Clinical trial NCT00087490: Skin Structure Infections With Suspected or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)
Official title: Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin/Soft Tissue Infections
Methicillin Resistant Staphylococcus Aureus (MRSA)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2004-07-13
Enrollment: 1077
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population
timeFrame: EOS (6 to 28 days after the last dose of study drug)
Secondary outcomes:
measure: Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population
timeFrame: EOT (within 72 hours of last dose of study drug)
measure: Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population
timeFrame: EOS (6 to 28 days after the last dose of study drug)
measure: Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population
timeFrame: EOT (within 72 hours of last dose of study drug)
measure: Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population
timeFrame: EOS (6 to 28 days after the last dose of study drug)
measure: Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population
timeFrame: EOT (within 72 hours of last dose of study drug)
measure: Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population
timeFrame: EOS (6 to 28 days after the last dose of study drug)
measure: Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population
timeFrame: EOT (within 72 hours of last dose of study drug)
measure: Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population
timeFrame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)
measure: Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population
timeFrame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)
measure: Duration of Hospital Stay for PP Population
timeFrame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
measure: Duration of Hospital Stay for mITT Population
timeFrame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
measure: Duration of Intravenous Therapy for PP Population
timeFrame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
measure: Duration of Intravenous Therapy for mITT Population
timeFrame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
measure: Number of Participants Using Medical Resources
timeFrame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Palm Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: Pfizer Investigational Site
state: California
city: San Pedro
country: United States
facility: Pfizer Investigational Site
state: California
city: Santa Fe Springs
country: United States
facility: Pfizer Investigational Site
state: California
city: Sylmar
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Torrance
country: United States
facility: Pfizer Investigational Site
state: California
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Atlantis
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Blue Ridge
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Honolulu
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Decatur
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Hines
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Maywood
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: North Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Northlake
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Iowa City
country: United States
facility: Pfizer Investigational Site
state: Iowa
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Pfizer Investigational Site
state: Kentucky
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: West Roxbury
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: East Lansing
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Lansing
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Mpls
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St. Paul
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Butte
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Somers Point
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Stony Brook
country: United States
facility: Pfizer Investigational Site
state: New York
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Akron
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Akron
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Akron
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: West Reading
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Ducktown
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Jackson
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Forth Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: St. George
country: United States
facility: Pfizer Investigational Site
state: Utah
city: St. George
country: United States
facility: Pfizer Investigational Site
state: Utah
city: Tacoma
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Loma Hermosa
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Cordoba
country: Argentina
facility: Pfizer Investigational Site
city: Charleroi
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Montigny-le-Tilleul
country: Belgium
facility: Pfizer Investigational Site
city: São José do Rio Preto
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago
city: Santiago
country: Chile
facility: Pfizer Investigational Site
city: Barranquilla
country: Colombia
facility: Pfizer Investigational Site
state: Atlantico
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Floridablanca
country: Colombia
facility: Pfizer Investigational Site
state: Santander
city: Genova
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Udine
country: Italy
facility: Pfizer Investigational Site
city: Varese
country: Italy
facility: Pfizer Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
state: Jalisco
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Pragal
country: Portugal
facility: Pfizer Investigational Site
state: Almada
city: Amadora
country: Portugal
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Kuilsriver
country: South Africa
facility: Pfizer Investigational Site
state: Western Province
city: Johannesburg
country: South Africa
facility: Pfizer Investigational Site
city: Parow
country: South Africa
facility: Pfizer Investigational Site
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
city: Pretoria
country: South Africa
facility: Pfizer Investigational Site
city: Cordoba
country: Spain
facility: Pfizer Investigational Site
city: Gerona
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Winchester
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
city: Ciudad Bolívar
country: Venezuela
facility: Pfizer Investigational Site
state: Estado Bolívar
city: Distrito Capital
country: Venezuela
facility: Pfizer Investigational Site
state: Estado Miranda
city: Distrito Capital
country: Venezuela
facility: Pfizer Investigational Site
state: Estado Miranda
city: Maracaibo
country: Venezuela
facility: Pfizer Investigational Site
state: Estado Zulia
city: Valencia
country: Venezuela
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.