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Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA) | Clinical Trials | Clareo Health

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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

NCT00087490•Pfizer

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (126)

Pfizer Investigational Site

Montgomery, Alabama, United States

Pfizer Investigational Site

Tucson, Arizona, United States

Pfizer Investigational Site

Los Angeles, California, United States

Pfizer Investigational Site

Palm Springs, California, United States

Pfizer Investigational Site

Rancho Mirage, California, United States

Pfizer Investigational Site

San Pedro, California, United States

Pfizer Investigational Site

Santa Fe Springs, California, United States

Pfizer Investigational Site

Sylmar, California, United States

Pfizer Investigational Site

Torrance, California, United States

Pfizer Investigational Site

Torrance, California, United States

Key Dates

Start Date

October 1, 2004

Primary Completion Date

July 1, 2007

Completion Date

July 1, 2007

Last Updated

August 8, 2012

Enrollment

1,077

ACTUAL participants

Conditions

Skin/Soft Tissue InfectionsMethicillin Resistant Staphylococcus Aureus (MRSA)

Interventions

linezolid

DRUG

vancomycin

DRUG