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

Methicillin Resistant Staphylococcus Aureus (MRSA) Clinical Trial

Official title:

Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087490
• Other study ID #: A5951002
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2004
• Last updated: June 29, 2012
• Start date: October 2004
• Est. completion date: July 2007

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1077
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• linezolid

• vancomycin

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Cordoba
Argentina	Pfizer Investigational Site	Loma Hermosa	Buenos Aires
Belgium	Pfizer Investigational Site	Charleroi
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Montigny-le-Tilleul
Brazil	Pfizer Investigational Site	São José do Rio Preto	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Chile	Pfizer Investigational Site	Providencia	Santiago
Chile	Pfizer Investigational Site	Santiago
Colombia	Pfizer Investigational Site	Barranquilla	Atlantico
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Floridablanca	Santander
Italy	Pfizer Investigational Site	Genova
Italy	Pfizer Investigational Site	Napoli
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Roma
Italy	Pfizer Investigational Site	Udine
Italy	Pfizer Investigational Site	Varese
Malaysia	Pfizer Investigational Site	Kuala Lumpur
Malaysia	Pfizer Investigational Site	Kuala Lumpur
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	Monterrey	Nuevo Leon
Portugal	Pfizer Investigational Site	Amadora
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Lisboa
Portugal	Pfizer Investigational Site	Pragal	Almada
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Smolensk
Singapore	Pfizer Investigational Site	Singapore
South Africa	Pfizer Investigational Site	Johannesburg
South Africa	Pfizer Investigational Site	Kuilsriver	Western Province
South Africa	Pfizer Investigational Site	Parow
South Africa	Pfizer Investigational Site	Pretoria
South Africa	Pfizer Investigational Site	Pretoria
Spain	Pfizer Investigational Site	Cordoba
Spain	Pfizer Investigational Site	Gerona
Spain	Pfizer Investigational Site	Sevilla
United Kingdom	Pfizer Investigational Site	Edinburgh
United Kingdom	Pfizer Investigational Site	Leeds
United Kingdom	Pfizer Investigational Site	Winchester	Hampshire
United States	Pfizer Investigational Site	Akron	Ohio
United States	Pfizer Investigational Site	Akron	Ohio
United States	Pfizer Investigational Site	Akron	Ohio
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlantis	Florida
United States	Pfizer Investigational Site	Augusta	Georgia
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Blue Ridge	Georgia
United States	Pfizer Investigational Site	Boston	Massachusetts
United States	Pfizer Investigational Site	Butte	Montana
United States	Pfizer Investigational Site	Chicago	Illinois
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Columbus	Ohio
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Dallas	Texas
United States	Pfizer Investigational Site	Decatur	Illinois
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Denver	Colorado
United States	Pfizer Investigational Site	Ducktown	Tennessee
United States	Pfizer Investigational Site	East Lansing	Michigan
United States	Pfizer Investigational Site	Fort Worth	Texas
United States	Pfizer Investigational Site	Forth Worth	Texas
United States	Pfizer Investigational Site	Hartford	Connecticut
United States	Pfizer Investigational Site	Hartford	Connecticut
United States	Pfizer Investigational Site	Hines	Illinois
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Honolulu	Hawaii
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Iowa City	Iowa
United States	Pfizer Investigational Site	Jackson	Tennessee
United States	Pfizer Investigational Site	Lansing	Michigan
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Lincoln	Nebraska
United States	Pfizer Investigational Site	Los Angeles	California
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Maywood	Illinois
United States	Pfizer Investigational Site	Melbourne	Florida
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Montgomery	Alabama
United States	Pfizer Investigational Site	Mpls	Minnesota
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	North Chicago	Illinois
United States	Pfizer Investigational Site	Northlake	Illinois
United States	Pfizer Investigational Site	Palm Springs	California
United States	Pfizer Investigational Site	Pensacola	Florida
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
United States	Pfizer Investigational Site	Philadelphia	Pennsylvania
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	Somers Point	New Jersey
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	Springfield	Illinois
United States	Pfizer Investigational Site	St. George	Utah
United States	Pfizer Investigational Site	St. George	Utah
United States	Pfizer Investigational Site	St. Paul	Minnesota
United States	Pfizer Investigational Site	Stony Brook	New York
United States	Pfizer Investigational Site	Sylmar	California
United States	Pfizer Investigational Site	Tacoma	Washington
United States	Pfizer Investigational Site	Toledo	Ohio
United States	Pfizer Investigational Site	Torrance	California
United States	Pfizer Investigational Site	Torrance	California
United States	Pfizer Investigational Site	Torrance	California
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	West Reading	Pennsylvania
United States	Pfizer Investigational Site	West Roxbury	Massachusetts
United States	Pfizer Investigational Site	Winston-Salem	North Carolina
Venezuela	Pfizer Investigational Site	Ciudad Bolívar	Estado Bolívar
Venezuela	Pfizer Investigational Site	Distrito Capital	Estado Miranda
