Cefixime is a new oral cephamycin antibiotic with a broad spectrum of antibacterial activity in vitro. It is resistant to hydrolysis by most beta-lactamases and has pharmacokinetic characteristics which allow administration in a single daily dose for the treatment of some bacterial infections. The aim of this study was to compare the clinical efficacy of cefixime with that of amoxicillin in the treatment of acute otitis media in 40 children. Cefixime 8 mg/kg was given once daily at bedtime, whereas amoxicillin 50 mg/kg/day was administered in 3 divided doses; both drugs were given for 10 days. 15 days after starting the trial, a favourable clinical response was demonstrated in 18 of 20 children in both treatment groups. Cure rates, recurrences and persistent middle ear effusions were not significantly different in the 2 study groups during a 3-month follow-up. It was concluded that cefixime is clinically effective and well tolerated in the treatment of children with acute otitis media.