74 children with acute otitis media (AOM) were entered into an observer-blind randomised multicentre general practice study to compare the efficacy and safety of the new third generation oral cephalosporin, cefetamet pivoxil, at a dose of 10 mg/kg twice daily with the efficacy and safety of cefaclor 10 mg/kg twice daily administered for 10 days.
Of 36 evaluable patients in the cefaclor treatment group, 28 (78%) were cured, and a further 4 were improved, giving an overall efficacy rate (cure/improvement) of 89%. Of 36 evaluable patients in the cefetamet pivoxil treatment group, 31 (86%) were cured, and a further 4 were improved, giving an overall efficacy rate of 97%. Adverse events were reported in 4 patients: 1 cefaclor recipient and 3 patients in the cefetamet pivoxil treatment group. Diarrhoea, the most frequently observed adverse event, occurred in both treatment groups.
The study results indicate that cefetamet pivoxil and cefaclor appear to have similar efficacy and safety in the treatment of AOM in children.