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Blood test could revolutionize TB treatment monitoring

NCT ID NCT06845618

Knowledge-focused Sponsor: University of Oxford Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This study explores whether measuring tiny DNA fragments from the TB bacteria in the blood can help doctors monitor how well treatment is working. Researchers will enroll 140 adults with newly diagnosed TB in Thailand, taking blood samples over time to see if the DNA levels drop as the infection clears. If successful, this approach could replace slower, less sensitive culture tests and speed up drug development.

What this could mean

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

What this could lead to
If successful, this could provide a faster, more sensitive blood test to monitor TB treatment, helping doctors know sooner if therapy is working and aiding new drug development.
What could go wrong
This is an early feasibility study with only 140 participants, so results may not apply broadly. The test may not be accurate enough to replace current methods.

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 140 people

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

Started

Jul 2025

Expected to finish

Sep 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.

Who is studied

Group 1: Assay development and validation. In this group, sampling will be performed at tuberculosis diagnosis. Tuberculosis participants (n = 20) will have blood sampling performed at day 0. Healthy participants (n = 20) without clinical evidence of tuberculosis will have blood sampling performed at a single timepoint. Group 2: Longitudinal Assessment. In this group, tuberculosis participants (n= 120) will have longitudinal sampling performed from diagnosis to the end of treatment. This will help to establish the feasibility of dynamic Mtb-cfDNA measurements.

Ages

18 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: Participants with a new diagnosis of tuberculosis * Aged ≥ 18 years old * Newly microbiologically confirmed (culture or nucleic acid amplification test) diagnosis of Mycobacterium tuberculosis (Mtb.) infection (of any site) * Has not yet commenced antituberculosis therapy * Able to understand study procedures and requirements and is able to give informed consent For healthy volunteers: * Aged ≥ 18 years old * Healthy as judged by a responsible physician * Able to understand study procedures and requirements and is able to give informed consent Exclusion Criteria: Participants with a new diagnosis of tuberculosis * Exposure to antituberculosis treatment in the last 8 weeks (or Mycobacterium tuberculosis (Mtb.) active fluoroquinolone) * Known history of underlying malignancy * Pregnancy * Transfusion dependent anaemia For healthy volunteers: * History of tuberculosis infection or latent tuberculosis infection * Household, or other close contact, of a person living with tuberculosis disease * Chest radiograph (CXR) changes suggestive of pulmonary tuberculosis * Presence of symptoms which would otherwise indicate screening for tuberculosis (cough \> 2 weeks duration, fever, weight loss, night sweats) * Other major medical comorbidity * Pregnancy * Known malignancy

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Conditions

The condition(s) this trial relates to.

extrapulmonary tuberculosis pulmonary tuberculosis tuberculosis Tuberculosis, Extrapulmonary

As listed by the trial registrant

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

Mycobacterium tuberculosis Tuberculosis, extra-pulmonary Tuberculosis, pulmonary

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

  • Shoklo Malaria Research Unit (SMRU)

    RECRUITING

    Tak, Thailand

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