Cefdinir versus amoxicillin/clavulanic acid in the treatment of suppurative acute otitis media in children.
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 post therapy. 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.
Adler
M
M
Belmont Health Centre, Harrow, Middlesex, UK.
McDonald
P J
PJ
Trostmann
U
U
Keyserling
C
C
Tack
K
K
D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077525:Cefdinir; D002511:Cephalosporins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D019818:Clavulanic Acid; D002969:Clavulanic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000150:complications; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010035:Otitis Media, Suppurative / Q000188:drug therapy*; D010406:Penicillins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D002969:Clavulanic Acids; D010406:Penicillins; D019818:Clavulanic Acid; D000658:Amoxicillin; D000077525:Cefdinir