Diarrhea InfectiousNCT07538531
The Utility and Feasibility of Accessible Diarrhea Etiology Prediction Tool (ADEPT) in an Informal Healthcare Setting
A study testing Diagnostic test: Accessible Diarrhea Etiology Prediction Tool (ADEPT) in people with Diarrhea Infectious and Algorithms, run by Daniel Leung at 1 site in Bangladesh.
Trial summary
Diarrheal disease remains a leading cause of morbidity and mortality for children under 5 globally. Accepted best practice for managing diarrhea in the absence of blood or suspicion of cholera is rehydration, however in resource poor areas antibiotics are still prescribed at high rates due to pressures such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea Infectious, Algorithms, Decision Support Systems, Clinical
- What is being tested?
- Diagnostic test: Accessible Diarrhea Etiology Prediction Tool (ADEPT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBangladesh
- Study dates
- 12 Apr 2026to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Village Doctor with antibiotic prescribing authority for children presenting with diarrheal illness
- Practice in trial location subdistrict
- Self-report treating a minimum of 5 pediatric diarrhea cases per week
- Willing to participate in ADEPT training, use ADEPT in clinical practice with pediatric diarrhea patients, and to collect, via an electronic tool, data on patient characteristics and clinical management
Who cannot join
- Planning to leave study site prior to completion of study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mobile Health Tool to Improve Antibiotics Stewardship Among Village Doctors in Bangladesh
Diarrheal disease remains a leading cause of morbidity and mortality for children under 5 globally. Accepted best practice for managing diarrhea in the absence of blood or suspicion of cholera is rehydration, however in resource poor areas antibiotics are still prescribed at high rates due to pressures such as financial incentives, caregiver expectations, and diagnostic uncertainty. Informal healthcare providers often serve as first point of care for pediatric diarrhea patients in low- and middle- income countries (LMICs) and commonly prescribe antibiotics for pediatric diarrhea at high frequencies.
In this pilot before-after feasibility trial informally trained healthcare providers will use a mobile phone-based application (Accessible Diarrhea Etiology Prediction Tool, ADEPT) which will allow for the exploration of the acceptability, feasibility, and utility of the tool, as well as ADEPTs ability to decrease inappropriate antibiotic prescribing practices.
Read the detailed description
Diarrheal diseases remain a leading cause of morbidity and mortality in children worldwide, accounting for around 500,000 deaths in children under 5 annually. Generally, the management of diarrheal disease relies on rehydration, although other management decisions such as laboratory testing and medication may alter outcome. However, in many low- and middle-income countries (LMICs) where the burden of diarrheal disease is highest, treatment is largely empiric due to high caseloads and lack of accessible and affordable diagnostics. Despite World Health Organization (WHO) guidelines, antibiotics are often overused in management of diarrheal disease leading to adverse side effects and antimicrobial resistance. Meanwhile underuse of antibiotics may result in prolonged illness and increased transmission rates. In resource poor areas with limited access to diagnostics antibiotic overuse is common, especially when prescribed by untrained allopathic providers. Accurate and timely determination of etiology is essential to reduce unnecessary diagnostic and antibiotic use. Clinical prediction rules (CPRs), often in the form of electronic clinical decision-making support tools (eCDSTs), are used to help clinicians make evidence-based decisions with improved patient outcomes. Informally trained allopathic providers, known as Village Doctors (VDs) in Bangladesh, often function as the first point of care for pediatric diarrhea patients. VDs are immensely popular due to enhanced accessibility and familiarity; a recent study in rural Bangladesh found that VDs act as first point of care for up to 65% of patients. VDs and other informally trained practitioners prescribe antibiotics for pediatric diarrhea at rates far exceeding formally trained providers and far beyond what is clinically indicated.
The reliance on VDs, especially in resource poor settings, and their prescribing practices suggests that antimicrobial stewardship efforts should include VDs. A previous study by the investigators has shown that an eCDST based on etiologic prediction rules and WHO guidelines was successful in reducing antibiotics prescribed by formally trained providers by over 50%. Our investigation will seek to understand if an eCDST (the Accessible Diarrhea Etiology Prediction Tool (ADEPT)) could be used to guide antibiotic prescriptions by informally trained healthcare providers like VDs.
- Conditions
- Diarrhea Infectious, Algorithms, Decision Support Systems, Clinical, Clinical Decision-making
- Being tested
- Diagnostic test: Accessible Diarrhea Etiology Prediction Tool (ADEPT)
- Keywords
- Diarrhea, Treatment Algorithm, mHealth, Antimicrobial stewardship
- Medical subject headings
- Dysentery, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test: Accessible Diarrhea Etiology Prediction Tool (ADEPT)Diagnostic test
The ADEPT tool allows providers to input information about pediatric diarrhea patients and provides outputs related to dehydration management and potential treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Diarrheal assessment with ADEPT, mobile phone tool | Experimental | Not described Receives: Diagnostic Test: Diagnostic test: Accessible Diarrhea Etiology Prediction Tool (ADEPT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of pediatric diarrhea encounters resulting in antibiotic prescription
By self-report, before vs after ADEPT implementation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start12 Apr 2026
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea InfectiousStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Leung
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor-investigator, Daniel Leung, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538531
- Sponsor's protocol ID
- IRB_00158579
- Other IDs
- R33HD109819-04
- Status last verified
- Sep 2026
- First submitted
- 13 Apr 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Health Tool to Improve Antibiotics Stewardship Among Village Doctors in Bangladesh
- ClinicalTrials.gov ID
- NCT07538531
- Acronym / sponsor ID
- IRB_00158579
- Conditions
- Diarrhea Infectious, Algorithms, Decision Support Systems, Clinical, Clinical Decision-making
- Keywords
- Diarrhea, Treatment Algorithm, mHealth, Antimicrobial stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Daniel LeungUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 12 Apr 2026 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 20 Apr 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.
