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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus

Resource links provided by NLM:

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

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Show 126 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

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

Additional relevant MeSH terms:

Staphylococcal Infections
Soft Tissue Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Infection
Methicillin
Vancomycin
Linezolid

Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012