To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,077
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.
Time frame: EOS (6 to 28 days after the last dose of study drug)
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.
Time frame: EOT (within 72 hours of last dose of study drug)
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.
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Pfizer Investigational Site
Montgomery, Alabama, United States
Pfizer Investigational Site
Tucson, Arizona, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Palm Springs, California, 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
Sylmar, California, United States
Pfizer Investigational Site
Torrance, California, United States
Pfizer Investigational Site
Torrance, California, United States
...and 116 more locations
Time frame: EOS (6 to 28 days after the last dose of study drug)
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.
Time frame: EOT (within 72 hours of last dose of study drug)
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).
Time frame: EOS (6 to 28 days after the last dose of study drug)
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).
Time frame: EOT (within 72 hours of last dose of study drug)
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).
Time frame: EOS (6 to 28 days after the last dose of study drug)
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).
Time frame: EOT (within 72 hours of last dose of study drug)
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".
Time frame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)
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".
Time frame: EOT (within 72 hours of last dose of study drug), EOS (6 to 28 days after the last dose of study drug)
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.
Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
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.
Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
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.
Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
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.
Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)
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.
Time frame: Baseline up to EOS (6 to 28 days after the last dose of study drug)