Complicated Skin and Skin Structure Infections

Pfizer

Status and phase

Completed

Phase 3

Conditions

Cellulitis

Skin Infection

Abscess

Treatments

Drug: Imipenem-cilastatin

Drug: Meropenem

Study type

Interventional

Funder types

Industry

Identifiers

NCT00619710

3591IL/0079

D9211C00079

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

13+ years old

Volunteers

No 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