Back to results

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

Primary Purpose

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

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

linezolid

vancomycin

About this trial

This is an interventional treatment trial for Skin/Soft Tissue Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population

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).

Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population

Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population

Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population

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".

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".

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.

Duration of Hospital Stay for mITT Population

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.

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.

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.

Full Information

NCT ID

NCT00087490

First Posted

July 9, 2004

Last Updated

June 29, 2012

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00087490

Brief Title

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

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

October 2004 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1077 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

linezolid

Intervention Type

Drug

Intervention Name(s)

vancomycin

Primary Outcome Measure Information:

Title

Clinical Outcome in Participants With Baseline Methicillin-Resistant Staphylococcus Aureus (MRSA) at End of Study (EOS) for Per-Protocol (PP) Population

Description

Time Frame

EOS (6 to 28 days after the last dose of study drug)

Secondary Outcome Measure Information:

Title

Clinical Outcome in Participants With Baseline MRSA at End of Treatment (EOT) for PP Population

Description

Time Frame

EOT (within 72 hours of last dose of study drug)

Title

Clinical Outcome in Participants With Baseline MRSA at EOS for Modified-Intent to Treat (mITT) Population

Description

Time Frame

EOS (6 to 28 days after the last dose of study drug)

Title

Clinical Outcome in Participants With Baseline MRSA at EOT for mITT Population

Description

Time Frame

EOT (within 72 hours of last dose of study drug)

Title

Microbiological Outcome in Participants With Baseline MRSA at EOS for PP Population

Description

Time Frame

EOS (6 to 28 days after the last dose of study drug)

Title

Microbiological Outcome in Participants With Baseline MRSA at EOT for PP Population

Description

Time Frame

EOT (within 72 hours of last dose of study drug)

Title

Microbiological Outcome in Participants With Baseline MRSA at EOS for mITT Population

Description

Time Frame

EOS (6 to 28 days after the last dose of study drug)

Title

Microbiological Outcome in Participants With Baseline MRSA at EOT for mITT Population

Description

Time Frame

EOT (within 72 hours of last dose of study drug)

Title

Number of Participants With Clinical Signs and Symptoms at EOT and EOS for PP Population

Description

Time Frame

EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)

Title

Number of Participants With Clinical Signs and Symptoms at EOT and EOS for mITT Population

Description

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".

Time Frame

EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)

Title

Duration of Hospital Stay for PP Population

Description

Time Frame