Skin Infection, Abscess, Cellulitis
Conditions
Keywords
skin infections, MERREM, PRIMAXIN IV, complex abscess, perirectal abscess, wound infections, infected ischemic/diabetic ulcers, cellulitis, Meropenem, Imipenem-cilastatin
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.
Interventions
DRUGMeropenem
Intravenous
Intravenous
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary measure is clinical response after all antibacterial treatment is stopped). | 7-28 days |
Secondary
| Measure | Time frame |
|---|---|
| clinical and microbiological response | Twice 3-28 days |
Outcome results
None listed