COMPARISON OF CEFPODOXIME PROXETIL AND CEFIXIME IN THE TREATMENT OF ACUTE OTITIS-MEDIA IN INFANTS AND CHILDREN

Objective. To compare the use of once-a-day cefpodoxime proxetil to on ce-a-day cefixime in the treatment of acute suppurative otitis media. Design. Randomized, multicenter, investigator-blinded. Setting. Outpat ient. Patients. A total of 368 patients (age 2 months to 17 years) wer e randomized to receive either cefpodoxime or cefixime in a 2:1 ratio (245 cefpodoxime, 123 cefixime); 236 patients (155 cefpodoxime, 81 cef ixime) were evaluable for drug efficacy. Interventions. Patients recei ved either cefpodoxime proxetil oral suspension (10 mg/kg/day, once da ily for 10 days) or cefixime oral suspension (8 mg/kg/day, once daily for 10 days). Main outcome measures. Clinical evaluations were perform ed before treatment (study day 1), at an interim visit (study day 3 th rough 6), at the end of therapy (study day 12 through 15), and at fina l follow-up (study day 25 through 38). Microbiologic evaluations were performed at enrollment and whenever appropriate thereafter. Results. End-of-therapy clinical cure rates in evaluable patients were 56% for the cefpodoxime group and 54% for the cefixime group. Clinical improve ment rates were 27% for both groups. Clinical response rates were not significantly different between treatment groups (P =.541; 95% confide nce interval = -8.1%, 15.2%). At long-term follow-up, 17% of patients in the cefpodoxime group and 20% in the cefixime group had a recurrenc e of infection. Drug-related adverse events (eg, diarrhea, diaper rash , vomiting, rash) occurred in 23.3% of cefpodoxime-treated patients an d 17.9% of cefixime-treated patients (P =.282). Conclusions. These fin dings suggest that cefpodoxime proxetil administered once daily is as effective and safe as cefixime given once daily in the treatment of ac ute suppurative otitis media in pediatric patients.