Last updated on October 2017

Tedizolid Phosphate (TR-701 FA) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)


Brief description of study

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.

Detailed Study Description

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).

Clinical Study Identifier: NCT02019420

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Merck Sharp & Dohme
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Merck Sharp & Dohme IDEA, Inc.
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MSD Belgium BVBA/SPRL
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Merck Sharp & Dohme (China) Ltd.
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Merck Sharp & Dohme OU
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MSD France
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Merck Sharp & Dohme IDEA, Inc.
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MSD Sharp & Dohme GmbH
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Vianex, S.A. / MSD
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MSD CARD
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Merck Sharp & Dohme Co. Ltd.
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Merck Sharp & Dohme IDEA, Inc.
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Merck Sharp & Dohme Latvija SIA
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MSD Idea, Inc. - LB BR
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MSD
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Merck Sharp & Dohme
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MSD Ukraine LLC
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