Clinical Trial Details

NCT ID: NCT02019420
Date Last Changed: August 29, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating TR-701 FA IV and Linezolid for the treatment of Pneumonia

Research Study Title

A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia

Purpose

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Cubist Pharmaceuticals LLC
Duration
57 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • Requires IV antibiotic therapy with diagnosis of ventilated nosocomial pneumonia

  • Gram-positive bacteria on respiratory Gram stain

Exclusion Criteria:

  • Pneumonia of viral, fungal or parasitic etiology

  • Structural lung abnormalities

  • Immunosuppression

  • Previous antibiotics for > 24 hours

  • Expected survival of < 72 hours

Site Locations (37)

Country State City Zip Facility and Contact
United States Illinois Chicago 60611 Call for Information (Investigational Site 0111)
United States Illinois Springfield 62702 Call for Information (Investigational Site 0141)
United States Kentucky Hazard 41701 Call for Information (Investigational Site 0139)
United States Kentucky Louisville 40202 Call for Information (Investigational Site 0135)
United States Mississippi Jackson 39216 Call for Information (Investigational Site 0117)
United States Missouri Columbia 65212 Call for Information (Investigational Site 0127)
United States Ohio Cleveland 44106 Call for Information (Investigational Site 0140)
United States Ohio Lima 45801 Call for Information (Investigational Site 0104)
United States Tennessee Memphis 38103 Call for Information (Investigational Site 0119)
United States Texas Dallas 75203 Call for Information (Investigational Site 0134)
Australia North Ryde Merck Sharp & Dohme
Australian Medical Information Centre
61 2 8988 8428
Belarus Minsk Merck Sharp & Dohme IDEA, Inc.
Eran Gefen
38 (044) 393 74 80
Belgium Brussels MSD Belgium BVBA/SPRL
Marc Denayer
32 2 776 60 28
Brazil Sao Paulo MSD Brasil
MSD Online
0800 012 22 32
Canada Quebec Kirkland H9H 4M7 Merck Canada
Medical Information Centre Centre d'information medicale Merck Canada Inc.
514-428-8600 / 1-800-567-2594
China Beijing Merck Sharp & Dohme (China) Ltd.
Zaiqi Wang
+86 10 5860 9288
Czechia Prague Prague 6 MSD SRO Czech
Thomas Johansson
420 233 010 111
Estonia Tallinn Merck Sharp & Dohme OU
Katrin Moeschlin
+46 (0) 8ý578ý135 00
France Paris MSD France
Dominique Blazy
33 147548990
Georgia Tbilisi Merck Sharp & Dohme IDEA, Inc.
Eran Gefen
38 (044) 393 74 80
Germany Haar MSD Sharp & Dohme GmbH
German Medical Information Center
49 800 673 673 673
Greece Alimos Vianex, S.A. / MSD
Lazaros Poughias
30 2109897322
Guatemala Guatemala MSD CARD
Soraya Cedraro
507-282-7200
Israel Hod Hasharon Merck Sharp & Dohme Co. Ltd.
Gally Teper
972-9-9533310
Japan Chiyoda-Ku, Tokyo 102-8667 MSD K.K.
Japan Call Center
81-3-6272-1957
Kazakhstan Almaty Merck Sharp & Dohme IDEA, Inc.
Oksana Talanova
7 727 3304263
Latvia Riga Merck Sharp & Dohme Latvija SIA
Katrin Moeschlin
+46 (0) 8ý578ý135 00
Lebanon Beirut MSD Idea, Inc. - LB BR
Yehia Nabil
97144269184
Mexico Mexico City MSD
Juan Marques
52 55254819608
Peru Lima Merck Sharp & Dohme, Peru S.R.L.
Oscar Espinoza
(51-1) 411-5100
Portugal Paco Darcos Merck Sharp & Dohme Lda.
Ana Maria Nogueira
351-21-4465890
Russian Federation Moscow Merck Sharp & Dohme IDEA, Inc.
Tatiana Serebriakova
74959167100, EXT.366
Serbia Belgrade Merck Sharp & Dohme
Eran Gefen
38 (044) 393 74 80
South Africa Midrand MSD (Pty) LTD South Africa
Khanyi Mzolo
27 11 655 3140
Spain Madrid Merck Sharp and Dohme de Espana S.A.
Joaquin Mateos Chacon
(0034) 913210600
Turkey Istanbul Merck Sharp & Dohme Ilaclari Ltd. Sti
Alev Eren
90 212 336 12 63
Ukraine Kiev MSD Ukraine LLC
Eran Gefen
38 (044) 393 74 80

Contact

Toll Free Number
1-888-577-8839

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