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NCT07362433: BLAAAST
Trial of an AI-enabled Digital Stethoscope to Improve Antibiotic Stewardship
Phase 4 trial testing Automated digital stethoscope in Respiratory Infections in Children in 2,500 participants. Not yet recruiting.
30 June 2029
Quick facts
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | Phase 4 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | diagnostic |
| Enrollment | 2,500 |
| Start date | 1 May 2026 |
| Primary completion | 30 June 2029 |
| Estimated completion | 30 June 2029 |
| Sites | 1 location across Bangladesh |
Drugs / interventions tested
- Automated digital stethoscope
Conditions studied
- Respiratory Infections in Children — all drugs for Respiratory Infections in Children →
Sponsor
Johns Hopkins University
Who can join
Adults 2 Months to 59 Months, any sex, with Respiratory Infections in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07362433 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
- Last refreshed: 23 January 2026
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