ACUTE OTITIS-MEDIA IN ADULTS - A COMPARATIVE-STUDY OF CEFOTIAM HEXETIL AND AMOXICILLIN-CLAVULANIC ACID EFFICACY

This study compared the clinical efficacy and safety of cefotiam hexet il (CTM) 200 mg bid with those of amoxicillin/clavulanic acid (AMC) 1 g bid for 10 days. 189 ambulatory adult patients suffering from acute otitis media were included by ENT specialists in this multicenter pros pective randomized double blind study. Otitis was diagnosed according to an association of clinical and otoscopic signs, either in collectio n stage (CS) - otalgia, fever, and red bulging tympanum - or in sponta neous perforation stage (SPS) - otalgia, fever, otopyorrhea for less 4 8 hours. The possible confusion at inclusion between indisputable acut e otitis media and external otitis was avoided in taking into account the bacteriological results of the otorrhea culture,Thus, only 66 pati ents were used to determine the epidemiologic profile of acute otitis media in adults. 177 patients were evaluated for efficacy analysis (88 and 89 respectively in CTM and AMC groups). Population for both regim ens was comparable at inclusion according to demographic and clinical data. The overall clinical success rate at the end of treatment was no t significantly different between the 2 groups in Intent to Treat anal ysis (CTM 94 % versus AMC 90 %) but became statistically significant i n Per Protocol analysis (CTM 97 % versus AMC 90 %; p = 0.04), The inci dence of patients with adverse events was comparable in both groups (C TM 14 % versus AMC 10 %). The efficacy of both treatments was comparab le for all the patients included and also for the patients with an ind isputable acute otitis media.