Bangladesh Lung Auscultation AI for Antibiotic Stewardship Randomized Controlled Trial (The BLAAST Trial)
Study period: January 2025 to December 2029
Donor name: National Institutes of Health (NIH), USA
Project Description: Johns Hopkins University School of Medicine, USA; Johns Hopkins Bloomberg School of Public Health, USA; University College London, UK; Thomas Jefferson University School of Medicine, USA; University of North Carolina-Chapel Hill School of Medicine, USA; University of Washington, USA
Project Description:
Background: Acute lower respiratory infections are a leading cause of death among children in low- and middle-income countries (LMICs) like Bangladesh. According to the Integrated Management of Childhood Illness (IMCI) guidelines, children with respiratory symptoms are assessed, and antibiotics are recommended if they are classified as having pneumonia. However, with high coverage of pneumococcal conjugate vaccine (PCV) and Haemophilus influenzae type B (Hib) vaccination, most cases classified as pneumonia may be due to viral infections, such as respiratory syncytial virus (RSV), and may not require antibiotics. Innovative child friendly tools like automated digital stethoscopes can improve the diagnosis of respiratory illnesses, safely reduce the unnecessary use of antibiotics, and are suitable for implementation in LMICs. These advancements are urgently required to improve antibiotic stewardship and address rising threat of antibiotic resistance globally.
Objective: Methods: Objective 1 is a randomized, double-blinded, placebo-controlled, non-inferiority trial. We are recruiting 2,500 children aged 2-59 months who are presenting with non-severe pneumonia (fast breathing and/or chest indrawing, with the absence of a WHO-defined danger sign) to the study hospitals of Zakiganj and Beanibazar in Sylhet District. We are recording lung sounds for all eligible children. Children in the control group are receiving amoxicillin syrup per IMCI pneumonia guidelines, while those in the intervention group are receiving amoxicillin syrup or placebo based on the automated algorithm’s lung sound classification. Community health workers are following up with the children at home on days 2, 3, 5, 7, and 14. The primary outcome is treatment failure within seven days, and the secondary outcome is treatment failure and relapse by day 14.
Objective 2 is a prospective observational study of participating health care workers (HCWs), conducted in parallel with the trial, where we are enrolling 60 HCWs, 24 caregivers, and 180 children.
For Objective 3, we are conducting an economic evaluation to estimate cost-effectiveness, considering the opportunity costs of a digital auscultation strategy expected to reduce antibiotic use in children.
Significance: This study 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.
1. Efficacy - Determine whether treatment failure frequency among children in rural Bangladesh managed by IMCI guidelines enhanced by a novel automated digital stethoscope (‘enhanced IMCI’) is non-inferior to IMCI guidelines alone.
2. Implementation - Assess digital auscultation implementation and antibiotic use during pediatric respiratory care in rural Bangladesh to inform strategies of antibiotic stewardship.
3. Cost effectiveness - Determine whether an ‘enhanced IMCI’ strategy of digital auscultation is a sustainable alternative to standard care for children in rural Bangladesh.