NCT07362433

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for phase_4

Timeline
38mo left

Started Jun 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

January 21, 2026

Last Update Submit

April 17, 2026

Conditions

Respiratory Infections in Children

Keywords

Digital auscultationAutomated digital stethoscopeArtificial intelligence lung sound analysisPediatric pneumoniaIntegrated Management of Childhood Illness (IMCI)Antibiotic stewardshipPoint-of-care respiratory diagnostics

Outcome Measures

Primary Outcomes (1)

  • Treatment failure

    Treatment failure (primary outcome) is defined as (1) death at any time on or before day 7, or (2) clinical deterioration (development of any WHO danger sign and/or any WHO emergency sign (i.e., 'high-risk' signs)) at any time on or before day 7, or (3) the presence of chest indrawing and/or very fast breathing for age on day 7 (not before day 7), or (4) lost-to-follow-up at any time on or before day 7, or (5) hospitalization for any reason at any time on or before day 7, or (6) a change in antibiotic treatment at any time on or before day 7. Clinical deterioration is defined as the development of (1) any WHO-defined clinical danger sign, and/or (2) WHO-defined emergency sign, and/or (3) hypoxemia (SpO2 \<90%) at any time after enrollment.

    7 days

Secondary Outcomes (19)

  • Treatment failure (modified)

    7 days

  • Treatment relapse

    14 days

  • Subgroup analysis: Treatment failure stratified by age

    7 days

  • Subgroup analysis: Treatment failure stratified by sex

    7 days

  • Subgroup analysis: Treatment failure stratified by study site

    7 days

  • +14 more secondary outcomes

Study Arms (2)

IMCI guidelines enhanced by automated digital stethoscope

EXPERIMENTAL

IMCI child pneumonia guideline care enhanced by a commercially available automated digital stethoscope.

Device: Automated digital stethoscope

IMCI guidelines without automated digital stethoscope enhancement

NO INTERVENTION

Standard IMCI child pneumonia care that is not enhanced by a commercially available automated digital stethoscope.

Interventions

Automated digital stethoscopeDEVICE

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.

IMCI guidelines enhanced by automated digital stethoscope

Eligibility Criteria

Age2 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Projahnnmo Research Foundation

Sylhet, Bangladesh

Location

Related Publications (12)

  • WHO. Integrated Management of Childhood Illness: Chart Booklet. 2014;https://apps.who.int/iris/bitstream/handle/10665/104772/9789241506823_Chartbook_eng.pdf.

    BACKGROUND

  • Ginsburg AS, Mvalo T, Nkwopara E, McCollum ED, Ndamala CB, Schmicker R, Phiri A, Lufesi N, Izadnegahdar R, May S. Placebo vs Amoxicillin for Nonsevere Fast-Breathing Pneumonia in Malawian Children Aged 2 to 59 Months: A Double-blind, Randomized Clinical Noninferiority Trial. JAMA Pediatr. 2019 Jan 1;173(1):21-28. doi: 10.1001/jamapediatrics.2018.3407.

    PMID: 30419120BACKGROUND

  • Jehan F, Nisar I, Kerai S, Balouch B, Brown N, Rahman N, Rizvi A, Shafiq Y, Zaidi AKM. Randomized Trial of Amoxicillin for Pneumonia in Pakistan. N Engl J Med. 2020 Jul 2;383(1):24-34. doi: 10.1056/NEJMoa1911998.

    PMID: 32609980BACKGROUND

  • McCollum ED, Park DE, Watson NL, Buck WC, Bunthi C, Devendra A, Ebruke BE, Elhilali M, Emmanouilidou D, Garcia-Prats AJ, Githinji L, Hossain L, Madhi SA, Moore DP, Mulindwa J, Olson D, Awori JO, Vandepitte WP, Verwey C, West JE, Knoll MD, O'Brien KL, Feikin DR, Hammitt LL. Listening panel agreement and characteristics of lung sounds digitally recorded from children aged 1-59 months enrolled in the Pneumonia Etiology Research for Child Health (PERCH) case-control study. BMJ Open Respir Res. 2017 Jun 30;4(1):e000193. doi: 10.1136/bmjresp-2017-000193. eCollection 2017.

    PMID: 28883927BACKGROUND

  • Emmanouilidou D, McCollum ED, Park DE, Elhilali M. Computerized Lung Sound Screening for Pediatric Auscultation in Noisy Field Environments. IEEE Trans Biomed Eng. 2018 Jul;65(7):1564-1574. doi: 10.1109/TBME.2017.2717280. Epub 2017 Jun 19.

