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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02019420




Registration number
NCT02019420
Ethics application status
Date submitted
18/12/2013
Date registered
24/12/2013

Titles & IDs
Public title
Tedizolid Phosphate (TR-701 FA, MK-1986) vs Linezolid for the Treatment of Nosocomial Pneumonia (MK-1986-002)
Scientific title
A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia
Secondary ID [1] 0 0
TR701-132
Secondary ID [2] 0 0
1986-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tedizolid phosphate
Treatment: Drugs - Linezolid

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

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


Treatment: Drugs: Tedizolid phosphate
Tedizolid phosphate IV 200 mg once daily

Treatment: Drugs: Linezolid
Linezolid IV 600 mg twice daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With All-Cause Mortality in the Intent-to-Treat (ITT) Population
Timepoint [1] 0 0
Up to 28 days
Secondary outcome [1] 0 0
Number of Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
Timepoint [1] 0 0
Up to 28 days
Secondary outcome [2] 0 0
Clinical Response at Test of Cure (TOC) Visit in the Intent-to-Treat (ITT) Population
Timepoint [2] 0 0
7-14 days after end of therapy - TOC
Secondary outcome [3] 0 0
Clinical Response at Test of Cure (TOC) Visit in the Clinically-Evaluable (CE) Population
Timepoint [3] 0 0
7-14 days after end of therapy - TOC
Secondary outcome [4] 0 0
Number of Methicillin-Susceptible Staphylococcus Aureus (MSSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
Timepoint [4] 0 0
Up to 28 days
Secondary outcome [5] 0 0
Number of Methicillin-Resistant Staphylococcus Aureus (MRSA)-Infected Participants With All-Cause Mortality in the Microbiological Intent-to-Treat (mITT) Population
Timepoint [5] 0 0
Up to 28 days
Secondary outcome [6] 0 0
Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiological Intent-to-Treat (mITT) Population
Timepoint [6] 0 0
1-3 days after completing study therapy (Days 8-10 or Days 15-17)
Secondary outcome [7] 0 0
Number of Participants With a Favorable Response at End-of-Therapy (EOT) Visit in the Microbiologically-Evaluable 1 (ME-1) Population
Timepoint [7] 0 0
1-3 days after completing study therapy (Days 8-10 or Days 15-17)
Secondary outcome [8] 0 0
Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiological Intent-to-Treat (mITT) Population
Timepoint [8] 0 0
7-14 days after end of therapy - TOC
Secondary outcome [9] 0 0
Number of Participants With a Favorable Response at Test-of-Cure (TOC) Visit in the Microbiologically-Evaluable 2 (ME-2) Population
Timepoint [9] 0 0
7-14 days after end of therapy - TOC
Secondary outcome [10] 0 0
Number of Participants With =1 Adverse Events (AEs)
Timepoint [10] 0 0
Up to 32 days
Secondary outcome [11] 0 0
Number of Participants Discontinuing Study Therapy Due to an Adverse Event (AE)
Timepoint [11] 0 0
Up to 14 days

Eligibility
Key inclusion criteria
* Requires IV antibiotic therapy with diagnosis of ventilated nosocomial pneumonia
* Gram-positive bacteria on respiratory Gram stain
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pneumonia of community, viral, fungal or parasitic etiology
* Structural lung abnormalities
* Immunosuppression
* Previous antibiotics for > 24 hours
* Expected survival of < 72 hours

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/01/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/06/2018
Sample size
Target
Accrual to date
Final
726
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02019420