A general practice comparative study of a new third-generation oral cephalosporin, cefixime, with amoxycillin in the treatment of acute paediatric otitis media.

A total of 325 eligible paediatric patients were entered into an open, randomised, multicentre general practice study to assess the comparative efficacy of a new third-generation oral cephalosporin, cefixime, with respect to that of amoxycillin in the treatment of acute otitis media. The dose of cefixime was 100 mg once daily (six months to five years), 200 mg once daily (five to 10 years) and 300 mg once daily (10 to 16 years). The dose of amoxycillin was as currently used by the participating general practitioners: 62.5 mg tds (six months to one year), 125 mg tds (one to seven years) and 250 mg tds (seven to 16 years). Both were in the form of an oral suspension. The two groups (160 patients on cefixime and 165 on amoxycillin) were comparable at study entry with respect to all parameters assessed. Overall there was a 95 per cent favourable clinical response seen in both groups (95 per cent confidence limits: 92 and 98 per cent respectively). Adverse events were comparable in both groups, except that there were more gastrointestinal side effects seen with cefixime (13 per cent) compared with amoxycillin (4 per cent), but only three patients in each group had to be withdrawn because of side effects. These results demonstrate that cefixime given once daily is a safe and effective alternative to amoxycillin in the treatment of acute otitis media in children, and also has the advantage of less frequent dosing.