Home » Trials » SLCTR/2015/004
A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia
-
SLCTR Registration Number
SLCTR/2015/004
Date of Registration
The date of last modification
Mar 03, 2019
View original TRDS
Trial Status
Scientific Title of Trial
A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia
Public Title of Trial
TR-701 FA against Linezolid for the Treatment of Nosocomial Pneumonia
Disease or Health Condition(s) Studied
Gram-positive Nosocomial Pneumonia in ventilated patients
Scientific Acronym
None
Public Acronym
None
Brief title
TR-701 FA against Linezolid for the Treatment of Nosocomial Pneumonia
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EUCTR2013-004154-22-LV, ClinicalTrials.gov Identifier: NCT02019420
What is the research question being addressed?
Is intravenous TR-701 FA non-inferior to intravenous linezolid in reducing all cause mortality in patients with ventilated nosocomial pneumoniawithin 28 days after randamoization?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Active
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
The study will be carried out in the following centers: a. Colombo North Teaching Hospital b. Teaching Hospital Kandy c. Teaching Hospital Peradeniya
Consenting participants will be randomized into two arms:
Arm 1: TR-701 FA 200 mg IV infusion once daily for seven days in presumed hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).
Arm 2: Linezolid 600 mg IV infusion twice daily for 10 days in presumed hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP).
Patients with concurrent gram-positive bacteremia will receive treatment for 14 days in either treatment arm.
This is an active comparator study. However, a placebo unique to each active treatment will be used in both arms to mask the intervention / ensure blinding (double-dummy technique).
Baseline therapy offered to patients to will be standard of care used at study sites based on physician discretion. Other antibiotics may be used based on physician judgment. If indicated, following antibiotics are preferred for Gram (-) coverage depending on standard practice at each site: First line: aztreonam +/- colistin Second line: ceftriaxone, levofloxacin, imipenem, cefepim, etc
End of treatment management in both arms will be the same.
Inclusion criteria
Patients requiring IV antibiotic therapy with diagnosis of ventilated nosocomial pneumonia
Gram-positive bacteria on respiratory Gram stain
APACHE II (Acute Physiology and Chronic Health Evaluation) score = 15
Exclusion criteria
Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia.
Structural lung abnormalities (based on clinical records)
Immunosuppression (based on clinical records)
Previous antibiotics for > 24 hours
Expected survival of < 72 hours
Primary outcome(s)
|
1.
All Cause Mortality |
[ Within 28 days following randomization ] |
Secondary outcome(s)
|
1.
All cause mortality in the Microbiological Intention to Treat (Micro-ITT) set of patients. |
[ At 28 days following randomization ] |
|
2.
Compare microbiological response rates at end of treatment. |
[ At 28 days following randomization ] |
|
3.
Evaluate safety profile of TR-701 FA |
[ At 28 days following randomization ] |
|
4.
Clinical response (assessed using clinical parameters including the APACHE II score). |
[ At 7-14 days after end of trial (EOT) ] |
Target number/sample size
10 (total targeted sample size)
Countries of recruitment
Austria, Belarus, Belgium, Croatia, Czech Republic, Estonia, France, Georgia, Germany, Greece, Hungary, Israel, Jordan, Kazakhstan, Latvia, Lebanon, Russian Federation, Serbia, Slovakia, South Africa, Spain, Sri Lanka, Switzerland, Turkey, Ukraine, United Kingdom, United States
Anticipated start date
2015-01-30
Anticipated end date
2018-07-31
Date of first enrollment
2015-12-04
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Cubist Pharmaceuticals, LLC
Regulatory approvals
Approved (MTS/CP/P4/CT22/2014)
Status
Approved
Date of Approval
2014-09-25
Approval number
45/14
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Asantha De Silva
Consultant Anaesthetist
University Department of Obstetrics & Gynaecology,
Colombo North Teaching Hospital,
Ragama
+94777559858
asanthadesilva@sltnet.lk
Contact Person for Public Queries
Dr. Asantha De Silva
Consultant Anaesthetist
University Department of Obstetrics & Gynaecology,
Colombo North Teaching Hospital,
Ragama
+94777559858
asanthadesilva@sltnet.lk
Primary study sponsor/organization
Cubist Pharmaceuticals, LLC
2000, Galloping Hill Road
Kenilworth, New Jersey
http://www.cubist.com/research-and-development
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
