Double-blind comparison of cefixime and cefaclor in the treatment of acute otitis media in children

In a double-blind study cefixime, an oral cephalosporin of the third generation, was compared to cefaclor in the treatment of acute otitis media in 397 children aged 6 months to 12 years. Clinical evaluation was carried out at the beginning, at day 10–12 and day 28–35 after the start of the treatment. Specimens for bacterial culture and sensitivity testings were taken from the nasopharynx at the initial visit. Patients were randomized either to cefixime in a dose of 8 mg/kg/day or cefaclor in a dose 40 mg/kg/day in the proportion of 2 cefixime patients to 1 cefaclor patient. Two daily doses were administered for 7 days. At day 10–12, 93.5% in the cefixime group and 90.5% in the cefaclor group (p=0.08) were clinically cured or improved. At day 28–35 the rate of cured or improved patients had decreased, mostly due to reinfections, to 90.1% in the cefixime group and to 86.6% in the cefaclor group (p=0.12), respectively. 375 patients (69.9%) had positive bacterial culture in the nasopharynx of at least one st...