At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 1,077 enrolled
Drug / intervention
linezolid +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
- ✓Male and female subjects with signs or symptoms consistent with infection
- ✓Laboratory findings consistent with staphylococcal infection (e.g., Gram stain and culture results), if available
- ✓Infection suspected to be due to Methicillin Resistant Staphylococcus Aureus
Key exclusion· 3
- ✕Previous antibiotic treatment (systemic or topical) with MRSA activity for more than 24 hours extending into the 72-hour period before first dose, unless documented treatment failure (72 hours of treatment not responding)
- ✕Uncomplicated skin infections including superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess requiring only surgical drainage
- ✕Necrotizing fasciitis, gas gangrene, or osteomyelitis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Linezolid in the Treatment of Subjects With Complicated Skin and Soft Tissue Infections Proven to be Due to Methicillin-Resistant Staphylococcus Aureus
In Brief
A Phase 4 clinical trial evaluating linezolid and vancomycin for Skin/Soft Tissue Infections and Methicillin Resistant Staphylococcus Aureus (MRSA). Completed, enrolled 1,077 participants across 126 sites in 16 countries.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belgium, Brazil, Chile, Colombia, Italy, Malaysia, Mexico, Portugal, Russia, Singapore, South Africa, Spain, United Kingdom, United States, Venezuela
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2004
Enrollment StartOct 2004
Primary CompletionJul 2007
TodayJul 2026
First PostedJul 13, 2004
Enrollment StartOct 1, 2004
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 22.0 years ago
Interventions
linezoliddrug
vancomycindrug