24-month outcomes of extended vs standard-course antibiotic therapy in children hospitalised with pneumonia in high-risk settings: a multi-centre RCT

Background: Community-acquired pneumonia (CAP) is associated with bronchiectasis. We determined if an extended (13-14 days) vs standard (5-6 days) antibiotic course improves long-term outcomes in children hospitalised with CAP from high-risk settings.

Methods: We undertook a multi-centre RCT in Malaysian and Indigenous Australian and New Zealand children aged 3-months to ≤5-years hospitalised with CAP. They received 1-3 days of IV antibiotics, then 3-days of oral co-amoxiclav and were then randomised to extended (8-days oral co-amoxiclav) or standard-course (8-days oral placebo) arms. Children were reviewed at 12 and 24-months. The primary outcome was children with a composite endpoint of chronic respiratory symptoms/signs (chronic cough at 12 and 24-months; ≥1 subsequent hospitalised lower respiratory infection; or persistent/new chest x-ray signs at 12-months) at 24-months post-discharge. We used ITT analysis where children with incomplete follow-up were assumed to have chronic respiratory symptoms/signs.

Results: 324 children were randomised (extended [n=163], standard [n=161]). For our primary outcome, chronic respiratory symptoms/signs occurred in 97/163 (60%) and 94/161 (58%) children in the extended and standard-courses respectively (RR 1.02, 95%CI 0.85-1.22). Where all sub-composite outcomes were known, chronic respiratory symptoms/signs occurred in 27/93 (29%) and 24/91 (26%) children from the extended and standard-courses respectively (RR 1.10, 95%CI 0.69-1.76).

Conclusion: In children from high-risk populations hospitalised with CAP, 13-14 days of antibiotics (vs 5-6 days), did not improve long-term respiratory outcomes.