Efficacy and tolerability of brodimoprim in bacterial otitis media in children. Controlled study versus cefaclor.

78 pediatric patients affected by acute otitis media were selected and randomized into two balanced groups of treatment: brodimoprim, at the dosage of 200 mg once-a-day on the first day and of 100 mg once-a-day on the following days, and cefaclor at a dosage of 40 mg/Kg/day in three doses. Brodimoprim resulted more efficacious in the reduction of symptoms, especially hypoacusis and tinnitus (p < 0.05 between treatments); tympanometry showed a higher number of normalizations in the brodimoprim group, without significant differences between treatments. Both drugs resulted active against most of isolated bacterial strains. Side effects were reported in 4 patients treated with brodimoprim and in 6 patients in the control group.