Trial of an AI-enabled Digital Stethoscope to Improve Antibiotic Stewardship
ConditionRespiratory Infections in Children
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-59
SponsorJohns Hopkins University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
prior participation,
age <2 months or >59 months,
illness duration >14 days,
not meeting IMCI-defined non-severe pneumonia criteria,
Trial design
Design model
Parallel
Treatments tested in this trial
Automated digital stethoscope
DeviceThe 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.
Treatment groups
2,500 Participants
are divided into 2 treatment groupsGroup A: IMCI guidelines enhanced by automated digital stethoscopeExperimental treatment 1 intervention
Group B: IMCI guidelines without automated digital stethoscope enhancementNo intervention 0 interventions
Trial outcomes
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.
Time frame
7 daysSecondary outcomes
1
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.
Time frame
7 days2
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.
Time frame
14 days3
Subgroup analysis: Treatment failure stratified by age
Analysis of treatment failure (primary outcome definition) stratified by age
Time frame
7 days4
Subgroup analysis: Treatment failure stratified by sex
Analysis of treatment failure (primary outcome definition) stratified by sex
Time frame
7 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Projahnmo Research Foundation
Collaborator
University College, London
Collaborator
Thomas Jefferson University
Collaborator
University of Washington
Collaborator
Source ClinicalTrials.gov