Study start date: October 1, 2004Actual date on which the first participant was enrolled.
To determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to MRSA in adult subjects
Official TitleLinezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1077 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
How participants are assigned to different groups/arms In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.
Other Ways to Assign Participants Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision. None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
How treatments are given to participants Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.
Other Ways to Assign Treatments Single-group assignment: Everyone gets the same treatment. Cross-over assignment: Participants switch between treatments during the study. Factorial assignment: Participants receive different combinations of treatments. Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses. Other assignment: Treatment assignment does not follow a standard or predefined design.
How the interventions assigned to participants is kept confidential Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.
Other Ways to Mask Information Single-blind: Participants do not know which treatment they are receiving, but researchers do. Double-blind: Neither participants nor researchers know which treatment is given. Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given. Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
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
3 exclusion criteria prevent from participating
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives
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 Objectives
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.
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.
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 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 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 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 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).
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".
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 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 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 antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.
Duration of intravenous antibiotic treatment was measured as the number of days intravenous doses of study medication was administered, before and after discharge.
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 126 locations
Suspended
Pfizer Investigational SiteMontgomery, United StatesSee the location
Suspended
Pfizer Investigational SiteTucson, United States
Suspended
Pfizer Investigational SiteLos Angeles, United States
Suspended
Pfizer Investigational SitePalm Springs, United States