ToolCAP: Novel Tools to Improve the Management of Paediatric Community-Acquired Pneumonia – a Preliminary Study Protocol for a Randomised Controlled Trial

Background Lower respiratory tract infections (LRTIs), particularly pneumonia, are a leading cause of morbidity and mortality among children worldwide, especially in low-resource settings. The World Health Organization (WHO) Integrated Management of Childhood Illness (IMCI) guidelines currently recommend antibiotic treatment for all case of with pneumonia based on clinical signs along, which can lead to over-prescription of antibiotics and contribute to antimicrobial resistance (AMR). Point of care Lung Ultrasound (LUS) has emerged as a promising diagnostic tool in this context and has demonstrated potential in distinguishing between bacterial and viral pneumonia, thus enabling more targeted antibiotic use. This study aims to explore whether integrating LUS into the IMCI-based management of clinical pneumonia will better identify those who would benefit from antibiotic treatment, reducing antibiotic overuse without compromising health outcomes. Methods An open label randomized controlled trial will enrol 3500 children aged 60 days to 12 years presenting with IMCI-defined pneumonia. Participants will be enrolled in Senegal, Tanzania, and South Africa. Participants will be randomly assigned in a ratio of 1:1, stratified by site and age group (<5years, 5-12years) to either an intervention group, where LUS will guide antibiotic prescriptions utilising a predefined interpretation framework, or a control group receiving routine IMCI-based care. The co-primary outcomes of this study are the reduction in antibiotic use on the day of enrolment (Day 1) and rate of clinical failure by Day 8, using an acceptable clinical difference of 1.5x as a non-inferiority margin (delta of 2.5%). Secondary outcomes will include adverse drug reactions, cure rates, hospital admissions including in-patient duration, and cost-effectiveness. Data will be collected at baseline (Day 1), Day 8, and Day 29 post-enrolment. Discussion This study seeks to provide evidence on the clinical and public health benefits of using LUS to improve the diagnosis and management of paediatric pneumonia in low-resource settings. If this intervention proves effective it could contribute significantly toward reducing unnecessary antibiotic prescriptions, thereby addressing AMR. The potential for LUS to be integrated into routine clinical practice could revolutionize pneumonia management, especially in areas with limited access to advanced diagnostic tools. Trial Registration This trial will be registered on ClinicalTrials.gov and The South African National Clinical Trials Register (SANCTR) prior to participant enrolment.