Cefdinir versus 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 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.

• Authors: M Adler, P J McDonald, U Trostmann, C Keyserling, K Tack
• Journal: European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology (Eur J Clin Microbiol Infect Dis) Vol. 16 Issue 3 Pg. 214-9 (Mar 1997) ISSN: 0934-9723 [Print] Germany
• PMID: 9131324 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Cephalosporins
• Clavulanic Acids
• Penicillins
• Clavulanic Acid
• Amoxicillin
• Cefdinir

Topics

• Amoxicillin (administration & dosage, adverse effects, therapeutic use)
• Anti-Bacterial Agents (administration & dosage, adverse effects, therapeutic use)
• Cefdinir
• Cephalosporins (administration & dosage, adverse effects, therapeutic use)
• Child
• Child, Preschool
• Clavulanic Acid
• Clavulanic Acids (administration & dosage, adverse effects, therapeutic use)
• Diarrhea (complications)
• Female
• Humans
• Infant
• Male
• Otitis Media, Suppurative (drug therapy)
• Penicillins (administration & dosage, adverse effects, therapeutic use)