Duration of amoxicillin-clavulanate for protracted bacterial bronchitis in children: a randomized controlled trial

Introduction: The optimal duration of antibiotic treatment for children with protracted bacterial bronchitis (PBB), a common cause of chronic wet cough in children, is controversial. Effective management may reduce the risk of chronic suppurative disease (e.g. bronchiectasis). Objective: To determine whether 4-wks of amoxicillin-clavulanate is superior to 2-wks for improved clinical outcomes in children with suspected PBB. Methods: Multi-center, double-blind, placebo-controlled, RCT in Australian children aged 2-mo to 19-yrs with suspected PBB. Children were randomized to either 4-wks of amoxicillin-clavulanate or 2-wks of amoxicillin-clavulanate followed by 2-wks placebo. Follow-up was for 6-mo. Our primary outcome was cough resolution within 28-days. Recurrence of PBB, parent-proxy cough specific quality of life (PC-QoL) score at 28-days and time to first exacerbation were secondary outcomes. Results: 106 children were randomized, median age 2.0-yrs. There was no difference in cough resolution by 28-days between the groups (4-wks=61.5% vs 2-wks=71.4%) (RR 0.87, 95% CI0.59-1.29; p=0.50). Longer antibiotic treatment resulted in a non-significant increase in time to next wet cough exacerbation (150-wks vs 48-wks; p=0.094) and reduced PBB recurrence (74% vs 53%; p=0.074) in those whose cough resolved by day-28. PC-QoL improved by a median of 2.0 across both groups. Conclusion: A 4-wk course of amoxicillin-clavulanate in children with suspected PBB confers little advantage compared to a 2-wk course. A non-inferiority RCT is required to support our findings but until such data is available, children suspected of having PBB should be treated with the current standard 2-wks