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

Abstract
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.
AuthorsM Adler, P J McDonald, U Trostmann, C Keyserling, K Tack
JournalThe Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 19 Issue 12 Suppl Pg. S166-70 (Dec 2000) ISSN: 0891-3668 [Print] United States
PMID11144399 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Cephalosporins
  • Amoxicillin-Potassium Clavulanate Combination
  • Cefdinir
Topics
  • Acute Disease
  • Amoxicillin-Potassium Clavulanate Combination (administration & dosage, therapeutic use)
  • Cefdinir
  • Cephalosporins (administration & dosage, therapeutic use)
  • Child
  • Child, Preschool
  • Drug Therapy, Combination (administration & dosage, therapeutic use)
  • Female
  • Humans
  • Infant
  • Male
  • Otitis Media, Suppurative (drug therapy)
  • Treatment Outcome

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