Respiratory Infections in ChildrenPhase 4BLAAASTNCT07362433
Trial of an AI-enabled Digital Stethoscope to Improve Antibiotic Stewardship
A Phase 4 study testing Automated digital stethoscope in people with Respiratory Infections in Children, run by Johns Hopkins University at 1 site in Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 59 months
- Conditions the study is for
- Respiratory Infections in Children
- What is being tested?
- Automated digital stethoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteBangladesh
- Study dates
- 2 Jun 2026to 30 Jun 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Projahnnmo Research Foundation
Sylhet
Salahuddin Ahmed, PhD, +880 255 035 439, sahmed@prfbd.org
About this study
Official title: The BLAAAST Trial: Bangladesh Lung Auscultation AI for Antibiotic Stewardship Randomized Controlled Trial
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.
Read the detailed description
Participants will be screened for eligibility by study physicians. Children who screen positive will then be assessed for eligibility. Written informed consent will be obtained. All enrolled children will have a lung sound recording obtained. Study physicians will sequentially record lung sounds using the digital stethoscope from four chest positions (two anterior and two posterior) on participants. Each chest position recording is 15 seconds, and the overall procedure ~2 minutes. Lung sound recordings will be transferred to an encrypted tablet and analyzed by the convolutional neural network model to automatically detect normal and abnormal lung sounds. Blocked randomization will occur after the recording has been completed. Children who consent and meet eligibility criteria will be randomized into one of two arms.
Children randomized to the intervention will receive amoxicillin syrup (250mg/5ml concentration) or placebo based on the automated algorithm's lung sound classification. Children receiving a positive digital stethoscope result will receive amoxicillin while children receiving a negative digital stethoscope results will receive placebo. All children in the control arm (standard care) will receive amoxicillin. Treatment duration will be five days per Integrate Management of Childhood Illnesses (IMCI) guidelines, administering the study product twice daily. Children randomized to the control group will receive amoxicillin syrup (250mg/5ml concentration) for five days as all controls will meet IMCI pneumonia criteria. Study physicians and caregivers in the IMCI clinic will be masked to the randomization group. Masking will be achieved by applying the digital stethoscope to all enrolled children and concealing the automated algorithm result on the device.
Trained community healthcare worker paramedics equipped a pulse oximeter and paracetamol will conduct home visits for all participants on study days 2, 3, 5, and 14 after enrollment (defined as Day 1). A study physician will conduct the day 7 study visit and assign the primary outcome. A 24-hour window period will be permitted for each home visit in the event that the participant is not available on the scheduled visit day.
Any child that meets treatment failure criteria will be immediately transported to the study facility (Upazila Health Complex) for study physician confirmation and further treatment planning. Similarly, an oxygen saturation measured as 90-94% will prompt referral to the study physician for assessment for treatment failure. Study physician confirmation is required for a treatment failure outcome. Caregivers will be provided a trial telephone hotline for communications between scheduled visits (by text message or phone call), should parental concerns arise between household visits. If caregivers prefer, the caregiver may also return to the study clinic for a study physician reassessment between community health worker (CHW) household visits.
For any participant receiving amoxicillin or placebo who is confirmed to have a World Health Organization (WHO)-defined emergency sign, WHO-defined clinical danger sign, or WHO-defined hypoxemia, and the child will be hospitalized and receive parenteral antibiotics according to WHO-guidelines and aligned with Bangladesh national guidelines. Further treatment and clinical management will be at the discretion of the treating physician. For any participant on amoxicillin or placebo who is confirmed to have lower chest wall indrawing and/or very fast breathing for age on day 7 and who is confirmed to be without any WHO-defined emergency signs, to be without any WHO-defined clinical danger signs, and to be without WHO-defined hypoxemia, then the child will be initiated on oral amoxicillin-clavulanic acid over a minimum of 5 days. Further treatment and clinical management will be at the discretion of the treating physician. Unblinding will occur only when knowledge of treatment allocation is essential for the clinical management of a participant or when required to address a serious adverse event or unexpected problem posing risk to participant safety.
