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OpenTrials
Completed

NCT Number: NCT00619710

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.

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Key information

Conditions

Skin Infection Abscess Cellulitis Connective Tissue Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Wound Infection

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meropenem

Drug

Intravenous

Other names: Merrem

Imipenem-cilastatin

Drug

Intravenous

Other names: Primaxin

Primary outcomes

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

    Time frame: 7-28 days

Secondary outcomes

  1. clinical and microbiological response

    Time frame: Twice 3-28 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2001
Primary completion
2003
Study completion
2004
First posted
Feb 21, 2008
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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