Complicated Skin and Skin Structure Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2004-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Skin Infection Abscess Cellulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Meropenem

Group Type EXPERIMENTAL

Meropenem

Intervention Type DRUG

Intravenous

2

Imipenem-cilastatin

Group Type ACTIVE_COMPARATOR

Imipenem-cilastatin

Intervention Type DRUG

Intravenous

Interventions

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Meropenem

Intravenous

Intervention Type DRUG

Imipenem-cilastatin

Intravenous

Intervention Type DRUG

Other Intervention Names

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Merrem Primaxin

Eligibility Criteria

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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

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No