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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