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 single daily dose, up to a maximum daily dose of 400 mg, compared with
cefaclor 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
ceftibuten, 48
cefaclor) were evaluable for efficacy. Clinical success as determined 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 the extended follow-up visit (any time from 2 to 4 weeks after completion of
therapy), clinical success was sustained in 88 and 82% of the
ceftibuten-treated and
cefaclor-treated patients, respectively. A total of 391 patients (264
ceftibuten, 127
cefaclor) were included in the safety 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 were no deaths or serious adverse events. The results of this study suggest that
ceftibuten is an effective and well-tolerated alternative to other
antibiotic therapies for the treatment of children with acute
otitis media.