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

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 3

Conditions: Pneumonia

Treatments: Drug: Tedizolid phosphate; Drug: Linezolid

Study type: Interventional

Funder types: Industry

Identifiers

NCT02019420

TR701-132 (Other Identifier)

1986-002

MK-1986-002 (Other Identifier)

2013-004154-22 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 726 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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726 participants in 2 patient groups

Tedizolid phosphate IV

Experimental group

Description:

Ventilated HABP/VABP participants receive tedizolid phosphate 200 mg IV once daily for 7 days, or for 14 days for concurrent bacteremia.

Treatment:

Drug: Tedizolid phosphate

Linezolid IV

Active Comparator group

Description:

Ventilated HABP/VABP participants receive linezolid 600 mg IV every 12 hours for 10 days, or for 14 days for concurrent bacteremia.

Treatment:

Drug: Linezolid