Complicated Skin and Skin Structure Infections

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00619710

Collaborator

(none)

1,000

Enrollment

Arms

37.9

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Skin Infection Abscess Cellulitis	Drug: Meropenem Drug: Imipenem-cilastatin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2001

Actual Primary Completion Date :

Dec 1, 2003

Actual Study Completion Date :

Apr 1, 2004

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 1

Meropenem

Drug: Meropenem

Intravenous

Other Names:

Merrem

Active Comparator: 2

Imipenem-cilastatin

Drug: Imipenem-cilastatin

Intravenous

Other Names:

Primaxin

Outcome Measures

Primary Outcome Measures

The primary measure is clinical response after all antibacterial treatment is stopped). [7-28 days]

Secondary Outcome Measures

clinical and microbiological response [Twice 3-28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts 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