Clinical Trial: Telithromycin in Acute Exacerbation of Chronic Bronchitis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Multicenter Non Comparative Phase IV Study on the Safety and Efficacy of Telithromycin 800 mg Per Day for 5 Days in the Treatment of Acute Exacerbation of Chronic Bronchitis
Brief Summary:
Study objectives:
- to document the clinical efficacy of telithromycin(800 mg per day for 5 days) at Test Of the Cure (TOC)visit (D12-D19), in acute exacerbation of chronic bronchitis.
- to assess the long-term clinical efficacy of telithromycin by telephone at D25-D35 (V3)
- to assess the safety of telithromycin
Detailed Summary:
Sponsor: Sanofi
Current Primary Outcome: Percentage of clinical success (cure + improvement) at TOC visit (D12-19),clinical success at TOC visit in at risk sub-populations, clinical success at follow up visit (D25-35), reinfection rates,discontinuation of treatment rates, compliance [ Time Frame: D12-D19 (efficacy assessment) and D25-D35 (telephone follow-up) ]
Original Primary Outcome:
Current Secondary Outcome: Safety assessment of telithromycin (Safety will be assessed on the basis of serious and non serious adverse events) [ Time Frame: At V3 ]
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: February 6, 2006
Date Started: January 2006
Date Completion:
Last Updated: December 8, 2009
Last Verified: December 2009
