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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 4
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Bangladesh
Projahnnmo Research Foundation
RECRUITING
Sylhet
Contact Information
Primary
Eric D McCollum, MD, MPH
emccoll3@jhmi.edu
410-955-2035
Backup
Salahuddin Ahmed, PhD
sahmed@prfbd.org
+880 255 035 439
Time Frame
Start Date: 2026-06-02
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 2500
Treatments
Experimental: IMCI guidelines enhanced by automated digital stethoscope
IMCI child pneumonia guideline care enhanced by a commercially available automated digital stethoscope.
No_intervention: IMCI guidelines without automated digital stethoscope enhancement
Standard IMCI child pneumonia care that is not enhanced by a commercially available automated digital stethoscope.
Related Therapeutic Areas
Sponsors
Collaborators: University of Washington, Projahnmo Research Foundation, Thomas Jefferson University, University College, London, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov