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A rapid test to solve the TB lymph node puzzle

NCT ID NCT07778082

Diagnosis Sponsor: Research Center Borstel 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Sep 01, 2026 · Updated 2 times

Summary

This study tests whether a molecular assay (MBLA) can tell apart two causes of swollen lymph nodes in people being treated for extrapulmonary tuberculosis: a paradoxical immune reaction (IRIS) or actual treatment failure. Researchers will compare MBLA results from routine lymph node samples with standard culture and Xpert tests, and track patient outcomes. If accurate, MBLA could offer a faster, culture-free way to guide treatment decisions and avoid unnecessary changes.

What this could mean

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

Active substance
Molecular Bacterial Load Assay (MBLA) on lymph node aspirates
What this could lead to
If successful, this test could help doctors quickly tell whether swollen lymph nodes during TB treatment are a sign of treatment failure or a harmless immune reaction, reducing unnecessary treatment changes.
What could go wrong
This is a diagnostic study, not a treatment trial. The test's accuracy is still being evaluated, and it may not perfectly match culture results or predict patient outcomes in all cases.

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.

Participants

About 100 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

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.

Who is studied

Patients with tuberculosis and progressive or persistant lymphadenopathy after at least 3 months of TB treatment will be recruited at the study sites. Eligible patients will be contacted by the clinicians responsible for TB treatment and/or follow-up care or by the local principal investigator.

Ages

18 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: * Patient with extrapulmonary tuberculosis * Progressive or persistant lymphadenopathy * Treatment for tuberculosis for at least 3 months * Age ≥ 18 years * Capacity to provide informed consent * Written informed consent to participate in the study Exclusion Criteria: * Lack of capacity to provide informed consent * Age \< 18 years

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Conditions

The condition(s) this trial relates to.

extrapulmonary tuberculosis Lymphadenopathy Tuberculosis, Extrapulmonary

As listed by the trial registrant

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

Extrapulmonary tuberculosis

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Research Center Borstel, Leibniz Lung Center

    Borstel, 23845, Germany

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