Phase 3
N=726
Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)
Pneumonia
Bottom Line
View on ClinicalTrials.gov: NCT02019420 ↗Enrolled (actual)
726
Serious AEs
38.7%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population — 103; 95 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tedizolid phosphate (Drug); Linezolid (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population |
103; 95 | — |
| SECONDARY Number of Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population |
46; 49 | — |
| SECONDARY Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population |
206; 230; 144; 110; 16; 20 | — |
| SECONDARY Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population |
143; 146; 124; 97; 0; 0 | — |
| SECONDARY Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population |
31; 32 | — |
| SECONDARY Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population |
14; 20 | — |
| SECONDARY Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population |
123; 166 | — |
| SECONDARY Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population |
123; 166 | — |
| SECONDARY Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population |
117; 158 | — |
| SECONDARY Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population |
65; 74 | — |
| SECONDARY Number of Participants With ≥1 Adverse Events (AEs) |
327; 325 | — |
| SECONDARY Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE) |
4; 3 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02019420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.