Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00087490

Purpose

To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects

Condition	Intervention	Phase
Skin/Soft Tissue Infections Methicillin Resistant Staphylococcus Aureus (MRSA)	Drug: linezolid Drug: vancomycin	Phase IV

Drug Information available for: Vancomycin Linezolid Vancomycin hydrochloride Methicillin Methicillin sodium

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	1077
Study Start Date:	October 2004
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Eligibility

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087490

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5951002
Study First Received:	July 9, 2004
Last Updated:	July 9, 2008
ClinicalTrials.gov Identifier:	NCT00087490
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Methicillin

Soft Tissue Infections
Vancomycin
Linezolid

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009