A COMPARATIVE-STUDY OF CLARITHROMYCIN AND AMOXICILLIN SUSPENSIONS IN THE TREATMENT OF PEDIATRIC-PATIENTS WITH ACUTE OTITIS-MEDIA

This phase III, single-blind, randomized, multicentre clinical trial c ompared the safety and efficacy of clarithromycin and amoxycillin in t he treatment of otitis media in pediatric patients. Two hundred and fi fty-nine patients aged 1-12 were prescribed suspensions of clarithromy cin (132 patients) or amoxycillin (127 patients). Both suspensions wer e prescribed at a dose of 125 mg for children weighing less that 25 kg or at 250 mg for children weighing more than 25 kg, but three doses o f amoxycillin per day were given, while only two doses clarithromycin per day were required. Each drug was administered for approximately 5 days. Clinical evaluations were performed pre-treatment (Study Day 1), at the end of treatment (Study Days 6-9), and post-treatment (Study D ays 28-32). At the end of treatment, 91 out of 114 evaluable patients (80%) had clinical cures with clarithromycin, while 71 out of 105 eval uable patients (68%) had clinical cures with amoxycillin (p = 0.057). Clinical success rates were 96% for both treatments (110/114, clarithr omycin; 101/105 amoxycillin). Adverse events related to the study medi cations occured in four of 132 patients receiving clarithromycin (3%) and eight out of 127 subjects receiving amoxycillin (6%). Three patien ts discontinued treatment due to adverse events, all three receiving a moxycillin. At the doses administered, clarithromycin given twice-dail y was as safe and effective as amoxycillin given three-times-daily in the treatment of acute otitis media in pediatric patients.