Complicated Skin and Skin Structure Infections

August 31, 2017 updated by: Pfizer

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Meropenem
Drug: Meropenem
Intravenous
Other Names:
  • Merrem
Active Comparator: 2
Imipenem-cilastatin
Drug: Imipenem-cilastatin
Intravenous
Other Names:
  • Primaxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary measure is clinical response after all antibacterial treatment is stopped).
Time Frame: 7-28 days
7-28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical and microbiological response
Time Frame: Twice 3-28 days
Twice 3-28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

December 1, 2003

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

February 6, 2008

First Submitted That Met QC Criteria

February 20, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3591IL/0079
  • D9211C00079

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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