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

NCT ID: NCT00087490

Last Updated: 2012-08-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1077 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-07-31

Brief Summary

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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

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Conditions

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Skin/Soft Tissue Infections Methicillin Resistant Staphylococcus Aureus (MRSA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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linezolid

Intervention Type DRUG

vancomycin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Montgomery, Alabama, United States

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Tucson, Arizona, United States

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Los Angeles, California, United States

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Palm Springs, California, United States

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Rancho Mirage, California, United States

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San Pedro, California, United States

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Santa Fe Springs, California, United States

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Sylmar, California, United States

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Torrance, California, United States

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Torrance, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Hartford, Connecticut, United States

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Hartford, Connecticut, United States

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New Haven, Connecticut, United States

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New Haven, Connecticut, United States

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Atlantis, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Pensacola, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Blue Ridge, Georgia, United States

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Honolulu, Hawaii, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Decatur, Illinois, United States

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Hines, Illinois, United States

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Maywood, Illinois, United States

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North Chicago, Illinois, United States

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Northlake, Illinois, United States

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Springfield, Illinois, United States

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Springfield, Illinois, United States

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Iowa City, Iowa, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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West Roxbury, Massachusetts, United States

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East Lansing, Michigan, United States

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Lansing, Michigan, United States

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Minneapolis, Minnesota, United States

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Mpls, Minnesota, United States

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Saint Paul, Minnesota, United States

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Butte, Montana, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Somers Point, New Jersey, United States

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Stony Brook, New York, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Akron, Ohio, United States

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Akron, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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West Reading, Pennsylvania, United States

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Ducktown, Tennessee, United States

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Jackson, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Forth Worth, Texas, United States

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Houston, Texas, United States

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St. George, Utah, United States

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St. George, Utah, United States

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Tacoma, Washington, United States

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Buenos Aires, Buenos Aires, Argentina

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Loma Hermosa, Buenos Aires, Argentina

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Buenos Aires, , Argentina

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Córdoba, , Argentina

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Charleroi, , Belgium

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Ghent, , Belgium

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Montigny-le-Tilleul, , Belgium

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São José do Rio Preto, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Providencia, Santiago Metropolitan, Chile

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Santiago, , Chile

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Barranquilla, Atlántico, Colombia

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Bogota, Cundinamarca, Colombia

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Floridablanca, Santander Department, Colombia

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Genova, , Italy

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Napoli, , Italy

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Roma, , Italy

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Roma, , Italy

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Udine, , Italy

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Varese, , Italy

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Kuala Lumpur, , Malaysia

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Kuala Lumpur, , Malaysia

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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Monterrey, Nuevo León, Mexico

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Pragal, Almada, Portugal

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Amadora, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Moscow, , Russia

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Moscow, , Russia

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Smolensk, , Russia

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Singapore, Singapore, Singapore

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Kuilsriver, Western Province, South Africa

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Johannesburg, , South Africa

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Parow, , South Africa

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Pretoria, , South Africa

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Pretoria, , South Africa

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Córdoba, Cordoba, Spain

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Girona, Gerona, Spain

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Seville, Sevilla, Spain

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Winchester, Hampshire, United Kingdom

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Edinburgh, , United Kingdom

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Leeds, , United Kingdom

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Ciudad Bolívar, Bolívar, Venezuela

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Distrito Capital, Miranda, Venezuela

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Distrito Capital, Miranda, Venezuela

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Valencia, Valencia, Venezuela

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Maracaibo, Zulia, Venezuela

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Countries

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Germany Ireland United States Argentina Belgium Brazil Chile Colombia Italy Malaysia Mexico Portugal Russia Singapore South Africa Spain United Kingdom Venezuela

References

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Puzniak LA, Morrow LE, Huang DB, Barreto JN. Impact of weight on treatment efficacy and safety in complicated skin and skin structure infections and nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus. Clin Ther. 2013 Oct;35(10):1557-70. doi: 10.1016/j.clinthera.2013.08.001. Epub 2013 Sep 3.

Reference Type DERIVED
PMID: 24011955 (View on PubMed)

Itani KM, Biswas P, Reisman A, Bhattacharyya H, Baruch AM. Clinical efficacy of oral linezolid compared with intravenous vancomycin for the treatment of methicillin-resistant Staphylococcus aureus-complicated skin and soft tissue infections: a retrospective, propensity score-matched, case-control analysis. Clin Ther. 2012 Aug;34(8):1667-73.e1. doi: 10.1016/j.clinthera.2012.06.018. Epub 2012 Jul 6.

Reference Type DERIVED
PMID: 22770644 (View on PubMed)

Related Links

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Other Identifiers

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A5951002

Identifier Type: -

Identifier Source: org_study_id