EFFICACY AND TOLERANCE OF THE JOSAMYCIN 5 OR 10 DAYS VERSUS AZITHROMYCIN 5 DAYS IN THE TREATMENT OF ACUTE BRONCHITIS IN ADULTS

This open-label, multicenter trial compared the clinical effectiveness and the safety of 5 - or 10 - day treatment with new form of josamyci n (JOS), dispersible tablet containing 1 g of josamycin, 2 g/day b.i.d ., to those of azithromycin (AZI) 500 mg once a day the first day and 250 mg/day for 4 days in the treatment of adults with acute bronchitis . An intention - to - treat - analysis of clinical efficacy was perfor med for 523 patients at the end of treatment (day 7 or day 12) and for 466 patients at the follow-up visit (day 30). Five hundred twenty one patients were analysed for safety. At the end of treatment, the rate of successful clinical responses was of 90.2 % (157/174) in 5 - day JO S group, of 91.4 % (160/175) in 5 day AZI group and of 92.5 % (161/174 ) in 10 - day JOS group. At the follow-up visit, clinical relapses occ ured in 2/152 (1.3 %) patients in 5 - day JOS group, in 3/158 (1.9 %) in 5 - day AZI group and in 38/173 patients in 10 - day JOS group (p = 0.12). The number of patients with side effects was 30/173 (5 - day J OS), 24/175 (5 - day AZI) and 38/173 (10 - day JOS). Ten patients stop ped the treatment in relation to side-effects. The clinical effectiven ess and the safety of 5 - day course of josamycin or of 10 - day cours e of josamycin were equivalent to that of 5 - day course of azithromyc in.