Five-day therapy with cefpodoxime versus ten-day treatment with cefaclor in infants with acute otitis media

The aim of this open randomized multicenter study was to compare the efficacy and safety of a 5-day treatment with cefpodoxime with a 10-day treatment with cefaclor in acute otitis media in infancy (dosage of cefpodoxime: > 3 months - 2 years 40 mg/b.i.d.; > 2-6 years 60 mg/b.i.d.; dosage of cefaclor: 40 mg/kg/day in three doses). In two of the 100 patients included the therapy was discontinued early because of diarrhoea in one infant in the cefpodoxime group and because of poor acceptance by one infant in the cefaclor group. The clinical efficacy was 100% in both groups. Poor acceptance was found in 2% of the patients in the cefpodoxime group and in 4% in the comparative group. Adverse reactions (diarrhoea inmost cases) were observed in 10% of the patients in the cefpodoxime group and in 8% in the cefaclor group. At the follow-up visit 3 weeks after the end of treatment a relapse rate of 12.5% and of 8.3% was found in the cefpodoxime and the cefaclor group, respectively (difference not statistically significant). Cefpodoxime seems to be a suitable drug for a 5-day treatment of acute otitis media in infants.