July 9, 2004 |
July 9, 2008 |
October 2004 |
To compare the clinical efficacy of linezolid to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects at the End of Study (EOS) visit |
Same as current |
Complete list of historical versions of study NCT00087490 on ClinicalTrials.gov Archive Site |
- To compare the clinical efficacy, and safety and tolerability of linezolid to vancomycin in the treatment of cSSTI due to MRSA in adult subjects at the End of Treatment (EOT) visit.
- To compare the bacteriological efficacy, and safety and tolerability
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To compare the clinical efficacy, and safety and tolerability of linezolid to vancomycin in the treatment of cSSTI due to MRSA in adult subjects at the End of Treatment (EOT) visit.
To compare the bacteriological efficacy, and safety and tolerability |
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Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) |
Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus |
To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects |
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Phase IV |
Interventional |
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
- Skin/Soft Tissue Infections
- Methicillin Resistant Staphylococcus Aureus (MRSA)
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- Drug: linezolid
- Drug: vancomycin
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Completed |
1077 |
July 2007 |
July 2007 (final data collection date for primary outcome measure) |
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
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Both |
18 Years and older |
No |
Contact information is only displayed when the study is recruiting subjects |
United States, Argentina, Belgium, Brazil, Chile, Colombia, Italy, Malaysia, Mexico, Portugal, Russian Federation, Singapore, South Africa, Spain, United Kingdom, Venezuela |
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NCT00087490 |
Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
A5951002 |
Pfizer |
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Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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Pfizer |
July 2008 |