Large dosade amoxicillin/clavulanate, compared with azithromycin, for the treatment of bacterial acute otitis media in children

A. Hoberman, R. Dagan, E. Leibovitz, A. Rosenblut, C. E. Johnson, A. Huff, R. Bandekar, B. Wynne

Research output: Contribution to journalArticlepeer-review


Background: A large dosage pediatric formulation of amoxicillin/clavulanate with an improved pharmacokinetic/pharmacodynamic profile was developed to eradicate many penicillin-resistant strains of Streptococcus pneumoniae and Haemophilus influenzae (including - lactamase-producing strains). Methods: This randomized, investigator-blinded, multicenter trial examined treatment of bacterial acute otitis media (AOM) in children 6-30 months of age with amoxicillin/clavulanate (90/6.4 mg/kg/d in 2 divided doses for 10 days) versus azithromycin (10 mg/kg for 1 day followed by 5 mg/kg/d for 4 days). Tympanocentesis was performed at entry for bacteriologie assessment, at the on-therapy visit (day 4-6) to determine bacterial eradication and at any time before the end-of-therapy visit (day 12-14) if the child was categorized as experiencing clinical failure. Clinical assessments were performed at the on-therapy, end-of-therapy and follow-up (day 21-25) visits. Results: We enrolled 730 children; AOM pathogens were isolated at baseline for 249 of the amoxicillin/clavulanate group and 245 of the azithromycin group. For children with AOM pathogens at baseline, clinical success rates at the end-of-therapy visit were 90.5% for amoxicillin/clavulanate versus 80.9% for azithromycin (P - 0.01), and those at the on-therapy and follow-up visits were 94.9% versus 88.0% and 80.3% versus 71.1%, respectively (all P - 0.05). At the on-therapy visit, pretherapy pathogens were eradicated for 94.2% of children receiving amoxicillin/clavulanate versus 70.3% of those receiving azithromycin (P - 0.001). Amoxicillin/clavulanateeradicated 96.0% of S. pneumonias (92.0% of fully penicillin-resistant S. pneumoniae) and 89.7% of H. influenzae (85.7% - 6 of 7 cases of -lactamase-positive H. influenzae). Corresponding rates for azithromycin were 80.4% (54.5%) for S. pneumoniae and 49.1% (100% - 1 of 1 case) for H. influenzae (all P - 0.01 for betweendrug comparisons). Conclusion: Amoxicillin/clavulanate was clinically and bacteriologically more effective than azithromycin among children with bacterial AOM, including cases caused by penicillin-resistant S. pneumoniae and - lactamase-positive H. influenzae.

Original languageEnglish
Pages (from-to)55-61
Number of pages7
Issue number4
StatePublished - 1 Dec 2006


  • Azithromycin
  • Bacterial acute otitis media
  • Clinical trial Pediatr Infect Dis J 2005;24: (525-532)
  • Extra-strength amoxicillin/clavulanate

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health


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