Pneumonia Clinical Trial
Official title:
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), collectively referred to as
ventilated nosocomial pneumonia (VNP). Participants with concurrent gram-positive bacteremia
are to receive 14 days of active therapy in either treatment arm.
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 (NI is declared when the lower bound of the 95% CI >
-10).
n/a
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