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Telithromycin vs Azithromycin in CAP (COBRA II)
NCT00237445Phase 4
Key facts
- Status
- Terminated
- Start
- Nov 2005
- Primary completion
- Sep 2006
- Countries
- 1
- Sponsor
- Sanofi
- Modality
- Covalent Small Molecules, Classical Binding Small Molecules, Nucleic Acid-Directed Small Molecules
- Drugs
- telithromycin
- Conditions
- community acquired pneumonia (CAP)
01
Overview
Phase 4, randomised, double-blind trial of telithromycin in community acquired pneumonia (CAP) (2 arms), sponsored by Sanofi. Primary endpoint: Clinical Cure Rate at Test of Cure Visit. Started Nov 2005; status: terminated.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Telithromycin
Telithromycin 800 mg once daily for 7 days
Azithromycin
Azithromycin 500 mg once daily for 5 days
03
Who it enrols
Adult outpatients (>=20 years) with mild to moderate CAP, excluding those with severe renal impairment, myasthenia gravis, long QT syndrome, or requiring hospitalization.
04
Endpoints
Primary
Clinical Cure Rate at Test of Cure Visit
Secondary
Clinical Efficacy at End of Therapy
Bacteriological Efficacy
Health Outcomes
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