Phase 3 Study in Ventilated Gram Positive Nosocomial Pneumonia
Research type
Research Study
Full title
A Phase 3 Randomised Double-Blind Study Comparing TR-701FA and Linezolid in Ventilated Gram-Positive Nosocomial Pneumonia
IRAS ID
146386
Contact name
Mark Bellamy
Contact email
Sponsor organisation
Cubist Pharmaceuticals Inc
Eudract number
2013-004154-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 4 months, 0 days
Research summary
Pneumonia is a common type of lung infection that can cause cough, shortness of breath, fever,chest pain and other symtoms. Ventilator Associated Bacterial Pneumonia (VABP) occurs when people get pneumonia while receiving mechanical ventilation in the hospital. Hospital Acquired Bacterial Pneumonia (HABP) is another type of pneumonia that develops while a patient is in the hospital.
This study will investigate how effective and safe TR701 - FA (tedizolid phosphate) compared to Linezolid (standard antibiotic) is in the treatment of HABP or VABP. No standard medical treatment will be withheld for any of the participants.
HABP is the most common cause of death among nosocomial infections and is the primary cause of death in intensive care units.
Patients with VABP have longer durations of mechincal ventilation and spend more time in the hospital.
This research will provide valuable information to medics for future treatment of HABP and VABP.
Once eligibility has been confirmed (during screening), participants will receive either Tedizolid Phosphate (200mg) or Linezolid (600mg). Both are given by IV infusion. All participants will receive one of the study drugs and a placebo.
Depending on whether or not bacteria is present in the participants blood, study drug will be administered for either 10 or 14 days. If required, the study doctor may also prescribe additional antibiotics to ensure different types of bacteria are targeted.
The Investigator, his study team and medical staff involved in the participants care and/or clinical evaluations will remain blinded to the treatment assignment for the duration of the study.
The overall study time for study participation is a maximum of 32 days, excluding the screening visit (within 24 hours before the first infusion).
The study will recruit 726 adult male and female participants at approximatley 300 research centres across the world.
The study is being funded by Trius Therapeutics, a wholly owned subsidiary of Cubist Pharmaceuticals Inc.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
15/YH/0010
Date of REC Opinion
30 Mar 2015
REC opinion
Further Information Favourable Opinion