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

The safety and efficacy of clarithromycin was compared with those of a moxicillin-potassium calvulanate for the treatment of acute otitis med ia in children. In a multicenter, randomized, investigator-blinded tri al, 180 patients (6 months to 12 years of age) with acute otitis media were allocated to receive either clarithromycin, 15 mg/kg in two divi ded doses (n = 90), or amoxicillin-clavulanate, 40 mg/kg in three divi ded doses (n = 90), for 10 days. Middle ear samples were obtained by t ympanocentesis from 175 of 180 patients. Pathogens were isolated from 137 samples (76%). Eighty-six patients in each treatment group were co nsidered for efficacy analysis. Clinical cure or improvement was achie ved within 4 days after treatment in 80 (93%) of 86 patients receiving clarithromycin and in 82 (95%) of 86 patients receiving amoxicillin-c lavulanate. Recurrence of infection was observed between 5 and 35 days after treatment in 9 (11%) of 80 patients in the clarithromycin group and in 8 (10%) of 82 patients in the amoxicillin-clavulanate group. M iddle ear effusion was found with similar frequency at the end of ther apy and at follow-up visits in both treatment groups. Mild gastrointes tinal signs and symptoms, the most common side effects, were noted in 20% and 52% of patients in the clarithromycin group and the amoxicilli n-clavulanate group, respectively (p <0.001). We conclude that clarith romycin is a safe and effective antimicrobial agent for the treatment of acute otitis media in children.