title: A pilot study of single-dose azithromycin versus three-day azithromycin or single-dose ceftriaxone for uncomplicated acute otitis media in children.
abstract: BACKGROUND
  The pharmacokinetic profile of azithromycin supports its use as single-dose therapy for uncomplicated acute otitis media (AOM) in children.
  
  
  OBJECTIVE
  This study was designed to (1) compare the safety of single-dose oral azithromycin, 3 daily doses of oral azithromycin, and a single dose of intramuscular ceftriaxone for the treatment of uncomplicated AOM in children, and (2) provide preliminary efficacy data to support initiation of a larger, comparative trial of single-dose azithromycin for the treatment of uncomplicated acute otitis media in children.
  
  
  METHODS
  In this single-center pilot study, children with uncomplicated AOM were randomly assigned to receive single-dose oral azithromycin (30 mg/kg), 3-day oral azithromycin (10 mg/kg once daily), or single-dose intramuscular ceftriaxone (50 mg/kg). Tympanocentesis was performed before administration of the first dose, and clinical response was assessed on days 14-15 and 28-30.
  
  
  RESULTS
  Between September 1995 and May 1997, 198 children (mean age, 2.5 years) were enrolled. All of the patients were evaluable for the safety and clinical intent-to-treat (ITT) analyses, and 98 were evaluable for the microbiologic ITT analysis. On day 14-15, rates of clinical success (cure or improvement) for the 3 treatment groups were: 62/64 (97%) for single-dose azithromycin, 60/63 (95%) for 3-day azithromycin, and 61/62 (98%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 61/65 (94%), 61/66 (92%), and 62/64 (97%). For the 98 microbiologically evaluable patients, clinical success rates at day 14-15 were 28/30 (93%) for single-dose azithromycin, 31/35 (89%) for 3-day azithromycin, and 33/33 (100%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 27/30 (90%), 30/35 (86%), and 32/33 (97%). Treatment-related adverse event rates for single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone were 10.6%, 9.1%, and 9.1%, respectively.
  
  
  CONCLUSIONS
  In this pilot study comparing single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone for the treatment of uncomplicated AOM in children, no differences were detected among the 3 regimens.
authors.affiliation: Instituto de Atención Pediátrica.
authors.forename: Adriano
authors.initials: A
authors.lastname: Arguedas
authors.affiliation: Instituto de Atención Pediátrica.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Loaiza
authors.affiliation: Instituto de Atención Pediátrica.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Perez
authors.affiliation: Laboratorio Centro de Investigaciones Clinicas;
authors.forename: Alvaro
authors.initials: A
authors.lastname: Gutierrez
authors.affiliation: Clinical Laboratory, Hospital Nacional de Niños, San José, Costa Rica, and.
authors.forename: Marco Luis
authors.initials: ML
authors.lastname: Herrera
authors.affiliation: Pfizer Inc, New York, New York, USA.
authors.forename: Constance D
authors.initials: CD
authors.lastname: Rothermel
keywords: Haemophilus influenzae; Streptococcus pneumoniae; acute otitis media; azithromycin; ceftriaxone; short-course therapy