CEFDINIR VERSUS AMOXICILLIN-CLAVULANIC ACID IN THE TREATMENT OF SUPPURATIVE ACUTE OTITIS-MEDIA IN CHILDREN

An investigator-blinded, randomized, multicenter study was conducted t o compare the efficacy and safety of cefdinir and amoxicillin/clavulan ate (amoxicillin/CA) in the treatment of pediatric patients with acute suppurative otitis media, Patients 6 months to 12 years of age were r andomized in a 1:1:1 ratio to receive cefdinir 14 mg/kg once-daily, ce fdinir 7 mg/kg b.i.d., or amoxicillin/CA 13.3 mg/kg t.i.d. Test-of-cur e was determined 11 to 16 days post therapy. Of the 752 patients who e ntered the study, 665 (88%) completed treatment and 595 (79%) were eva luable, Response rates in the three treatment groups were similar, Ove rall rates of adverse events were statistically lower in the cefdinir once-daily group than in the amoxicillin/CA group. Diarrhea was the mo st common mon adverse event in all treatment groups, Cefdinir given ei ther once-daily or twice-daily is a safe and effective treatment for p ediatric patients with acute suppurative otitis media.