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AI stethoscope aims to cut unnecessary antibiotics in kids with cough

NCT ID NCT07631377

Diagnosis Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study tests whether an AI-powered digital stethoscope can help health workers more accurately diagnose pneumonia in children aged 2 months to 5 years. 350 children with cough or breathing difficulty will be randomly assigned to standard care or care plus the AI stethoscope. The goal is to see if the AI tool improves diagnosis and reduces unnecessary antibiotic use, which contributes to antibiotic resistance.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
StethoMe AI-enabled digital stethoscope
What this could lead to
If successful, this could lead to more accurate pneumonia diagnosis in children, reducing unnecessary antibiotic use and helping combat antibiotic resistance.
What could go wrong
This is a Phase 4 study with 350 children in one location, so results may not apply everywhere. The AI results are not used in care, so no direct benefit to participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 59 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 2 to 59 months at the time of screening * Presence of cough and/or difficulty breathing * No WHO-defined emergency/danger signs (e.g., grunting, cyanosis, apnea, convulsions, or altered level of consciousness) * A legal caregiver is present, able to understand the study information, and willing to provide written informed consent * Caregiver is willing and able to provide contact information (e.g., mobile phone number) to allow 7-day follow-up after the clinic visit Exclusion Criteria: * Presence of WHO-defined emergency signs requiring immediate referral or hospital admission (grunting, cyanosis, apnea, uncompensated shock, convulsions, diarrhea with severe dehydration, or altered level of consciousness) * Critical illness or clinical instability judged by the screening clinician or study physician to require urgent medical attention * Age outside the target range (younger than 2 months or older than 59 months) * Previous enrollment in the study * Refusal or withdrawal of informed consent by the legal caregiver at any time prior to randomization

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Conditions

The condition(s) this trial relates to.

bronchiolitis pneumonia pulmonary tuberculosis Respiratory Sounds respiratory tract infectious disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antibiotic resistant strain Bronchiolitis Pneumonia Respiratory sounds Respiratory tract infections Tuberculosis, pulmonary

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.