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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
amoxicillin/clavulinic acid 500 mg/62.5 mg tablet; take 2 tablets by mouth twice daily (BID) for 10 days
Azithromycin 250 mg tablet; take 2 tablets by mouth on the first day, then 1 tablet by mouth from Days 2 to 5
To assess clinical efficacy (clinical recovery or clinical failure)
Time frame: Day 30
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
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Pfizer Investigational Site
Anzin, France
Pfizer Investigational Site
Avignon, France
Pfizer Investigational Site
Avignon, France
Pfizer Investigational Site
Dijon, France
Pfizer Investigational Site
Escaudain, France
Pfizer Investigational Site
Équeurdreville-Hainneville, France
Pfizer Investigational Site
Le Grand-Quevilly, France
Pfizer Investigational Site
Les Lilas, France
Pfizer Investigational Site
Lyon, France
Pfizer Investigational Site
Mantes-la-Jolie, France
...and 21 more locations