Overview

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