Multicentre comparative study of the efficacy and safety of azithromycin compared with amoxicillin/clavulanic acid in the treatment of paediatric patients with otitis media.

Abstract

An open multicentre study was conducted in 484 children between the ages of 6 months and 12 years with otitis media to compare the efficacy, the safety and the tolerance of once-daily azithromycin given for three days versus thrice-daily amoxicillin/clavulanic acid (CA) given for ten days. A satisfactory response (cure plus improvement) was noted 10 to 14 days after the start of treatment in 199 of 215 (92.6%) azithromycin-treated children and in 186 of 198 (93.9%) amoxicillin/CA-treated children. The relationship between treatment and clinical response was independent of chronicity of infection and the presence or absence of a perforated eardrum. Improvement in signs and symptoms of otitis media occurred significantly more rapidly in the children treated with azithromycin. Treatment-related or possibly treatment-related adverse events were recorded in 11 of 243 (4.5%) azithromycin-treated patients and in 20 of 240 (8.3%) treated with amoxicillin/CA. No patients in the azithromycin treatment group were withdrawn from treatment, but six amoxicillin/CA patients, including two < 2 years of age, discontinued treatment prematurely because of adverse events; the difference between treatment groups was statistically significant (p = 0.0146). It is concluded that azithromycin given as an oral suspension once daily for three days is as safe and effective as amoxicillin/CA given thrice daily for ten days in the treatment of children with otitis media.

• Authors: N Principi
• Journal: European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology (Eur J Clin Microbiol Infect Dis) Vol. 14 Issue 8 Pg. 669-76 (Aug 1995) ISSN: 0934-9723 [Print] Germany
• PMID: 8565983 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Anti-Bacterial Agents
• Clavulanic Acids
• Amoxicillin-Potassium Clavulanate Combination
• Amoxicillin
• Azithromycin

Topics

• Amoxicillin (administration & dosage, therapeutic use)
• Amoxicillin-Potassium Clavulanate Combination
• Analysis of Variance
• Anti-Bacterial Agents (administration & dosage, therapeutic use)
• Azithromycin (administration & dosage, therapeutic use)
• Child
• Child, Preschool
• Clavulanic Acids (administration & dosage, therapeutic use)
• Drug Therapy, Combination (administration & dosage, therapeutic use)
• Female
• Humans
• Infant
• Male
• Otitis Media (drug therapy)
• Treatment Outcome