Frame: 7-28 days ]

Secondary Outcome Measures :
  1. clinical and microbiological response [ Time Frame: Twice 3-28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Layout table for additonal information Identifier: NCT00619710    
Other Study ID Numbers: 3591IL/0079
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Keywords provided by Pfizer:
skin infections
complex abscess
perirectal abscess
wound infections
infected ischemic/diabetic ulcers
Additional relevant MeSH terms:
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Communicable Diseases
Skin Diseases, Infectious
Pathologic Processes
Connective Tissue Diseases
Skin Diseases
Cilastatin, Imipenem Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action