DOUBLE-BLIND AND OPEN-LABEL STUDIES OF AZITHROMYCIN IN THE MANAGEMENT OF ACUTE OTITIS-MEDIA IN CHILDREN - A REVIEW

One noncomparative and three comparative multicenter studies were conducted in the United States to assess the efficacy and safety of azithromycin for the treatment of acute otitis media in 1220 evaluable children. Clinical cure rates of up to 87.5% were reported for azithromycin in all trials, In the comparative trials, clinical cure rates for amoxicillin/clavulanate were not significantly different from those for azithromycin, Bacteriologic eradication, including betalactamase-positive organisms, occurred in over 75% of patients treated with azithromycin or with amoxicillin/clavulanate in the comparative trials, In each comparative trial, azithromycin produced a significantly lower incidence of treatment-related side effects than amoxicillin/clavulanate. Azithromycin was highly effective in the treatment of acute otitis media in children, with clinical cure and bacteriologic eradication rates comparable to those of amoxicillin/clavulanate. Azithromycin, however, was significantly better tolerated. Moreover, azithromycin has a relatively simple once daily B-day dosage regimen therapeutically equivalent to a 10-day amoxicillin/clavulanate dosage regimen, a pleasant taste and no food or refrigeration requirements.