Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

Pfizer

Status and phase

Completed

Phase 4

Conditions

Skin/Soft Tissue Infections

Methicillin Resistant Staphylococcus Aureus (MRSA)

Treatments

Drug: linezolid

Drug: vancomycin

Study type

Interventional

Funder types

Industry

Identifiers

A5951002

Details and patient eligibility

About

To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects

Enrollment

1,077 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results).
Signs and symptoms consistent with infection
Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus

Exclusion criteria

Subjects who were treated with a previous antibiotic (systemic or topical) with MRSA activity (other than linezolid or vancomycin) for more than 24 hours and treatment extended into the 72 hour period prior to the first dose of study drug, unless documented to be a treatment failure (72 hours of treatment and not responding).
Subjects with uncomplicated skin or superficial skin structure infection such as superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that only need surgical drainage for cure.
Subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis