COMPARATIVE SAFETY AND EFFICACY OF CLARITHROMYCIN AND AMOXICILLIN/CLAVULANATE IN THE TREATMENT OF ACUTE OTITIS-MEDIA IN CHILDREN

Clarithromycin is a new macrolide antibiotic with a wide spectrum of activity that includes the pathogens commonly causing pediatric otitis media. This randomized, investigator-blinded, multicenter trial compared the safety and efficacy of clarithromycin and amoxicillin/clavulanate in the treatment of acute otitis media in patients ages 6 months to 12 years. A total of 338 patients with acute otitis media diagnosed by otoscopy were randomized to receive clarithromycin 7.5 mg/kg twice daily, maximum 500 mg twice daily (n = 161), or amoxicillin/clavulanate 13.3 mg/kg three times daily, maximum 500 mg three times daily (n = 177), for 10 days. Treatment groups were comparable with respect to demographics, severity of infection and number of previous episodes. Efficacy was assessed by clinical examination performed within 48 hours of finishing study medication. A successful clinical response was seen in 90% (121 of 135) of evaluable clarithromycin patients vs. 92% (133 of 145) of evaluable amoxicillin/clavulanate patients (P = 0.681). Clinical failure or relapse (Posttreatment Days O to 4) occurred in 10% (14 of 135) of clarithromycin-treated patients vs. 8% (12 of 145) of amoxicillin/clavulanate-treated patients. Gastrointestinal adverse events were the most commonly reported in both groups. Of these events diarrhea was the most frequent, occurring in 12% (19 of 161) of clarithromycin and 32% (57 of 177) of amoxicillin/clavulanate-treated patients (P < 0.001). These results indicate that the efficacy of clarithromycin oral suspension was comparable with amoxicillin/clavulanate oral suspension in the treatment of acute otitis media in children. Clarithromycin was better tolerated than amoxicillin/clavualanate with a lower incidence of gastrointestinal side effects.