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NXL103 in Community-Acquired Pneumonia
NCT00653172Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2007
- Primary completion
- Jun 2008
- Countries
- 9
- Sponsor
- Novexel
- Conditions
- community acquired pneumonia (CAP)
01
Overview
Phase 2, randomised, double-blind trial of flopristin + linopristin in community acquired pneumonia (CAP) (3 arms), sponsored by Novexel. Primary endpoint: Clinical outcome at 21 days. Started Oct 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
NXL103 500mg
NXL103 500mg orally twice daily
NXL103 600mg
NXL103 600mg orally twice daily
Active Comparator
Amoxicillin/Clavulanate twice daily
03
Who it enrols
Adults with community-acquired pneumonia, excluding severe cases, those with concomitant pulmonary disease, or those with hypersensitivity to macrolides or beta-lactams.
04
Endpoints
Primary
Clinical outcome
Secondary
Bacteriological outcome
Safety and tolerance
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