1. Randomised controlled trial of amoxycillin clavulanate in children with chronic wet cough.
- Author
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Julie Marchant, Ian Brent Masters, Anita Champion, Helen Petsky, and Anne B Chang
- Subjects
RANDOMIZED controlled trials ,AMPICILLIN ,BRONCHITIS in children ,COUGH ,ANTIBIOTICS ,DRUG efficacy ,CHRONIC diseases in children ,BRONCHOSCOPY ,THERAPEUTICS - Abstract
BackgroundDespite 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.Methods50 children (median age 1.9â years, IQR 0.9â5.1) with chronic (>3â weeks) wet cough were randomised to 2â weeks of twice daily oral amoxycillin clavulanate (22.5â mg/kg/dose) or placebo. The primary outcome was âcough resolutionâ defined as a >75% reduction in the validated verbal category descriptive cough score within 14â days of treatment compared with baseline scores, or cessation of cough for >3â days. In selected children, flexible bronchoscopy and bronchoalveolar lavage (BAL) were undertaken at baseline.ResultsCough 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 0.0â2.0) was significantly lower than in the placebo group, 2.25 (IQR 1.15â2.9) (p=0.02). Pre-treatment BAL data were consistent with PBB in the majority of children, with no significant difference between groups.ConclusionA 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.Clinical trial numberACTRN 12605000533695. [ABSTRACT FROM AUTHOR]
- Published
- 2012
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