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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00087490
First received: July 9, 2004
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  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 4

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:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population [ Time Frame: EOS (6 to 28 days after the last dose of study drug) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population [ Time Frame: EOT (within 72 hours of last dose of study drug) ] [ Designated as safety issue: No ]
    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.

  • Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population [ Time Frame: EOS (6 to 28 days after the last dose of study drug) ] [ Designated as safety issue: No ]
    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.

  • Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population [ Time Frame: EOT (within 72 hours of last dose of study drug) ] [ Designated as safety issue: No ]
    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.

  • Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population [ Time Frame: EOS (6 to 28 days after the last dose of study drug) ] [ Designated as safety issue: No ]
    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).

  • Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population [ Time Frame: EOT (within 72 hours of last dose of study drug) ] [ Designated as safety issue: No ]
    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).

  • Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population [ Time Frame: EOS (6 to 28 days after the last dose of study drug) ] [ Designated as safety issue: No ]
    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).

  • Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population [ Time Frame: EOT (within 72 hours of last dose of study drug) ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population [ Time Frame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug) ] [ Designated as safety issue: No ]
    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".

  • Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population [ Time Frame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug) ] [ Designated as safety issue: No ]
    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".

  • Duration of Hospital Stay for PP Population [ Time Frame: Baseline up to EOS (6 to 28 days after the last dose of study drug) ] [ Designated as safety issue: No ]
    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.

  • Duration of Hospital Stay for mITT Population [ Time Frame: Baseline up to EOS (6 to 28 days after the last dose of study drug) ] [ Designated as safety issue: No ]
    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.

  • Duration of Intravenous Therapy for PP Population [ Time Frame: Baseline up to EOS (6 to 28 days after the last dose of study drug) ] [ Designated as safety issue: No ]
    Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.

  • Duration of Intravenous Therapy for mITT Population [ Time Frame: Baseline up to EOS (6 to 28 days after the last dose of study drug) ] [ Designated as safety issue: No ]
    Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.

  • Number of Participants Using Medical Resources [ Time Frame: Baseline up to EOS (6 to 28 days after the last dose of study drug) ] [ Designated as safety issue: No ]
    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.


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 by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00087490     History of Changes
Other Study ID Numbers: A5951002
Study First Received: July 9, 2004
Results First Received: June 29, 2012
Last Updated: June 29, 2012
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 May 23, 2013