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New blood test could revolutionize TB treatment monitoring

NCT ID NCT07157904

Knowledge-focused Sponsor: Nagasaki University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study in Kenya will test whether a new blood test, called PATHFAST TB LAM ag, can better track how well tuberculosis (TB) treatment is working. Researchers will follow 300 adults with TB, collecting samples regularly during their 6-month treatment. The goal is to see if changes in a substance called LAM can predict treatment success or failure earlier than current methods.

What this could mean

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

Active substance
PATHFAST TB LAM ag assay (a blood test for LAM, a substance from TB bacteria)
What this could lead to
If successful, this test could provide a faster, simpler way to monitor TB treatment, helping doctors catch problems early and improve recovery rates.
What could go wrong
This is an early observational study with only 300 participants, so results may not apply to all TB patients. The test's accuracy in real-world settings is still unproven.

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 300 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jul 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

To ensure a representative sample reflecting a broad spectrum of TB disease severity and healthcare access, investigators will recruit participants from multiple healthcare facilities at different levels of the Kenyan health system. The primary study sites include Rhodes Chest Clinic (RCC) and Mbagathi County Referral Hospital (MCH). RCC is a Level 2 healthcare facility which serves as a specialized primary care center for TB patients, recording approximately 700-800 new PTB cases every year. MCH is a Level 5 referral hospital offering both outpatient and inpatient care with a bed capacity of around 150. MCH manages 1,000 new TB cases annually.

Ages

18 years and older

Sex

Anyone

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: * Adults aged 18 years or older * Patients with a recent diagnosis of bacteriologically confirmed PTB who have not yet initiated TB treatment. * Patients who are willing and able to visit to the facility for follow-up sample collection and interviews. * Patients who are willing and able to provide written informed consent to participate in the study. Exclusion Criteria: \- Patients with a history of TB treatment within the past 6 months, including retreatment.

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Conditions

The condition(s) this trial relates to.

pulmonary tuberculosis tuberculosis

As listed by the trial registrant

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

Mycobacterium tuberculosis Pulmonary tuberculoses Tuberculosis

How to take part

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

  1. The places running it

    2 sites. 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

  • Mbagathi County Referral Hospital

    Nairobi, Kenya

  • Rhodes Chest Clinic

    Nairobi, Kenya

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