An open-labeled and randomized trial was conducted to compare the efficacy and safety of once daily
cefpodoxime proxetil suspension (10mg/kg/day) and thrice daily
cefaclor (45mg/kg/day) in the treatment of acute
otitis media in children. A total of 57 children aged from 6 months to 9 years were enrolled; 23 were treated with
cefpodoxime and 34 with
cefaclor. Satisfactory clinical outcome, either cure or improvement, was achieved at the end of treatment in 90% of patients in the
cefaclor group and 95% of patients in the
cefpodoxime group (p > 0.05). Clinical recurrence was identified at the follow-up visits in one case of the
cefaclor group (3%), and none in the
cefpodoxime group (p > 0.05). These drugs were well tolerated by 14/21 (67%) in the
cefpodoxime-treated group and 27/32 (84%) in the
cefaclor-treated group. The incidence of adverse events was slightly higher in the
cefpodoxime group than in the
cefaclor group, however the difference did not reach statistical significance (p > 0.05). The daily cost of once-daily
cefpodoxime was lower than that of thrice-daily
cefaclor. We conclude that
cefpodoxime administered once daily is as effective and safe as
cefaclor administered thrice daily in the treatment of acute
otitis media in children. The less dosing frequency and lower daily price of
cefpodoxime provide additional benefits.