The BLAAST Trial: Bangladesh Lung Auscultation AI for Antibiotic Stewardship Randomized Controlled Trial

PROJECT SUMMARY: This is a submission for a National Institutes of Health R01 award called The BLAAST Project, which aims to conduct a randomized, double-blinded, placebo, non-inferiority trial of pediatric care enhanced by a novel automated digital stethoscope, compared to standard care, in Bangladesh (Aim 1) with an integrated

implementation assessment (Aim 2) and economic evaluation (Aim 3) over three years among young, low-risk children with non-severe clinical pneumonia. Antibiotics are a mainstay of the treatment of acute lower respiratory infections in young children in low- and middle-income countries (LMICs) like Bangladesh even

though most episodes are caused by self-limiting viruses. Innovative child friendly tools that improve the diagnosis of respiratory illnesses, safely reduce the unnecessary use of antibiotics, and are suitable for implementation in LMICs are urgently required to safely improve antibiotic stewardship and stem the rising

rates of antibiotic resistance globally. In this project (Bangladesh Lung Auscultation Artificial Intelligence for Antibiotic Stewardship or BLAAST) we aim to utilize a novel FDA-approved digital stethoscope with automated lung sound analytics developed and validated over a period of ten years from evidence across seven LMICs. In Aim 1, we will determine whether

treatment failure frequency among children in rural Bangladesh managed by clinical guidelines enhanced by a novel automated digital stethoscope is non-inferior to guidelines alone. We hypothesize treatment failure frequency among `enhanced IMCI' participants will be no worse than standard care by a +/-2% margin, safely

reducing antibiotic use by 50-60%. In Aim 2 we will assess digital auscultation implementation and antibiotic use during pediatric respiratory care in rural Bangladesh to inform strategies of antibiotic stewardship. Lastly, in Aim 3 we will evaluate if a diagnostic strategy enhanced by an automated digital stethoscope is a sustainable

alternative to standard care for children in rural Bangladesh. We hypothesize that care augmented by a digital stethoscope will have additional benefits via reduced antibiotic use that will outweigh digital auscultation costs resulting in cost-effectiveness compared to current practice. BLAAST affords a unique opportunity to evaluate the efficacy of clinical guidelines enhanced by an automated

digital stethoscope on child pneumonia outcomes in Bangladesh, if digital auscultation may be instrumental in the wider antibiotic stewardship strategy, and whether a digital stethoscope diagnostic tool is cost-effective in the care of children with respiratory illnesses.