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Cefdinir vs. amoxicillin/clavulanic acid in the treatment of suppurative acute otitis media in children

2000; Lippincott Williams & Wilkins; Volume: 19; Issue: Supplement Linguagem: Inglês

10.1097/00006454-200012001-00006

1532-0987

Michael Adler, Peter J. McDonald, Uwe Trostmann, Constance Keyserling, Kenneth J. Tack,

Bacterial Infections and Vaccines

An investigator-blinded, randomized, multicenter study was conducted to compare the efficacy and safety of cefdinir and amoxicillin/ clavulanate (amoxicillin/CA) in the treatment of pediatric patients with acute suppurative otitis media. Patients 6 months to 12 years of age were randomized in a 1:1:1 ratio to receive cefdinir 14 mg/kg once-daily, cefdinir 7 mg/kg b.i.d., or amoxicillin/CA 13.3 mg/kg t.i.d. Test-of-cure was determined 11 to 16 days posttherapy. Of the 752 patients who entered the study, 665 (88%) completed treatment and 595 (79%) were evaluable. Response rates in the three treatment groups were similar. Overall rates of adverse events were statistically lower in the cefdinir once-daily group than in the amoxicillin/CA group. Diarrhea was the most common adverse event in all treatment groups. Cefdinir given either once-daily or twice-daily is a safe and effective treatment for pediatric patients with acute suppurative otitis media.