Venezuela	Pfizer Investigational Site	Distrito Capital	Estado Miranda
Venezuela	Pfizer Investigational Site	Maracaibo	Estado Zulia
Venezuela	Pfizer Investigational Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Venezuela,  Argentina,  Belgium,  Brazil,  Chile,  Colombia,  Italy,  Malaysia,  Mexico,  Portugal,  Russian Federation,  Singapore,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population	Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs or (/) symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis.	EOS (6 to 28 days after the last dose of study drug)	No
Secondary	Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population	CR evaluated at EOT visit as "success" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown": excluded from present analysis.	EOT (within 72 hours of last dose of study drug)	No
Secondary	Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population	CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOS, CR was evaluated as "success" (cure: resolution of clinical signs/symptoms of infection when compared to baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown" was excluded from present analysis.	EOS (6 to 28 days after the last dose of study drug)	No
Secondary	Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population	CR evaluated at EOT visit as "success" (cure: resolution of clinical sign/symptoms of infection when compared with baseline; and improvement: 2/more improvement in clinical sign/symptoms of infection when compared with baseline); "failure": persistence/progression of baseline signs/symptoms of infection after at least 2 days of treatment/development of new clinical findings consistent with active infection; "unknown": extenuating circumstances precluding classification to 1 of above. "Unknown": excluded from present analysis.	EOT (within 72 hours of last dose of study drug)	No
Secondary	Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population	Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).	EOS (6 to 28 days after the last dose of study drug)	No
Secondary	Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population	Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).	EOT (within 72 hours of last dose of study drug)	No
Secondary	Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population	Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture; recurrence: presence of isolate at EOS, that was eradicated at EOT).	EOS (6 to 28 days after the last dose of study drug)	No
Secondary	Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population	Microbiological outcome dichotomized to "success" (eradication: absence of baseline isolate (BI) in culture of original infection site (IS); presumed eradication: participant cured and no specimen available for culture; superinfection: clinically failed or improved with new pathogen identified from primary IS other than BI; colonization: isolate was present but not producing infection) and "failure" (persistence: BI present in original IS; presumed persistence: clinically failed and no specimen available for culture).	EOT (within 72 hours of last dose of study drug)	No
Secondary	Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population	Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded by the sponsor using wound parameter score ranging from 0 to 3; "0= none, 1= mild, 2= moderate and 3= severe".	EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)	No
Secondary	Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population	Participant's clinical evaluation of signs and symptoms were based on global assessment by investigator at specific timepoints. Signs and symptoms of an active skin or soft tissue infection caused by suspected MRSA included purulent discharge, nonpurulent discharge, erythema, swelling, induration, tenderness, pain and local skin warmth. It was recorded using wound parameter score ranging from 0 to 3; "0= none, 1= mild, 2= moderate and 3= severe".	EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)	No
Secondary	Duration of Hospital Stay for PP Population	Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.	Baseline up to EOS (6 to 28 days after the last dose of study drug)	No
Secondary	Duration of Hospital Stay for mITT Population	Duration of Hospital Stay was defined as the number of days the participant was cared as an inpatient in the hospital during the maximum 34 days of the study period. The number of days in the hospital was counted from start of study medication to date of discharge or last date known to be in the hospital (for missing discharge dates and participants who died) or Day 34 for participants who continued hospitalization beyond EOS period.	Baseline up to EOS (6 to 28 days after the last dose of study drug)	No
Secondary	Duration of Intravenous Therapy for PP Population	Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.	Baseline up to EOS (6 to 28 days after the last dose of study drug)	No
Secondary	Duration of Intravenous Therapy for mITT Population	Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.	Baseline up to EOS (6 to 28 days after the last dose of study drug)	No
Secondary	Number of Participants Using Medical Resources	Medical resources utilization included a daily log of the participants' location in the hospital and outside of the hospital (non-hospital location), adjusted duration of stay (difference between duration of stay and the duration of discharge delay) and daily log of study drug dosing.	Baseline up to EOS (6 to 28 days after the last dose of study drug)	No

External Links

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