TR-701 FA against Linezolid for the Treatment of Nosocomial Pneumonia
Phase 3
- Conditions
- Gram-positive Nosocomial Pneumonia in ventilated patients
- Registration Number
- SLCTR/2015/004
- Lead Sponsor
- Cubist Pharmaceuticals, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All Cause Mortality [Within 28 days following randomization ]<br>
- Secondary Outcome Measures
Name Time Method All cause mortality in the Microbiological Intention to Treat (Micro-ITT) set of patients.<br><br> [At 28 days following randomization]<br>Compare microbiological response rates at end of treatment. [At 28 days following randomization]<br>Evaluate safety profile of TR-701 FA [At 28 days following randomization]<br>Clinical response (assessed using clinical parameters including the APACHE II score). [At 7-14 days after end of trial (EOT)]<br>