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Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
This study has been completed.
Study NCT00087490   Information provided by Pfizer
First Received: July 9, 2004   Last Updated: July 9, 2008   History of Changes

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
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
 
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

 
Phase IV
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
  • Skin/Soft Tissue Infections
  • Methicillin Resistant Staphylococcus Aureus (MRSA)
  • Drug: linezolid
  • Drug: vancomycin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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
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
 
 
NCT00087490
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
A5951002
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP