Status:
COMPLETED
Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Lead Sponsor:
Pfizer
Conditions:
Skin/Soft Tissue Infections
Methicillin Resistant Staphylococcus Aureus (MRSA)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
1077 Patients enrolled
Trial Details
Trial ID
NCT00087490
Start Date
October 1 2004
End Date
July 1 2007
Last Update
August 8 2012
Active Locations (126)
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1
Pfizer Investigational Site
Montgomery, Alabama, United States, 36106
2
Pfizer Investigational Site
Tucson, Arizona, United States, 85723
3
Pfizer Investigational Site
Los Angeles, California, United States, 90033
4
Pfizer Investigational Site
Palm Springs, California, United States, 92262