Comparison of the efficacy and tolerability of once-daily ceftibuten and twice-daily cefprozil in the treatment of children with acute otitis media.

In this multicenter, randomized, single (investigator)-masked study, the efficacy and tolerability of once-daily ceftibuten and twice-daily cefprozil were compared in the treatment of acute otitis media in patients 6 months to 10 years of age. Ceftibuten oral suspension 9 mg/kg once daily (maximum dose, 400 mg/d) and cefprozil oral suspension 15 mg/kg twice daily (maximum dose, 1000 mg/d) were given for 10 days. Clinical response, evaluated at the posttreatment visit (days 14 to 16), was rated as clinical cure, improvement, failure, relapse/recurrence, or not assessable. The clinical response was considered successful if the posttreatment assessment was clinical cure or clinical improvement and unsuccessful if the assessment was clinical failure, relapse/recurrence, or not assessable. Tolerability was evaluated by observed and spontaneously reported adverse events. A total of 205 patients were enrolled in the study. The ceftibuten group (51 males, 51 females; mean age, 4.8 years, range, 0.5 to 10.7 years) was similar in demographic characteristics to the cefprozil group (60 males, 43 females; mean age, 4.8 years, range, 0.7 to 10.7 years). In the ceftibuten-treated group, 83.3% (85) of the 102 patients had a successful response compared with 82.5% (85) of the 103 patients in the cefprozil-treated group. The incidence of treatment-related adverse events was similar in both groups, occurring in 5.9% (6) of the ceftibuten-treated patients and 5.8% (6) of the cefprozil-treated patients. Once-daily ceftibuten oral suspension was as effective and well tolerated as twice-daily cefprozil in the treatment of acute otitis media in children. The once-daily dosing schedule for ceftibuten therapy may aid patient compliance, particularly in the pediatric population. Ceftibuten should prove to be a useful alternative in the treatment of acute otitis media.