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01
Overview
Phase 3, randomised, double-blind trial of tifacogin in Community-acquired pneumonia (CAP) (3 arms), sponsored by Novartis. Primary endpoint: 28-day All-Cause Mortality. Started May 2004; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Tifacogin Low Dose
Tifacogin 0.025 mg/kg/h
Tifacogin High Dose
Tifacogin 0.075 mg/kg/h
Placebo
Placebo
03
Who it enrols
Adult patients with severe community-acquired pneumonia requiring ICU admission, excluding those with high bleeding risk or recent heparin/drotrecogin alfa use.
04
Endpoints
Primary
28-day All-Cause Mortality
Secondary
90-day Survival
Adverse Events
05
Results
Not all primary endpoints met
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