At a glance
ClinicalIndex Comparison Record- ✓Hospitalized patients with clinically documented nosocomial pneumonia proven due to methicillin-resistant Staphylococcus aureus (MRSA)
- ✓Chest X-ray at baseline/screen or within 48 hours of treatment consistent with pneumonia diagnosis
- ✓Suitable sputum specimen: <10 squamous epithelial cells AND ≥25 leukocytes, or culture obtained by invasive technique within 24 hours of study entry
- ✕Prior antibiotic with MRSA activity (other than linezolid or vancomycin) for >48 hours, unless documented treatment failure (≥72 hours treatment without response)
- ✕Severe neutropenia (<500 cells/mm³)
- ✕Hypersensitivity to oxazolidinones or vancomycin
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Linezolid In The Treatment Of Subjects With Nosocomial Pneumonia Proven To Be Due To Methicillin-Resistant Staphylococcus Aureus
In Brief
A Phase 4 clinical trial evaluating linezolid (Zyvox) and vancomycin for Methicillin Resistant Staphylococcus Aureus (MRSA). Completed, enrolled 1,225 participants across 177 sites in 22 countries.
Detailed Summary
To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.
Study Details
Timeline
Interventions
Subjects to receive either linezolid 600 mg IV (Intravenous) or PO (orally) q 12 h (every 12 hours) for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.
Subjects to receive vancomycin 15mg/kg IV (Intravenous) q12h (every 12 hours), adjusted for renal function, for 7-14 days, except in cases of documented bacteremia where it could be extended to 21 days based upon investigator's discretion.