Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (M… (NCT00087490) | Clinical Trial Compass
CompletedPhase 4
Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
United States1,077 participantsStarted 2004-10
Plain-language summary
To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population
Timeframe: EOS (6 to 28 days after the last dose of study drug)