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

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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.

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).

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
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North Ryde, 2113
Phone: 61 2 8988 8428
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