Abstract
This single-blind, randomised study compared clinical outcomes for patients aged 5 months to 5 years with otitis media who were treated with either clarithromycin (7.5 mg/kg twice daily) or cefuroxime axetil (10 to 15 mg/kg twice daily) for 7 days. Demographics were comparable for the two groups. Clinical success (clinical cure, clinical cure with effusion or improvement) was observed in 96% (66 of 69) of the clarithromycin group and 94% (63 of 67) of the cefuroxime axetil recipients. Recurrence occurred in 2 clarithromycin and 4 cefuroxime patients 4 weeks post-treatment. Eleven of 77 clarithromycin-treated and 11 of 75 cefuroxime axetil-treated patients experienced adverse events. Among these only 3 patients treated with clarithromycin (4%) and 5 patients treated with cefuroxime axetil (6%) discontinued use because of adverse events, none of which were serious. Clarithromycin suspension was well tolerated and highly effective in the treatment of otitis media in children, and was comparable with cefuroxime axetil when administered for 7 days.
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