Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
NCT00087490
ABOUT THIS STUDY
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- 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
- 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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Descriptive Information | ||||
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Brief Title ICMJE | Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) | |||
Official Title ICMJE | Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus | |||
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 | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 1077 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | July 2007 | |||
Actual Primary Completion Date | July 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Belgium, Brazil, Chile, Colombia, Italy, Malaysia, Mexico, Portugal, Russian Federation, Singapore, South Africa, Spain, United Kingdom, United States, Venezuela | |||
Removed Location Countries | Germany, Ireland | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00087490 | |||
Other Study ID Numbers ICMJE | A5951002 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |