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Could a tongue swab replace sputum tests for TB?

NCT ID NCT07517471

Diagnosis Sponsor: Liverpool School of Tropical Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This large study in five countries will test new, portable diagnostic tools for tuberculosis (TB) that use tongue swabs and AI-assisted chest X-rays. The goal is to see if these faster, easier tests can find more TB cases, especially in people who have no symptoms or can't produce sputum. The trial will enroll about 37,000 adults and adolescents at health facilities in Bangladesh, Cameroon, Kenya, Nigeria, and Vietnam.

What this could mean

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

Active substance
Near point-of-care NAATs and low-complexity NAATs (diagnostic tests)
What this could lead to
If successful, this could make TB diagnosis faster and easier, catching more cases early and reducing spread in communities.
What could go wrong
The new tests may be less accurate than current methods, and the trial is still in early stages. Results may vary across different countries and 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 37,000 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2027

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

10 years and older

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.

Inclusion Criteria: 1. Age * Adults aged 15 years and above or * Adolescents aged 10-14 years 2. Facility setting o Participating healthcare facilities (e.g., primary health centres, district hospitals), including both rural and urban facilities. 3. Screening eligibility o All individuals presenting to the facility, regardless of symptoms or ability to produce sputum, will be eligible for inclusion. 4. Consent * Written informed consent (and assent for adolescents (10-14 years) and adults (≥15 - 17 years) if included) must be obtained according to local ethics and regulatory requirements. Exclusion Criteria: 1. Age o Below 10 years at enrolment 2. Screening eligibility o Do not screen positive on any tools. 3. Consent and follow-up o Unable or unwilling to provide written informed consent (and assent where applicable) or unwilling to agree to follow-up visits. 4. Current TB treatment o Receiving anti-TB treatment at the time of enrolment, defined as having taken ≥3 doses of TB treatment. 5. Recent TB preventive therapy o Receipt of TB preventive therapy within the last 6 months prior to enrolment. 6. Clinical danger signs o Presence of severe illness at screening, including but not limited to: Respiratory rate \>30/min Fever \>39°C Pulse rate \>120/min Inability to walk unaided 7. Duplicate enrolment o Previous enrolment in SCREEN-TB.

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Conditions

The condition(s) this trial relates to.

latent tuberculosis infection tuberculosis

As listed by the trial registrant

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

TB - tuberculosis

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

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More trials for these conditions

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