Participants will be enrolled into the trial for a period of 2 weeks each. There is a minimum of 6 study visits. The use of a placebo in this study is justified to maintain participant adherence to the assigned treatment and ensure comparability between the intervention and control groups. Without a placebo, participants who do not receive antibiotics are likely to be dissatisfied and seek treatment from another provider, thereby introducing a protocol violation, observer bias, and compromising the study's validity by leading to an over- or underestimation of the true treatment effect. By ensuring blinding, the placebo is also crucial for reducing bias in outcome assessment by study investigators. In sum, by using a placebo, the study can accurately differentiate between the effects of appropriately withholding antibiotics and any potential treatment effects, thereby providing robust and reliable results that are most likely to impact on health policy.
With a sample size of 2500 and one-week (7 day) treatment failure rate in the placebo arm of the trial to be approximately 4% based on prior data, and the margin of non-inferiority was chosen to be 2% based on the largest clinically acceptable difference between treatment failure of the intervention compared to the standard care. Given these parameters, the investigators will have at least 80% power to reject the null hypothesis of inferiority given that the treatment failure rate in the intervention arm is equal to the placebo arm, at 4%, assuming a one-sided type one error of 0.05.
Requiring medical care, requiring hospitalization, and mortality among study participants will be recorded by the study as the 3 primary markers of safety. In addition to these 3 parameters, the investigators will collect data on all unexpected adverse events (AEs) that occur during the study period. AEs will be actively collected from enrollment through Day 14 post-enrollment, or until completion of all follow-up procedures, whichever occurs later.
Rigorous safety measures will be in place including eligibility restrictions to 'low risk' children with non-severe clinical pneumonia, a hotline for 24/7 communication, close household follow-up (at least 5 household visits, including daily over the first 3 days of illness), and facilitating participant clinic transportation if needed. The trial will have a Data Safety and Monitoring Board (DSMB) and Technical Advisory Group. If unscheduled healthcare facility visits are necessary, then participants will be reimbursed for any travel expenses incurred. Participants will not be directly compensated for study visits conducted in the home and for study visits coordinated with routine healthcare visits at hospitals.
- Conditions
- Respiratory Infections in Children
- Being tested
- Automated digital stethoscope
- Keywords
- Digital auscultation, Automated digital stethoscope, Artificial intelligence lung sound analysis, Pediatric pneumonia, Integrated Management of Childhood Illness (IMCI), Antibiotic stewardship, Point-of-care respiratory diagnostics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| IMCI guidelines enhanced by automated digital stethoscope | Experimental | IMCI child pneumonia guideline care enhanced by a commercially available automated digital stethoscope. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (19)
Treatment failure (modified)
Treatment failure (modified - secondary 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 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.
Measured: 7 days
Treatment relapse
Treatment relapse (secondary outcome) is defined as (1) death at any time after 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 after day 7, or (3) the presence of chest indrawing and/or very fast breathing for age after day 7, or (4) hospitalization for any reason at any time after 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 day 7.
Measured: 14 days
Subgroup analysis: Treatment failure stratified by age
Analysis of treatment failure (primary outcome definition) stratified by age
Measured: 7 days
Subgroup analysis: Treatment failure stratified by sex
Analysis of treatment failure (primary outcome definition) stratified by sex
Measured: 7 days
Subgroup analysis: Treatment failure stratified by study site
Analysis of treatment failure (primary outcome definition) stratified by study site
Measured: 7 days
Digital stethoscope classification agreement
Among a subgroup of participants, the agreement between the digital stethoscope automated analysis classification and an expert review panel classification of lung sounds collected at enrollment.
