Cefetamet pivoxil in otitis media.

In this multicentre, open, randomized, parallel-group study, 270 children with acute otitis media aged between 1 and 15 years were randomized to receive either cefetamet pivoxil 10 mg/kg b.i.d. for 7 days (n = 134) or cefaclor 13.5 mg/kg t.i.d. for 7 days (n = 136). At the end of treatment, bacteriological cure occurred in 44/44 (100%) patients receiving cefetamet pivoxil and 24/28 (86%) patients receiving cefaclor. Clinical cure or improvement was experienced by 117/121 (97%) of patients receiving cefetamet pivoxil and 104/115 (90%) patients in the cefaclor group. Adverse side effects, mainly gastrointestinal disorders, occurred in 11% of patients in the cefetamet pivoxil group compared with 15% of patients in the cefaclor group. All adverse events were of mild or moderate severity and subsided rapidly after treatment. Premature treatment withdrawals occurred in 0.7% of patients who received cefetamet pivoxil and in 2.2% of those who received cefaclor.

RCT Entities:   Population Interventions Outcomes