TREATMENT OF ACUTE OTITIS-MEDIA IN CHILDR EN - COMPARISON OF CEFUROXIME AXETIL AND AMOXICILLIN-CLAVULANATE SUSPENSIONS

This prospective randomised multicenter study was carried out to compa re the efficacy and safety of cefuroxime axetil suspension to those of amoxicillin/clavulanate suspension in the treatment of acute otitis m edia in children. A total of 95 children aged 6 to 36 months received 8 days of either cefuroxime axetil (46 children, 30 mg/kg,j, bid) or a moxicillin/clavulanate (49 children, 80 mg/kg.j, qid). In the intent-t o-treat analysis a successful clinical response with statistical equiv alence was observed in 98 % of cases in the cefuroxime axetil group an d in 96 % of cases in the amoxicillin/clavulanate group at the end of treatment. At the one-month follow-up visit, results were similar in b oth groups : clinical relapse in respectively 4,8 % and 2,1 % and resi dual middle ear effusion in respectively 2,3 % and 8,5 % of children i n the cefuroxime axetil group and in the amoxicillin/clavulanate group . Drug-related adverse events were reported in 4 % of children of the cefuroxime axetil group and in 12 % of children in the amoxicillin/cla vulanate group. Cefuroxime axetil (bid) is a effective as amoxicillin/ clavulanate (four times a day) in the treatment of acute otitis media in children.