title: Randomised controlled trial of amoxycillin clavulanate in children with chronic wet cough.
abstract: BACKGROUND
  Despite guideline recommendations, there are no published randomised controlled trial data on the efficacy of antibiotics for chronic wet cough in children. The majority of children with chronic wet cough have protracted bacterial bronchitis (PBB), a recognised condition in multiple national guidelines. The authors conducted a parallel 1:1 placebo randomised controlled trial to test the hypothesis that a 2-week course of amoxycillin clavulanate is efficacious in the treatment of children with chronic wet cough.
  
  
  METHODS
  50 children (median age 1.9 years, IQR 0.9-5.1) with chronic (>3 weeks) wet cough were randomised to 2 weeks of twice daily oral amoxycillin clavulanate (22.5 mg/kg/dose) or placebo. The primary outcome was 'cough resolution' defined as a >75% reduction in the validated verbal category descriptive cough score within 14 days of treatment compared with baseline scores, or cessation of cough for >3 days. In selected children, flexible bronchoscopy and bronchoalveolar lavage (BAL) were undertaken at baseline.
  
  
  RESULTS
  Cough resolution rates (48%) were significantly higher in children who received amoxycillin clavulanate compared with those who received placebo (16%), p=0.016. The observed difference between proportions was 0.32 (95% CI 0.08 to 0.56). Post treatment, median verbal category descriptive score in the amoxycillin clavulanate group of 0.5 (IQR 0.0-2.0) was significantly lower than in the placebo group, 2.25 (IQR 1.15-2.9) (p=0.02). Pre-treatment BAL data were consistent with PBB in the majority of children, with no significant difference between groups.
  
  
  CONCLUSIONS
  A 2-week course of amoxycillin clavulanate will achieve cough resolution in a significant number of children with chronic wet cough. BAL data support the diagnosis of PBB in the majority of these children.
  
  
  BACKGROUND
  ACTRN 12605000533695.
authors.affiliation: Queensland Children's Respiratory Centre, Royal Children's Hospital, Herston, Queensland 4029, Australia. j.marchant@uq.edu.au
authors.forename: Julie
authors.initials: J
authors.lastname: Marchant
authors.forename: Ian Brent
authors.initials: IB
authors.lastname: Masters
authors.forename: Anita
authors.initials: A
authors.lastname: Champion
authors.forename: Helen
authors.initials: H
authors.lastname: Petsky
authors.forename: Anne B
authors.initials: AB
authors.lastname: Chang
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001991:Bronchitis / Q000150:complications / Q000188:drug therapy; D001992:Bronchoalveolar Lavage Fluid / Q000166:cytology; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D003371:Cough / Q000188:drug therapy* / Q000382:microbiology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D019980:Amoxicillin-Potassium Clavulanate Combination