The BLAAAST Trial: Bangladesh Lung Auscultation AI for Antibiotic Stewardship Randomized Controlled Trial
Trial ID: NCT07362433
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: PHASE4
Start date: 2026-06-01
Completion date: 2029-06-30
Sponsor: Johns Hopkins University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Projahnmo Research Foundation; University College, London; Thomas Jefferson University; University of Washington
Conditions: Respiratory Infections in Children
Interventions: Automated digital stethoscope
Locations: Projahnnmo Research Foundation
Countries: Bangladesh
Enrollment: 2500
Age range: 2 Months - 59 Months
Sex: ALL

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.

Eligibility criteria:
Inclusion Criteria:

* 2 to 59 months of age (60 days to 59 months 29 days),
* illness duration 14 days or less,
* meeting non-severe pneumonia criteria, and
* from the trial catchment areas.

Exclusion Criteria:

* prior participation,
* age \<2 months or \>59 months,
* illness duration \>14 days,
* not meeting IMCI-defined non-severe pneumonia criteria,
* oxygen saturation (SpO2) \<90%,
* moderate or severe malnutrition,
* known chronic disease,
* history of prematurity,
* one or more high risk clinical signs (any WHO-defined clinical danger sign and/or WHO-defined emergency sign),
* known antibiotic exposure in the past 1 week,
* non-respiratory illness requiring systemic antibiotic treatment according to IMCI guidelines.

Outcomes:
Treatment failure