Could a swab or a cough sound diagnose TB in kids?

NCT ID NCT05989802

Diagnosis Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study is testing new, non-invasive ways to diagnose tuberculosis (TB) in children under 15. Researchers will evaluate oral swabs, cough sound analysis, and lung sound analysis as potential alternatives to sputum tests. The goal is to find faster, simpler, and cheaper diagnostic tools to help reduce the 230,000 childhood TB deaths that occur each year. The study will enroll about 2,100 children at clinics in high-burden settings.

What this could mean

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

Active substance: Oral swab molecular testing, automated cough sound analysis, automated lung sound analysis
What this could lead to: If successful, these tests could provide faster, simpler, and cheaper ways to diagnose TB in children, potentially saving many young lives.
What could go wrong: This is a diagnostic accuracy study, not a treatment trial. The new tests may not be accurate enough to replace current methods, and results may not apply to all settings.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,100 people

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

Started

Jan 2024

Expected to finish

Sep 2026

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

Up to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Participant eligibility criteria: Participants will include children (age \<15 years) who present to care with: A. 2 or more of the following: * Unexplained cough for any duration * TB contact or tuberculin skin test or interferon gamma release assay positive * Abnormal chest X-ray (any abnormality) OR B. Any one of criteria A AND any one of the following: * Unexplained weight loss OR unexplained failure to thrive OR Severe Acute Malnutrition * Unexplained fever ≥2 weeks * Unexplained lethargy or reduced playfulness ≥2 weeks The study will exclude participants who: 1. Completed preventive or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively); 2. Have taken any medication with anti-mycobacterial activity for any reason for greater than 3 days at the time of enrollment (to reduce false-negatives); 3. Are unable to return for follow-up visits; or 4. Whose parents/guardians are unwilling to provide informed consent or who are unwilling to provide assent if applicable (age determined by local IRB) Assessment of the usability of novel TB tests: The study will also include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). Personnel who are unwilling to provide informed consent will be excluded.

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Conditions

The condition(s) this trial relates to.

tuberculosis

As listed by the trial registrant

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

Diagnostics Global health Tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites in 3 countries. The list below names each one and where it is.
The official record

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

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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.

Could a swab or a cough sound diagnose TB in kids?

What the study statuses mean