Measured: 1 day
Time to treatment failure in days
All treatment failure times in days, comparing the time until treatment failure between arms
Measured: 7 days
Subgroup analysis: Treatment failure (modified definition) stratified by age
Analysis of treatment failure (modified definition) stratified by age
Measured: 7 days
Subgroup analysis: Treatment relapse stratified by age
Analysis of treatment relapse stratified by age
Measured: 14 days
Subgroup analysis: Treatment failure (modified definition) stratified by sex
Analysis of treatment failure (modified definition) stratified by sex
Measured: 7 days
Subgroup analysis: Treatment relapse stratified by sex
Analysis of treatment relapse stratified by sex
Measured: 14 days
Subgroup analysis: Treatment failure (modified definition) stratified by study site
Analysis of treatment failure (modified definition) stratified by study site
Measured: 7 days
Subgroup analysis: Treatment relapse stratified by study site
Analysis of treatment relapse stratified by study site
Measured: 14 days
Digital stethoscope sensitivity
Among a subgroup of participants, the sensitivity of the digital stethoscope diagnosis relative to a gold standard diagnosis assigned by expert review.
Measured: 14 days
Digital stethoscope specificity
Among a subgroup of participants, the specificity of the digital stethoscope diagnosis relative to a gold standard diagnosis assigned by expert review.
Measured: 14 days
Digital stethoscope positive predictive value
Among a subgroup of participants, the positive predictive value of the digital stethoscope diagnosis relative to a gold standard diagnosis assigned by expert review.
Measured: 14 days
Digital stethoscope negative predictive value
Among a subgroup of participants, the negative predictive value of the digital stethoscope diagnosis relative to a gold standard diagnosis assigned by expert review.
Measured: 14 days
Digital stethoscope Likelihood Ratio
Among a subgroup of participants, the likelihood ratio of the digital stethoscope diagnosis relative to a gold standard diagnosis assigned by expert review.
Measured: 14 days
Digital Stethoscope diagnostic odds ratio
Among a subgroup of participants, the diagnostic odds ratio of the digital stethoscope diagnosis relative to a gold standard diagnosis assigned by expert review.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start2 Jun 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Respiratory Infections in ChildrenStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Eric McCollum, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362433
- Sponsor's protocol ID
- IRB00451423
- Other IDs
- R01HD115597
- Acronym
- BLAAAST
- Status last verified
- Jun 2026
- First submitted
- 21 Jan 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
WHO. Integrated Management of Childhood Illness: Chart Booklet. 2014;https://apps.who.int/iris/bitstream/handle/10665/104772/9789241506823_Chartbook_eng.pdf.
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.
PubMed 30419120Jehan 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.
PubMed 32609980McCollum 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.
PubMed 28883927Emmanouilidou 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.
PubMed 28641244Hoekstra 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.
PubMed 40968644Kala 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.
PubMed 33018100Graceffo 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.
PubMed 33018152Emmanouilidou 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.
PubMed 25879837Park 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.
PubMed 35577452Ahmed 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.
PubMed 35493777Grzywalski 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.
PubMed 30927097
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BLAAAST Trial: Bangladesh Lung Auscultation AI for Antibiotic Stewardship Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07362433
- Acronym / sponsor ID
- BLAAAST / IRB00451423
- Conditions
- Respiratory Infections in Children
- Keywords
- Digital auscultation, Automated digital stethoscope, Artificial intelligence lung sound analysis, Pediatric pneumonia, Integrated Management of Childhood Illness (IMCI), Antibiotic stewardship, Point-of-care respiratory diagnostics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- 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
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be screened for eligibility by study physicians. Children who screen positive will then be assessed for eligibility. Written informed consent will be obtained. All enrolled children will have a lung sound recording obtained. Study physicians will sequentially record lung sounds using the digital stethoscope from four chest positions (two anterior and two posterior) on participants. Each chest position recording is 15 seconds, and the overall procedure ~2 minutes. Lung sound recordings will be transferred to an encrypted tablet and analyzed by the convolutional neural network model to automatically detect normal and abnormal lung sounds. Blocked randomization will occur after the recording has been completed. Children who consent and meet eligibility criteria will be randomized into one of two arms.
