Complicated Skin and Skin Structure Infections

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca; Pfizer
• Treatments: Cilastatin; Cilastatin, Imipenem Drug Combination; Imipenem; Meropenem; Thienamycins

Criteria

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