Randomised controlled trial of amoxycillin clavulanate in children with chronic wet cough
- 1Queensland Children's Respiratory Centre, Royal Children's Hospital, Brisbane, Australia
- 2Queensland Children's Medical Research Institute, University of Queensland, Brisbane, Australia
- 3Department of Pharmacy, Royal Children's Hospital, Brisbane, Australia
- 4Menzies School of Health Research, Child Health Division, Darwin, Northern Territory, Australia
- Correspondence to Dr Julie Marchant, Queensland Children's Respiratory Centre, Royal Children's Hospital, Herston, Queensland 4029, Australia;
Contributors JM and AC conceived the study, participated in statistical analyses and drafted the manuscript. All authors participated in design and coordination and read and approved the final manuscript.
- Received 14 December 2011
- Accepted 26 April 2012
- Published Online First 24 May 2012
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.
- antibacterial agents
- randomised controlled trial
- infections-respiratory tract
- paediatric lung disease
- cystic fibrosis
- paediatric asthma
- paediatric lung disease
- paediatric physician
- sleep apnoea
Funding JM was funded by the Royal Children's Hospital Foundation, Brisbane and TSANZ/Allen and Hanbury's Paediatric Respiratory Medicine Career Development Fellowship. ABC is funded by an Australian National Health and Medical Research Council Practitioner Fellowship (grant number 545216).
Competing interests None.
Ethics approval Ethics approval was provided by Royal Children's Hospital and University of Queensland Ethics Committees.
Provenance and peer review Not commissioned; externally peer reviewed.