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

Summary

Antibiotics are a mainstay of the treatment of lower respiratory infections in young children 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 resource-constrained settings are urgently required to safely improve antibiotic stewardship and stem the rising rates of antibiotic resistance globally.

In the Bangladesh Lung Auscultation Artificial Intelligence for Antibiotic Stewardship Trial (BLAAAST) the investigators aim to determine whether treatment failure frequency among children in rural Bangladesh managed by clinical guidelines enhanced by a commercially available, artificial intelligence (AI)-enabled digital stethoscope is non-inferior to guidelines alone. The investigators 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%. The investigators will also evaluate if a diagnostic strategy enhanced by an AI-enabled digital stethoscope is a sustainable alternative to standard care for children in rural Bangladesh. The investigators hypothesize that care augmented by an AI-enabled digital stethoscope will have additional benefits via reduced antibiotic use that will outweigh digital auscultation costs resulting in cost-effectiveness compared to current practice.

BLAAAST affords a unique opportunity to evaluate the efficacy of clinical guidelines enhanced by an AI-enabled 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.

Conditions

• Respiratory Infections in Children

Interventions

DEVICE

Automated digital stethoscope

The digital auscultation system intervention is comprised of a wireless electronic stethoscope and mobile phone application that records and analyzes lung sounds using an automated algorithm. The system has achieved European Union Class IIa medical device certification (EU Class IIa), which confirms its safety and clinical performance, and permits its use in clinical facilities by healthcare workers.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Projahnmo Research Foundation

  collaborator OTHER

• University College, London

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Eric McCollum, MD, MPH · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2029-06-30

Completion

2029-06-30

Countries

• Bangladesh

Study Locations