Comparative trial of 3-day azithromycin versus 10-day amoxycillin clavulanate potassium in the treatment of children with acute otitis media with effusion

A randomized, open clinical trial was performed to compare azithromycin and amoxycillin/clavulanate potassium in children with acute otitis media with effusion. Patients were allocated to therapy with azithromycin (10 mg/kg once daily for 3 days) or amoxycillin/clavulanate potassium (40 mg/kg/day divided into three equal doses for 10 days). Clinical examination and tympanometric evaluation were performed at baseline, and at day 3 to 5, day 10 to 14, day 28 to 30 and day 55 to 60 after the initiation of therapy. Tympanocentesis fluid cultures were collected at enrolment, and urine and blood samples were obtained at baseline and at day 10 to 11. Of 100 patients enrolled, 92 were considered evaluable. Middle ear cultures were positive in 53.2% of the patients; the most common pathogens were Streptococcus pneumoniae (33%) and Haemophilus influenzae (33 %). The response was satisfactory in 47 (100%) patients treated with azithromycin and 42 (95.4%) patients receiving AVC. Rates of persistence of middle ear effusion were comparable. Nausea and loose stools were more common in children treated with amoxycillin/clavulanate potassium (P less than or equal to 0.02). Based on the comparable efficacy noted in this study, the lower incidence of side-effects and the convenience of a shorter duration of treatment, azithromycin represents an attractive therapeutic alternative to amoxycillin/clavulanate potassium and should be further evaluated in larger-scale clinical trials including patients with penicillin-resistant organisms.