NCT07538531

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

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

Study Progress32%
Apr 2026Jun 2026

Study Start

First participant enrolled

April 12, 2026

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

DiarrheaTreatment AlgorithmmHealthAntimicrobial stewardship

Outcome Measures

Primary Outcomes (1)

  • Proportion of pediatric diarrhea encounters resulting in antibiotic prescription

    By self-report, before vs after ADEPT implementation

    6 weeks

Study Arms (1)

Experimental: Diarrheal assessment with ADEPT, mobile phone tool

EXPERIMENTAL
Diagnostic Test: Diagnostic test: Accessible Diarrhea Etiology Prediction Tool (ADEPT)

Interventions

The ADEPT tool allows providers to input information about pediatric diarrhea patients and provides outputs related to dehydration management and potential treatment.

Experimental: Diarrheal assessment with ADEPT, mobile phone tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Planning to leave study site prior to completion of study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

DysenteryDiarrhea

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Internal Medicine

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

April 12, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share