Randomised controlled trial of amoxycillin clavulanate in children with chronic wet cough
Julie Marchant1, Ian Brent Masters, Anita Champion
1Queensland Children's Respiratory Centre, Royal Children's Hospital, Herston, Queensland 4029, Australia. j.marchant@uq.edu.au
Insights
A 2-week course of amoxicillin clavulanate effectively resolved chronic wet cough in children, with significantly higher resolution rates compared to placebo. This antibiotic treatment is recommended for children diagnosed with protracted bacterial bronchitis (PBB).
Area of Science:
- Pediatric Pulmonology
- Infectious Diseases
- Clinical Trials
Background:
- Chronic wet cough in children often indicates protracted bacterial bronchitis (PBB).
- Limited randomized controlled trial (RCT) data exist on antibiotic efficacy for pediatric chronic wet cough.
- This study addresses the need for evidence-based treatment guidelines.
Purpose of the Study:
- To evaluate the efficacy of a 2-week amoxicillin clavulanate course for chronic wet cough in children.
- To test the hypothesis that this antibiotic regimen improves cough resolution.
- To provide data supporting treatment guidelines for PBB.
Main Methods:
- A parallel 1:1 placebo-controlled randomized trial was conducted.
- 50 children with chronic (>3 weeks) wet cough received amoxicillin clavulanate or placebo for 2 weeks.
- Cough resolution was defined as >75% reduction in cough score or >3 days of no cough.
Main Results:
- Cough resolution occurred in 48% of children receiving amoxicillin clavulanate versus 16% receiving placebo (p=0.016).
- Amoxicillin clavulanate significantly reduced cough severity scores post-treatment.
- Bronchoalveolar lavage (BAL) data supported PBB diagnosis in most participants.
Conclusions:
- Amoxicillin clavulanate is effective in resolving chronic wet cough in a significant proportion of children.
- BAL findings confirm PBB as the likely underlying condition.
- The findings support the use of amoxicillin clavulanate for PBB.
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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