Children randomized to the intervention will receive amoxicillin syrup (250mg/5ml concentration) or placebo based on the automated algorithm's lung sound classification. Children receiving a positive digital stethoscope result will receive amoxicillin while children receiving a negative digital stethoscope results will receive placebo. All children in the control arm (standard care) will receive amoxicillin. Treatment duration will be five days per Integrate Management of Childhood Illnesses (IMCI) guidelines, administering the study product twice daily. Children randomized to the control group will receive amoxicillin syrup (250mg/5ml concentration) for five days as all controls will meet IMCI pneumonia criteria. Study physicians and caregivers in the IMCI clinic will be masked to the randomization group. Masking will be achieved by applying the digital stethoscope to all enrolled children and concealing the automated algorithm result on the device.
Trained community healthcare worker paramedics equipped a pulse oximeter and paracetamol will conduct home visits for all participants on study days 2, 3, 5, and 14 after enrollment (defined as Day 1). A study physician will conduct the day 7 study visit and assign the primary outcome. A 24-hour window period will be permitted for each home visit in the event that the participant is not available on the scheduled visit day.
Any child that meets treatment failure criteria will be immediately transported to the study facility (Upazila Health Complex) for study physician confirmation and further treatment planning. Similarly, an oxygen saturation measured as 90-94% will prompt referral to the study physician for assessment for treatment failure. Study physician confirmation is required for a treatment failure outcome. Caregivers will be provided a trial telephone hotline for communications between scheduled visits (by text message or phone call), should parental concerns arise between household visits. If caregivers prefer, the caregiver may also return to the study clinic for a study physician reassessment between community health worker (CHW) household visits.
For any participant receiving amoxicillin or placebo who is confirmed to have a World Health Organization (WHO)-defined emergency sign, WHO-defined clinical danger sign, or WHO-defined hypoxemia, and the child will be hospitalized and receive parenteral antibiotics according to WHO-guidelines and aligned with Bangladesh national guidelines. Further treatment and clinical management will be at the discretion of the treating physician. For any participant on amoxicillin or placebo who is confirmed to have lower chest wall indrawing and/or very fast breathing for age on day 7 and who is confirmed to be without any WHO-defined emergency signs, to be without any WHO-defined clinical danger signs, and to be without WHO-defined hypoxemia, then the child will be initiated on oral amoxicillin-clavulanic acid over a minimum of 5 days. Further treatment and clinical management will be at the discretion of the treating physician. Unblinding will occur only when knowledge of treatment allocation is essential for the clinical management of a participant or when required to address a serious adverse event or unexpected problem posing risk to participant safety.
Participants will be enrolled into the trial for a period of 2 weeks each. There is a minimum of 6 study visits. The use of a placebo in this study is justified to maintain participant adherence to the assigned treatment and ensure comparability between the intervention and control groups. Without a placebo, participants who do not receive antibiotics are likely to be dissatisfied and seek treatment from another provider, thereby introducing a protocol violation, observer bias, and compromising the study's validity by leading to an over- or underestimation of the true treatment effect. By ensuring blinding, the placebo is also crucial for reducing bias in outcome assessment by study investigators. In sum, by using a placebo, the study can accurately differentiate between the effects of appropriately withholding antibiotics and any potential treatment effects, thereby providing robust and reliable results that are most likely to impact on health policy.
With a sample size of 2500 and one-week (7 day) treatment failure rate in the placebo arm of the trial to be approximately 4% based on prior data, and the margin of non-inferiority was chosen to be 2% based on the largest clinically acceptable difference between treatment failure of the intervention compared to the standard care. Given these parameters, the investigators will have at least 80% power to reject the null hypothesis of inferiority given that the treatment failure rate in the intervention arm is equal to the placebo arm, at 4%, assuming a one-sided type one error of 0.05.
