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Tedizolid vs Linezolid in Ventilated Gram-positive Nosocomial Pneumonia
NCT02019420Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2014
- Primary completion
- Jun 2018
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- tedizolid
- Conditions
- hospital-acquired bacterial pneumonia (HAP)ventilator-associated pneumonia (VAP)
01
Overview
Phase 3, randomised, double-blind trial of tedizolid in hospital-acquired bacterial pneumonia (HAP) and ventilator-associated pneumonia (VAP) (2 arms), sponsored by Merck & Co. Primary endpoint: All-Cause Mortality at 28 days. Started Jan 2014; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tedizolid phosphate IV
Tedizolid phosphate 200 mg IV once daily
Linezolid IV
Linezolid 600 mg IV every 12 hours
03
Who it enrols
Patients with ventilated nosocomial pneumonia (HABP/VABP) and gram-positive bacteria on respiratory Gram stain. Excludes community/viral/fungal/parasitic pneumonia, structural lung abnormalities, immunosuppression, and those with expected survival < 72 hours.
04
Endpoints
Primary
All-Cause Mortality
Secondary
Clinical Response at Test of Cure
Adverse Events
05
Results
Primary endpoints met
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