TR-701 FA against Linezolid for the Treatment of Nosocomial Pneumonia

• Register: SLCTR
• Last refreshed on: 29 April 2024
• Main ID: SLCTR/2015/004
• Date of registration: 2015-01-29
• Prospective Registration: Yes
• Primary sponsor: Cubist Pharmaceuticals, LLC
• Public title: TR-701 FA against Linezolid for the Treatment of Nosocomial Pneumonia
• Scientific title: A Phase 3 Randomized Double-blind Study Comparing TR-701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia
• Date of first enrolment: 2015-01-30
• Target sample size: 10 (total targeted sample size)
• Recruitment status: Complete: follow up complete
• URL: https://slctr.lk/trials/slctr-2015-004
• Study type: Interventional
• Study design: Randomized controlled trial
• Phase: Phase 3

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 Kingdo

Contacts

• Name: Dr. Asantha De Silva
• Affiliation: Consultant Anaesthetist

• Name: Dr. Asantha De Silva
• Affiliation: Consultant Anaesthetist

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients requiring IV antibiotic therapy with diagnosis of ventilated nosocomial
pneumonia

2. Gram-positive bacteria on respiratory Gram stain

3. APACHE II (Acute Physiology and Chronic Health Evaluation) score = 15

Exclusion criteria: 1. Known or suspected community-acquired bacterial pneumonia or viral, fungal, or parasitic pneumonia.

2. Structural lung abnormalities (based on clinical records)

3. Immunosuppression (based on clinical records)

4. Previous antibiotics for > 24 hours

5. Expected survival of < 72 hours


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Gram-positive Nosocomial Pneumonia in ventilated patients

Intervention(s)

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.

Primary Outcome(s)

All Cause Mortality [Within 28 days following randomization ]

Secondary Outcome(s)

All cause mortality in the Microbiological Intention to Treat (Micro-ITT) set of patients.

[At 28 days following randomization]
Compare microbiological response rates at end of treatment. [At 28 days following randomization]
Evaluate safety profile of TR-701 FA [At 28 days following randomization]
Clinical response (assessed using clinical parameters including the APACHE II score). [At 7-14 days after end of trial (EOT)]

Source(s) of Monetary Support

Cubist Pharmaceuticals, LLC

Ethics review

Status: Approved
Approval date: 25/09/2014
Contact:

[e-mail]

Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura

[phone] (Extension: 4075)

[e-mail]