Comparative Safety and Efficacy of Clarithromycin and Azithromycin Suspensions in the Short Course Treatment of Children with Acute Otitis Media

Abstract

The safety and efficacy of short course treatment with a new oral suspension formulation of clarithromycin was evaluated in this multicentre, phase III, open comparative trial in 153 children aged 5 months to 6 years with signs and symptoms of acute otitis media. Children were randomised to receive a 5-day course of clarithromycin oral suspension (7.5 mg/kg; maximum 500mg) twice daily or azithromycin oral suspension (10 mg/kg on day 1, followed by 5 mg/kg daily for 4 days) once daily. Specific clinical response criteria were developed based on pretreatment signs and symptoms. Of the 153 patients enrolled, 147 patients (96%) were evaluable (clarithromycin, 72; azithromycin, 75). There were no demographic differences between the two groups. Clarithromycin and azithromycin suspensions were similarly effective for the treatment of acute otitis media. Clinical success (cure, cure with effusion, or improvement) was achieved in 99% of both clarithromycin- and azithromycin-treated patients. Both drugs were well tolerated; adverse events considered probably drug related were reported by 10 (13%) of clarithromycin recipients and 11 (14%) of azithromycin recipients. There were no significant differences between the groups in the numbers of patients reporting events that were thought to be related to study medication. A 5-day regimen of clarithromycin suspension (7.5 mg/kg twice daily) appears to be as safe and effective as a 5-day regimen of azithromycin suspension for the treatment of acute otitis media in children.