Diarrheal disease remains a leading cause of morbidity and mortality for children under 5 globally. Accepted best practice for managing diarrhea in the absence of blood or suspicion of cholera is rehydration, however in resource poor areas antibiotics are still prescribed at high rates due to pressures such as financial incentives, caregiver expectations, and diagnostic uncertainty. Informal healthcare providers often serve as first point of care for pediatric diarrhea patients in low- and middle- income countries (LMICs) and commonly prescribe antibiotics for pediatric diarrhea at high frequencies.
In this pilot before-after feasibility trial informally trained healthcare providers will use a mobile phone-based application (Accessible Diarrhea Etiology Prediction Tool, ADEPT) which will allow for the exploration of the acceptability, feasibility, and utility of the tool, as well as ADEPTs ability to decrease inappropriate antibiotic prescribing practices.
Detailed description
Diarrheal diseases remain a leading cause of morbidity and mortality in children worldwide, accounting for around 500,000 deaths in children under 5 annually. Generally, the management of diarrheal disease relies on rehydration, although other management decisions such as laboratory testing and medication may alter outcome. However, in many low- and middle-income countries (LMICs) where the burden of diarrheal disease is highest, treatment is largely empiric due to high caseloads and lack of accessible and affordable diagnostics. Despite World Health Organization (WHO) guidelines, antibiotics are often overused in management of diarrheal disease leading to adverse side effects and antimicrobial resistance. Meanwhile underuse of antibiotics may result in prolonged illness and increased transmission rates. In resource poor areas with limited access to diagnostics antibiotic overuse is common, especially when prescribed by untrained allopathic providers. Accurate and timely determination of etiology is essential to reduce unnecessary diagnostic and antibiotic use. Clinical prediction rules (CPRs), often in the form of electronic clinical decision-making support tools (eCDSTs), are used to help clinicians make evidence-based decisions with improved patient outcomes. Informally trained allopathic providers, known as Village Doctors (VDs) in Bangladesh, often function as the first point of care for pediatric diarrhea patients. VDs are immensely popular due to enhanced accessibility and familiarity; a recent study in rural Bangladesh found that VDs act as first point of care for up to 65% of patients. VDs and other informally trained practitioners prescribe antibiotics for pediatric diarrhea at rates far exceeding formally trained providers and far beyond what is clinically indicated.
The reliance on VDs, especially in resource poor settings, and their prescribing practices suggests that antimicrobial stewardship efforts should include VDs. A previous study by the investigators has shown that an eCDST based on etiologic prediction rules and WHO guidelines was successful in reducing antibiotics prescribed by formally trained providers by over 50%. Our investigation will seek to understand if an eCDST (the Accessible Diarrhea Etiology Prediction Tool (ADEPT)) could be used to guide antibiotic prescriptions by informally trained healthcare providers like VDs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Diarrheal assessment with ADEPT, mobile phone tool | Experimental | Diagnostic Test: Diagnostic test: Accessible Diarrhea Etiology Prediction Tool (ADEPT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Village Doctor with antibiotic prescribing authority for children presenting with diarrheal illness
- Practice in trial location subdistrict
- Self-report treating a minimum of 5 pediatric diarrhea cases per week
- Willing to participate in ADEPT training, use ADEPT in clinical practice with pediatric diarrhea patients, and to collect, via an electronic tool, data on patient characteristics and clinical management
Key exclusion criteria (1 listed)
- Planning to leave study site prior to completion of study
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 |
|---|---|---|
| Diagnostic test: Accessible Diarrhea Etiology Prediction Tool (ADEPT)The ADEPT tool allows providers to input information about pediatric diarrhea patients and provides outputs related to dehydration management and potential treatment. | Diagnostic test | Experimental: Diarrheal assessment with ADEPT, mobile phone tool |
Primary outcome
Proportion of pediatric diarrhea encounters resulting in antibiotic prescription
Time frame: 6 weeks
By self-report, before vs after ADEPT implementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic test: Accessible Diarrhea Etiology Prediction Tool (ADEPT) in people with Diarrhea Infectious and Algorithms, run by Daniel Leung 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 1 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: finished, as of the sponsor's last update on 8 Oct 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of pediatric diarrhea encounters resulting in antibiotic prescription (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2026.