Tedizolid Phosphate (TR-701 FA) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)
| Status: | Recruiting |
|---|---|
| Conditions: | Pneumonia |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/12/2018 |
| Start Date: | January 6, 2014 |
| End Date: | August 1, 2018 |
| Contact: | Toll Free Number |
| Phone: | 1-888-577-8839 |
A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia
This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3
study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days versus
linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the treatment of
ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia
(HABP) or ventilator-associated bacterial pneumonia (VABP). Participants with concurrent
gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm.
Approximately 300 sites will participate. Ventilated participants with HABP/VABP caused by
presumed gram-positive pathogen(s) at baseline, as determined by positive Gram stain, will be
randomized 1:1 to study drug treatment.
study of tedizolid phosphate (TR-701 FA) 200 mg intravenous (IV) once daily for 7 days versus
linezolid (Zyvox®, Zyvoxid®, etc) 600 mg IV every 12 hours for 10 days for the treatment of
ventilated participants with presumed gram-positive hospital-acquired bacterial pneumonia
(HABP) or ventilator-associated bacterial pneumonia (VABP). Participants with concurrent
gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm.
Approximately 300 sites will participate. Ventilated participants with HABP/VABP caused by
presumed gram-positive pathogen(s) at baseline, as determined by positive Gram stain, will be
randomized 1:1 to study drug treatment.
The primary objective is to determine the noninferiority (NI) in all-cause mortality (ACM)
within 28 days after randomization of IV tedizolid phosphate compared with IV linezolid in
the Intent to Treat (ITT) Analysis Set in ventilated participants with presumed gram-positive
HABP or gram-positive VABP, collectively defined as ventilated nosocomial pneumonia (VNP).
within 28 days after randomization of IV tedizolid phosphate compared with IV linezolid in
the Intent to Treat (ITT) Analysis Set in ventilated participants with presumed gram-positive
HABP or gram-positive VABP, collectively defined as ventilated nosocomial pneumonia (VNP).
Inclusion Criteria:
- Requires IV antibiotic therapy with diagnosis of ventilated nosocomial pneumonia
- Gram-positive bacteria on respiratory Gram stain
Exclusion Criteria:
- Pneumonia of community, viral, fungal or parasitic etiology
- Structural lung abnormalities
- Immunosuppression
- Previous antibiotics for > 24 hours
- Expected survival of < 72 hours
We found this trial at
8
sites
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