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Complicated Skin and Skin Structure Infections

Primary Purpose

Skin Infection, Abscess, Cellulitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Meropenem
Imipenem-cilastatin
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Infection focused on measuring skin infections, MERREM, PRIMAXIN IV, complex abscess, perirectal abscess, wound infections, infected ischemic/diabetic ulcers, cellulitis, Meropenem, Imipenem-cilastatin

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Meropenem

    Imipenem-cilastatin

    Outcomes

    Primary Outcome Measures

    The primary measure is clinical response after all antibacterial treatment is stopped).

    Secondary Outcome Measures

    clinical and microbiological response

    Full Information

    First Posted
    February 6, 2008
    Last Updated
    August 31, 2017
    Sponsor
    Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00619710
    Brief Title
    Complicated Skin and Skin Structure Infections
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2001 (undefined)
    Primary Completion Date
    December 2003 (Actual)
    Study Completion Date
    April 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin Infection, Abscess, Cellulitis
    Keywords
    skin infections, MERREM, PRIMAXIN IV, complex abscess, perirectal abscess, wound infections, infected ischemic/diabetic ulcers, cellulitis, Meropenem, Imipenem-cilastatin

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Meropenem
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    Imipenem-cilastatin
    Intervention Type
    Drug
    Intervention Name(s)
    Meropenem
    Other Intervention Name(s)
    Merrem
    Intervention Description
    Intravenous
    Intervention Type
    Drug
    Intervention Name(s)
    Imipenem-cilastatin
    Other Intervention Name(s)
    Primaxin
    Intervention Description
    Intravenous
    Primary Outcome Measure Information:
    Title
    The primary measure is clinical response after all antibacterial treatment is stopped).
    Time Frame
    7-28 days
    Secondary Outcome Measure Information:
    Title
    clinical and microbiological response
    Time Frame
    Twice 3-28 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Complicated Skin and Skin Structure Infections

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