    PMID: 28641244BACKGROUND

  • Hoekstra NE, Chagomerana MB, Smith ZH, Kala A, McLane I, Verwey C, Olson D, Buck WC, Mulindwa J, Gaudio A, Kapoor S, Schuh HB, Chiume M, Fitzgerald E, Elhilali M, Mvalo T, Hosseinipour M, McCollum ED. Performance of an artificial intelligence algorithm for interpreting lung sounds from children hospitalised with pneumonia in Malawi. J Glob Health. 2025 Sep 19;15:04264. doi: 10.7189/jogh.15.04264.

    PMID: 40968644BACKGROUND

  • Kala A, Husain A, McCollum ED, Elhilali M. An objective measure of signal quality for pediatric lung auscultations. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:772-775. doi: 10.1109/EMBC44109.2020.9176539.

    PMID: 33018100BACKGROUND

  • Graceffo S, Husain A, Ahmed S, McCollum ED, Elhilali M. Validation of Auscultation Technologies using Objective and Clinical Comparisons. Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:992-997. doi: 10.1109/EMBC44109.2020.9176456.

    PMID: 33018152BACKGROUND

  • Emmanouilidou D, McCollum ED, Park DE, Elhilali M. Adaptive Noise Suppression of Pediatric Lung Auscultations With Real Applications to Noisy Clinical Settings in Developing Countries. IEEE Trans Biomed Eng. 2015 Sep;62(9):2279-88. doi: 10.1109/TBME.2015.2422698. Epub 2015 Apr 13.

    PMID: 25879837BACKGROUND

  • Park DE, Watson NL, Focht C, Feikin D, Hammitt LL, Brooks WA, Howie SRC, Kotloff KL, Levine OS, Madhi SA, Murdoch DR, O'Brien KL, Scott JAG, Thea DM, Amorninthapichet T, Awori J, Bunthi C, Ebruke B, Elhilali M, Higdon M, Hossain L, Jahan Y, Moore DP, Mulindwa J, Mwananyanda L, Naorat S, Prosperi C, Thamthitiwat S, Verwey C, Jablonski KA, Power MC, Young HA, Deloria Knoll M, McCollum ED. Digitally recorded and remotely classified lung auscultation compared with conventional stethoscope classifications among children aged 1-59 months enrolled in the Pneumonia Etiology Research for Child Health (PERCH) case-control study. BMJ Open Respir Res. 2022 May;9(1):e001144. doi: 10.1136/bmjresp-2021-001144.

    PMID: 35577452BACKGROUND

  • Ahmed S, Sultana S, Khan AM, Islam MS, Habib GM, McLane IM, McCollum ED, Baqui AH, Cunningham S, Nair H. Digital auscultation as a diagnostic aid to detect childhood pneumonia: A systematic review. J Glob Health. 2022 Apr 23;12:04033. doi: 10.7189/jogh.12.04033. eCollection 2022.

    PMID: 35493777BACKGROUND

  • Grzywalski T, Piecuch M, Szajek M, Breborowicz A, Hafke-Dys H, Kocinski J, Pastusiak A, Belluzzo R. Practical implementation of artificial intelligence algorithms in pulmonary auscultation examination. Eur J Pediatr. 2019 Jun;178(6):883-890. doi: 10.1007/s00431-019-03363-2. Epub 2019 Mar 29.

    PMID: 30927097BACKGROUND

Study Officials

  • Eric McCollum, MD, MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric D McCollum, MD, MPH

CONTACT

410-955-2035emccoll3@jhmi.edu

Salahuddin Ahmed, PhD

CONTACT

+880 255 035 439sahmed@prfbd.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 23, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

The study will generate multiple gigabytes of de-identified individual-level data, shared as non-proprietary formats (.csv for tabular data; .wav for audio). Outcomes include treatment failure at Days 7 and 14, time to treatment failure, relapse by Day 14, modified treatment failure, outcomes stratified by age, sex, and clinic, and correct lower respiratory infection diagnosis. No participant identifiers will be shared. Metadata will include participant identification (ID) and a data dictionary. Associated documentation will include data collection instruments, methods, and final protocols. Data will be provided in formats accessible without specialized software. Common data elements, best practices, and standardized reporting approaches will be used where feasible. De-identified data, statistical analysis plans, and analytic code will be shared without restriction via public download.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Publicly shared data will be deposited into the open-source research data repository The Dataverse Project.
Access Criteria
Data will be shared by unrestricted download from The Dataverse Project open source research data repository.
More information

Locations

BA(1)