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Linezolid vs vancomycin for complicated skin and soft tissue infections due to MRSA
2004-001200-12Phase 4
Key facts
- Status
- Completed
- Start
- Nov 2004
- Countries
- 1
- Sponsor
- Pfizer
- Modality
- Small Molecules
- Drugs
- linezolid
- Conditions
- Complicated skin and skin structure infection (cSSSI)
01
Overview
Phase 4, randomised trial of linezolid in Complicated skin and skin structure infection (cSSSI) (2 arms), sponsored by Pfizer. Primary endpoint: Clinical outcome at end of study in subjects with baseline MRSA. Started Nov 2004; status: completed.
02
Design
2 arms- Study design
- Randomized
Linezolid arm
Subjects receive linezolid (Zyvox) monotherapy for complicated skin and soft tissue infection due to MRSA, with optional adjunctive aztreonam or metronidazole as needed.
Vancomycin arm
Subjects receive vancomycin monotherapy for complicated skin and soft tissue infection due to MRSA, with optional adjunctive aztreonam or metronidazole as needed.
03
Who it enrols
Adult males and females with clinical signs or symptoms of complicated skin and soft tissue infection consistent with staphylococcal infection, and, when available, Gram stain and culture supporting MRSA; excludes those recently exposed to investigational drugs or linezolid studies.
04
Endpoints
Primary
Clinical outcome at end of study in subjects with baseline MRSA
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