title: Single-dose extended-release azithromycin versus a 10-day regimen of amoxicillin/clavulanate for the treatment of children with acute otitis media.
abstract: OBJECTIVE
  A randomized, double-blind, double-dummy, multicenter international study was conducted to assess the clinical and bacteriologic response, safety, and compliance of a single 60-mg/kg dose of azithromycin extended-release (ER) versus a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in children with acute otitis media at high risk of persistent or recurrent middle ear infection.
  
  
  METHODS
  Children aged 3 to 48 months were enrolled and stratified into two age groups (≤ 24 months and >24 months). Pretreatment tympanocentesis was performed at all sites and was repeated during treatment at selected sites.
  
  
  RESULTS
  The primary endpoint, clinical response at the test-of-cure visit in the bacteriologic eligible population, was achieved in 80.5% of children in the azithromycin ER group and 84.5% of children in the amoxicillin/clavulanate group (difference-3.9%; 95% confidence interval-10.4, 2.6). Bacteriologic eradication was 82.6% in the azithromycin ER group and 92% in the amoxicillin/clavulanate group (p=0.050). Children who received amoxicillin/clavulanate had significantly higher rates of dermatitis and diarrhea, a greater burden of adverse events, and a lower rate of compliance to study drug compared to those who received azithromycin ER.
  
  
  CONCLUSIONS
  A single 60-mg/kg dose of azithromycin ER provides near equivalent effectiveness to a 10-day regimen of amoxicillin/clavulanate 90/6.4 mg/kg per day in the treatment of children with acute otitis media.
authors.affiliation: Instituto de Atención Pediátrica, PO Box 607-1150, La Uruca, San José, Costa Rica. aarguedas@iped.net
authors.forename: Adriano
authors.initials: A
authors.lastname: Arguedas
authors.forename: Carolina
authors.initials: C
authors.lastname: Soley
authors.forename: Barbara J
authors.initials: BJ
authors.lastname: Kamicker
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Jorgensen
mesh_terms: D000208:Acute Disease; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000009:adverse effects* / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D017963:Azithromycin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D002675:Child, Preschool; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D007223:Infant; D010033:Otitis Media / Q000188:drug therapy* / Q000382:microbiology; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination; D017963:Azithromycin