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New rapid swab test could transform TB diagnosis in remote areas

NCT ID NCT07420881

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study will test a new, portable device that can detect tuberculosis (TB) in about 15-35 minutes using a simple tongue or sputum swab. It aims to enroll 60,000 people in Bangladesh, Cameroon, and Nigeria who are screened in community settings. The goal is to see if this rapid test works as well as standard lab tests, especially for people who have trouble producing sputum.

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 nucleic acid amplification test (NPOC NAAT) using tongue or sputum swabs
What this could lead to
If successful, this could make TB diagnosis faster and more accessible in communities, especially for people who cannot produce sputum.
What could go wrong
This is a diagnostic accuracy study, not a treatment trial. The test may not perform as well as lab-based methods, and results may vary across different populations.

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 60,000 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Oct 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

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: 1. Age: * Adults aged 15 years and above * Young adolescents aged 10-14 years 2. Community setting: o Rural and urban poor, elderly, marginalized groups, internally displaced persons (IDP) in camps and host communities, nomadic communities, and contacts of people with TB who attend community-based case finding (CBCF) campaigns. 3. Screening eligibility: * Screen positive on CAD CXR-AI (CAD score threshold ≥ 0.3). 4. Consent: * Written informed consent (and assent for adolescents if recruited) 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 with CAD CXR-AI (CAD score threshold \<0.3). 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 St * Fever \>39°C * Pulse rate \>120/min * Inability to walk unaided 7. Duplicate enrolment o Previous enrolment in DARE-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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

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