title: Failure to achieve early bacterial eradication increases clinical failure rate in acute otitis media in young children.
abstract: BACKGROUND
  The objective of this study was to determine the association between early bacteriologic failure and clinical failure in acute otitis media (AOM).
  
  
  METHODS
  Children with AOM aged 3-35 months enrolled in studies documenting both bacteriologic outcomes by tympanocentesis on day 4-6 and clinical outcomes on day 11-16 (immediate posttreatment visit) constituted our study group. Bacteriologic outcomes were studied for children with AOM caused by Streptococcus pneumoniae, nontypeable Haemophilus influenzae or both. The relative risk (RR) for clinical failure of children with bacteriologic failure compared with children with bacteriologic eradication was the main outcome measure.
  
  
  RESULTS
  Nine hundred seven episodes were analyzed. Clinical failure occurred in 7.3% of 660 patients with bacterial eradication versus 32.8% of 247 patients with bacteriologic failures. The overall RR (95% confidence interval) for clinical failure was 4.41 (95% CI: 3.19-6.11), with little variation between pathogens. After correction for age, gender, ethnic origin, previous otitis history, and previous antibiotic treatment, the rate was 6.52 (95% CI: 4.26-9.99). Across clinical studies with 8 antibiotic drug regimens for AOM, the rate of clinical failure correlated with bacteriologic failure (r = 0.8967; P = 0.003).
  
  
  CONCLUSIONS
  In young children with culture-positive AOM, failure to eradicate the pathogen from middle ear fluid within the first few days of treatment leads to a significant risk for clinical failure.
authors.affiliation: Pediatric Infectious Disease Unit, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. rdagan@bgu.ac.il
authors.forename: Ron
authors.initials: R
authors.lastname: Dagan
authors.forename: Shira
authors.initials: S
authors.lastname: Schneider
authors.forename: Noga
authors.initials: N
authors.lastname: Givon-Lavi
authors.forename: David
authors.initials: D
authors.lastname: Greenberg
authors.forename: Alberto
authors.initials: A
authors.lastname: Leiberman
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jacobs
authors.forename: Eugene
authors.initials: E
authors.lastname: Leibovitz
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002675:Child, Preschool; D005260:Female; D006192:Haemophilus Infections / Q000628:therapy*; D006193:Haemophilus influenzae / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000382:microbiology* / Q000628:therapy*; D019152:Paracentesis; D013290:Streptococcal Infections / Q000628:therapy*; D013296:Streptococcus pneumoniae / Q000302:isolation & purification; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents