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

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ClinicalTrials.gov Identifier: NCT02019420
Recruitment Status : Recruiting
First Posted : December 24, 2013
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Brief 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). 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.


Condition or disease Intervention/treatment Phase
Pneumonia Drug: Tedizolid phosphate IV Drug: Linezolid Phase 3

Detailed 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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 726 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia
Actual Study Start Date : January 6, 2014
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tedizolid phosphate IV
Tedizolid phosphate 200 mg IV once daily for 7 days, or 14 days for bacteremia
Drug: Tedizolid phosphate IV
Tedizolid phosphate IV 200 mg once daily
Active Comparator: Linezolid IV
Linezolid 600 mg IV every 12 hours for 10 days, or 14 days for bacteremia
Drug: Linezolid
Linezolid IV 600 mg twice daily



Primary Outcome Measures :
  1. All Cause Mortality [ Time Frame: Up to 28 days ]
    ACM within 28 days after randomization (ITT Analysis Set)


Secondary Outcome Measures :
  1. All Cause Mortality, Micro-ITT [ Time Frame: Up to 28 days ]
    ACM within 28 days after randomization (Micro-ITT Analysis Set)

  2. Clinical Response [ Time Frame: 7-14 days after end of therapy (EOT) ]
    Clinical response at Test of Cure (TOC)

  3. All Cause Mortality, MSSA/MRSA [ Time Frame: Up to 28 days ]
    ACM in participants with methicillin-susceptible Staphylococcus aureus (MSSA) or methicillin-resistant Staphylococcus aureus (MRSA) (Micro-ITT Analysis Set)

  4. Clinical Response, MSSA/MRSA [ Time Frame: 7-14 days after EOT ]
    Clinical response by Investigator in participants with MSSA or MRSA (Micro-ITT and ME-2 Analysis Sets)

  5. Microbiological response [ Time Frame: 7-14 days after EOT ]
    Microbiological response at EOT and TOC (Micro-ITT, ME-1, and ME-2 Analysis Sets)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019420


Contacts
Contact: Toll Free Number 1-888-577-8839

  Show 28 Study Locations
Sponsors and Collaborators
Cubist Pharmaceuticals LLC
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications:

Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT02019420     History of Changes
Other Study ID Numbers: 1986-002
TR701-132 ( Other Identifier: Cubist Protocol Number )
2013-004154-22 ( EudraCT Number )
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Cubist Pharmaceuticals LLC:
Pneumonia
Tedizolid Phosphate
TR-701

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Linezolid
Torezolid phosphate
Torezolid
Oxazolidinones
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action