An intervention study to determine if a longer duration of antibiotics (compared to shorter duration) improves the short and long term clinical outcomes of children hospitalised for pneumonia

Indigenous Australian children have the world’s highest published rates of hospitalised pneumonia and chronic lung disease including bronchiectasis (BE). Children from developing countries are also at a similar risk. Yet, optimal treatment of pneumonia and how to prevent its long-term effects remain unclear. Trials have focused upon short-term (1-2 wk) outcomes and reduced antibiotic (AB) courses in children with non-severe (viral) pneumonia. However, in high-risk populations from Australia and Malaysia, a longer course of ABs may enhance bacteria clearance and thus reduce the risk of chronic lung disease after severe bacterial pneumonia in young children whose lungs are still developing. Our international multicentre, double-blind RCT is designed to answer our primary question: Does a longer course of ABs (13-14 days) compared to a short course (5-6 days) improve short and long-term outcomes of young children hospitalised with chest xray-proven pneumonia? We will randomise 314 children (aged 3 months to 5 yrs) from 4 sites. Children will be seen at clinically important time points (4 wk, 12 and 24 months) and blood, nasopharyngeal swabs and chest x-rays collected, based on pilot data. Data from this first such study worldwide will substantially advance child pneumonia treatment with implications for future lung health, especially in high-risk Indigenous children. Results would lead to changes in national and international guidelines. As a longer AB treatment for all children may increase AB resistance and lead to ‘over-treatment’ in some, we will address these 2 issues by monitoring for AB resistance and embark on a discovery program to identify biomarkers that predict poor long-term respiratory health outcomes. Availability of novel biomarkers from host gene expression will help clinicians decide which children are at high risk, and therefore in need of more intensive follow up, and may enable targeting of longer AB treatment to those at highest risk of BE.