title: Treatment of acute otitis media in children under 2 years of age.
abstract: BACKGROUND
  Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media.
  
  
  METHODS
  We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure.
  
  
  RESULTS
  Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P=0.14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P=0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P=0.02). The rate of clinical failure--defined as the persistence of signs of acute infection on otoscopic examination--was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae.
  
  
  CONCLUSIONS
  Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00377260.).
authors.affiliation: Department of Pediatrics, University of Pittsburgh School of Medicine, Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center, Pittsburgh, PA 15224, USA. hoberman@chp.edu
authors.forename: Alejandro
authors.initials: A
authors.lastname: Hoberman
authors.forename: Jack L
authors.initials: JL
authors.lastname: Paradise
authors.forename: Howard E
authors.initials: HE
authors.lastname: Rockette
authors.forename: Nader
authors.initials: N
authors.lastname: Shaikh
authors.forename: Ellen R
authors.initials: ER
authors.lastname: Wald
authors.forename: Diana H
authors.initials: DH
authors.lastname: Kearney
authors.forename: D Kathleen
authors.initials: DK
authors.lastname: Colborn
authors.forename: Marcia
authors.initials: M
authors.lastname: Kurs-Lasky
authors.forename: Sonika
authors.initials: S
authors.lastname: Bhatnagar
authors.forename: Mary Ann
authors.initials: MA
authors.lastname: Haralam
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Zoffel
authors.forename: Carly
authors.initials: C
authors.lastname: Jenkins
authors.forename: Marcia A
authors.initials: MA
authors.lastname: Pope
authors.forename: Tracy L
authors.initials: TL
authors.lastname: Balentine
authors.forename: Karen A
authors.initials: KA
authors.lastname: Barbadora
mesh_terms: D000208:Acute Disease; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009305:Nasopharynx / Q000382:microbiology; D010033:Otitis Media / Q000175:diagnosis / Q000188:drug therapy*; D038781:Otoscopy; D011379:Prognosis; D012008:Recurrence; D012044:Regression Analysis; D013296:Streptococcus pneumoniae / Q000302:isolation & purification; D017211:Treatment Failure
chemical_list: D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination