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

• Status: Completed
• Trial end date: 2018-06-22
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Linezolid; Tedizolid; Tedizolid phosphate; Torezolid phosphate

Criteria

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