MULTINATIONAL MULTICENTER CONTROLLED TRIAL COMPARING CEFTIBUTEN WITH CEFACLOR FOR THE TREATMENT OF ACUTE OTITIS-MEDIA

A randomized, controlled, single blind clinical trial was conducted in children with acute otitis media to evaluate the safety and efficacy of a 10-day course of therapy with ceftibuten 9 mg/kg taken as a singl e daily dose, up to a maximum daily dose of 400 mg, compared with cefa clor 40 mg/kg/day in three divided doses, up to a maximum of 1 g/day. Patients were evaluated any time from 1 to 3 days after completion of therapy (posttreatment follow-up). A total of 154 patients (106 ceftib uten, 48 cefaclor) were evaluable for efficacy. Clinical success as de termined by resolution (cure) or improvement of signs and symptoms of infection were seen in 89 and 88% of patients treated with ceftibuten and cefaclor, respectively, at the posttreatment follow-up visit. At t he extended follow-up visit (any time from 2 to 4 weeks after completi on of therapy), clinical success was sustained in 88 and 82% of the ce ftibuten-treated and cefaclor-treated patients, respectively. A total of 391 patients (264 ceftibuten, 127 cefaclor) were included in the sa fety analysis. Treatment-related adverse experiences occurred in 8% of ceftibuten treated patients and 14% of cefaclor-treated patients. All were mild or moderate and the majority were gastrointestinal. There w ere no deaths or serious adverse events. The results of this study sug gest that ceftibuten is an effective and well-tolerated alternative to other antibiotic therapies for the treatment of children with acute o titis media.