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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2015/004

Enrollment

Unknown

Registered

2015-01-29

Start date

2015-01-30

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gram-positive Nosocomial Pneumonia in ventilated patients

Interventions

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 t

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
All Cause Mortality [Within 28 days following randomization ]	—

Secondary

Measure	Time frame
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)]	—

Measure

Time frame

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)]

—

Countries

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,Swi

Contacts

Public ContactDr. Asantha De Silva

Consultant Anaesthetist

asanthadesilva@sltnet.lk

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026