Randomised controlled trial of amoxycillin clavulanate in children with chronic
wet cough.
Author(s): Marchant J, Masters IB, Champion A, Petsky H, Chang AB.
Affiliation(s): Queensland Children's Respiratory Centre, Royal Children's Hospital, Herston,
Queensland 4029, Australia. j.marchant@uq.edu.au
Publication date & source: 2012, Thorax. , 67(8):689-93
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.
CONCLUSION: 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. CLINICAL TRIAL
NUMBER: ACTRN 12605000533695.
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