Requiring medical care, requiring hospitalization, and mortality among study participants will be recorded by the study as the 3 primary markers of safety. In addition to these 3 parameters, the investigators will collect data on all unexpected adverse events (AEs) that occur during the study period. AEs will be actively collected from enrollment through Day 14 post-enrollment, or until completion of all follow-up procedures, whichever occurs later.
Rigorous safety measures will be in place including eligibility restrictions to 'low risk' children with non-severe clinical pneumonia, a hotline for 24/7 communication, close household follow-up (at least 5 household visits, including daily over the first 3 days of illness), and facilitating participant clinic transportation if needed. The trial will have a Data Safety and Monitoring Board (DSMB) and Technical Advisory Group. If unscheduled healthcare facility visits are necessary, then participants will be reimbursed for any travel expenses incurred. Participants will not be directly compensated for study visits conducted in the home and for study visits coordinated with routine healthcare visits at hospitals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMCI guidelines enhanced by automated digital stethoscope | Experimental | Device: Automated digital stethoscopeIMCI child pneumonia guideline care enhanced by a commercially available 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. |
Who may qualify
- Ages
- 2 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- prior participation,
- age <2 months or >59 months,
- illness duration >14 days,
- not meeting IMCI-defined non-severe pneumonia criteria,
- oxygen saturation (SpO2) <90%,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated digital stethoscopeThe 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. | Device | IMCI guidelines enhanced by automated digital stethoscope |
Primary outcome
Treatment failure
Time frame: 7 days
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.
19 secondary outcomes
Treatment failure (modified)
Time frame: 7 days
Treatment relapse
Time frame: 14 days
Subgroup analysis: Treatment failure stratified by age
Time frame: 7 days
Subgroup analysis: Treatment failure stratified by sex
Time frame: 7 days
Subgroup analysis: Treatment failure stratified by study site
Time frame: 7 days
Digital stethoscope classification agreement
Time frame: 1 day
Time to treatment failure in days
Time frame: 7 days
Subgroup analysis: Treatment failure (modified definition) stratified by age
Time frame: 7 days
Subgroup analysis: Treatment relapse stratified by age
Time frame: 14 days
Subgroup analysis: Treatment failure (modified definition) stratified by sex
Time frame: 7 days
Subgroup analysis: Treatment relapse stratified by sex
Time frame: 14 days
Subgroup analysis: Treatment failure (modified definition) stratified by study site
Time frame: 7 days
Subgroup analysis: Treatment relapse stratified by study site
Time frame: 14 days
Digital stethoscope sensitivity
Time frame: 14 days
Digital stethoscope specificity
Time frame: 14 days
Digital stethoscope positive predictive value
Time frame: 14 days
Digital stethoscope negative predictive value
Time frame: 14 days
Digital stethoscope Likelihood Ratio
Time frame: 14 days
Digital Stethoscope diagnostic odds ratio
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- BackgroundWHO. Integrated Management of Childhood Illness: Chart Booklet. 2014;https://apps.who.int/iris/bitstream/handle/10665/104772/9789241506823_Chartbook_eng.pdf.
- Background: PubMed 30419120Ginsburg 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.
- Background: PubMed 32609980Jehan 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.
- Background: PubMed 28883927McCollum 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.
- Background: PubMed 28641244Emmanouilidou 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.
- Background: PubMed 40968644Hoekstra 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.
- Background: PubMed 33018100Kala 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.
- Background: PubMed 33018152Graceffo 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.
- Background: PubMed 25879837Emmanouilidou 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.
- Background: PubMed 35577452Park 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.
- Background: PubMed 35493777Ahmed 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.
- Background: PubMed 30927097Grzywalski 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric McCollum, MD, MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Automated digital stethoscope in people with Respiratory Infections in Children, run by Johns Hopkins University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric D McCollum, MD, MPH (410-955-2035, emccoll3@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07362433, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.