Clinical Trial: A Multicentre, Randomised, Open-Label Study To Compare The Efficacy And Safety Of Azithromycin For 5 Days With Those Of Amoxicillin-Clavulanic Acid In Patients With Chronic Bronchitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Azithromycin (Zithromax®) 5 Days Versus Amoxicillin-Clavulanic Acid (Augmentin®): Multicentre, Randomised, Open-Label Study To Compare The Clinical Efficacy And Safety Of Azithromycin With T
Brief Summary: This study compared the clinical efficacy and safety of azithromycin with that of amoxicillin-clavulanic acid, in patients between the ages of 35 and 75 years, presenting with an exacerbation of chronic bronchitis.
Detailed Summary:
Sponsor: Pfizer
Current Primary Outcome: To assess clinical efficacy (clinical recovery or clinical failure) [ Time Frame: Day 30 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of exacerbations [ Time Frame: Day 30 to Day 90 ]
- Bacteriological monitoring (a descriptive analysis of streptococci in the bacterial flora and their sensitivity to antibiotics at the different collections of sputum) [ Time Frame: continuous ]
Original Secondary Outcome: Same as current
Information By: Pfizer
Dates:
Date Received: March 27, 2008
Date Started: October 2002
Date Completion:
Last Updated: October 20, 2008
Last Verified: October 2008
