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Submitted by: Sarah Jane M. Patoc N/A Last Updated by: Sarah Jane M. Patoc 2019-10-14 10:29:44


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

PHRR140520-000197

TR701-132

2014-CT0195

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

This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3 study of TR-701 FA 200 mg 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 patients with presumed gram-positive HABP or VABP. Patients with concurrent gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm. Approximately 300 sites will participate. Ventilated patients 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

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2014-09-16 36 2017-09-16 0000-00-00

Completed

Institution Classification Region LTO #
Trius Therapeutics, Inc. Private Business United States of America
Merck Sharp & Dohme Corporation Private Business United States of America
Institution Classification Region LTO #
ICON Clinical Research Services Inc. Private Business NCR
Institution Region
Merck Sharp & Dohme Corporation United States of America
Name E-Mail Institution and Institution Address
Sarah Jane Patoc sarah.patoc@iconplc.com 24th Floor Salcedo Towers, 169 HV Dela Costa Street, Salcedo Village, Makati City, Philippines 1227
Name E-Mail Institution and Institution Address
Taylor Sandison, MD, MPH taylor.sandison@cubist.com Director of Clinical Science, 6310 Nancy Ridge Drive, Ste 105, San Diego, CA 92121
Name Expertise Affiliation
Bernice Ong-Dela Cruz, MD Pulmonology Chinese General Hospital and Medical Center
Joel M. Santiaguel, MD Pulmonology Quirino Memorial Medical Center
Lenora Cañizares-Fernandez, MD Pulmonology Philippine General Hospital
Mary Grace Dawn T. Isidro, MD Pulmonology West Visayas State University Medical Center
Mary Jane T. Sandagon, MD Pulmonology Las Piñas Doctor's Hospital, Inc.
Project Location Institutional Ethics Review Board
Chinese General Hospital and Medical Center Chinese General Hospital and Medical Center Institutional Review Board/Independent Ethics Committee
Quirino Memorial Medical Center Quirino Memorial Medical Center Hospital Ethics Committee
Philippine General Hospital Philippine General Hospital Ethics Review Board
West Visayas State University Medical Center N/A
Las Piñas Doctor's Hospital, Inc. Las Piñas Doctor's Hospital, Inc.

Pneumonia

Primary Outcome Measures: •All Cause Mortality ACM within 28 days after randomization (ITT Analysis Set)

Secondary Outcome Measures: •All Cause Mortality, Micro-ITT All Cause Mortality within 28 days after randomization (Micro-ITT Analysis Set) •Clinical Response Investigator's assessment of clinical response at TOC (ITT and CE Analysis Sets) •All Cause Mortality, MSSA/MRSA All Cause Mortality in patients with methicillin-susceptible S. aureus (MSSA) or MRSA (Micro-ITT Analysis Set) •Clinical Response, MSSA/MRSA Clinical response by Investigator in patients with MSSA or MRSA (Micro-ITT and ME-2 Analysis Sets)

Recruiting

  • Argentina
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Brazil
  • Canada
  • China
  • Colombia
  • Croatia
  • Czech Republic
  • Estonia
  • France
  • Georgia
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Israel
  • Jordan
  • Kazakhstan
  • Latvia
  • Lebanon
  • Malaysia
  • Mexico
  • New Zealand
  • Peru
  • Philippines
  • Russia
  • Serbia and Montenegro
  • Slovakia
  • South Africa
  • South Korea
  • Switzerland
  • Taiwan
  • Thailand

Clinical Trial

TR701-132

Unspecified

2014-04-15

0000-00-00

25

37

Unspecified

16 Sep 2014

Inclusion Criteria: •Patients requiring IV antibiotic therapy with diagnosis of ventilated nosocomial pneumonia •Gram-positive bacteria on respiratory Gram stain •APACHE II score ≥ 15 Exclusion Criteria: •Pneumonia of viral, fungal or parasitic etiology •Structural lung abnormalities •Immunosuppression •Previous antibiotics for > 24 hours •Expected survival of < 72 hours

Interventional

TR-701 FA IV, Linezolid

Arms: Experimental: TR-701 FA IV Drug: TR-701 FA Active Comparator: Linezolid IV Drug: Linezolid Assigned Interventions: Drug: TR-701 FA IV TR-701 FA IV 200 mg once daily for 7 days, or 14 days for bacteremia Drug: Linezolid Linezolid IV 600 mg twice daily for 10 days or 14 days for bacteremia

None

Randomized

Double Blind

Unspecified

Parallel

This is a 1:1 ratio, randomized, double-blind, double-dummy, multicenter, global Phase 3 study of TR-701 FA 200 mg 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 patients with presumed gram-positive HABP or VABP. Patients with concurrent gram-positive bacteremia are to receive 14 days of active therapy in either treatment arm.

Phase III

Utilization Utilization Info
Publication
Oral Presentation
Drug Literature
Posters
Others
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