Study of AI-Enhanced Digital Stethoscope to Improve Antibiotic Use in Children With Respiratory Infections in Bangladesh

What this Trial Is About

Researchers are evaluating the use of an artificial intelligence AI-enabled digital stethoscope to improve antibiotic use in children aged 2 to 59 months with lower respiratory infections in rural Bangladesh. The study aims to determine if clinical guidelines enhanced by this digital stethoscope can safely reduce unnecessary antibiotic use while maintaining treatment effectiveness. The trial also assesses whether this approach is a cost-effective alternative to standard care, addressing the global problem of rising antibiotic resistance. Participants will be randomly assigned to one of two groups. One group will receive care guided by clinical guidelines enhanced by the AI-enabled digital stethoscope, which classifies lung sounds to decide if amoxicillin syrup or placebo should be given twice daily for five days. The other group will receive standard care with amoxicillin as per guidelines. Digital lung sound recordings are taken from four chest positions using a wireless stethoscope, and analysis is done by an automated algorithm. Masking is maintained by applying the stethoscope to all children and hiding the results. Children will be followed for two weeks with at least six study visits, including home visits by community health workers on days 2, 3, 5, and 14, and a clinic visit on day 7 to assess treatment success or failure. Caregivers can contact the study team anytime via a hotline. Safety is closely monitored, with referrals to hospital for treatment failure signs or low oxygen levels. The trial will track treatment failure, relapse, and safety outcomes, aiming to provide evidence on whether AI-enhanced diagnosis can safely reduce antibiotic use in children with pneumonia symptoms.

Trial of an AI-enabled Digital Stethoscope to Improve Antibiotic Stewardship