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Pee test could spot TB patients skipping meds

NCT ID NCT06526221

Knowledge-focused Sponsor: Tufts 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
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study in India will test a low-cost urine check (IsoScreen) on 900 adults being treated for tuberculosis. The test detects whether they have taken their medication recently. Researchers want to see if the test can reliably find people who are missing doses, so that doctors can offer extra help. The goal is to reduce deaths, treatment failure, and TB coming back.

What this could mean

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

Active substance
urine isoniazid test (IsoScreen)
What this could lead to
If successful, this could give doctors a cheap, quick way to spot when TB patients miss their pills, allowing them to offer extra support and reduce deaths or relapse.
What could go wrong
This is an observational study, not a treatment trial. The test may not work well in routine clinic visits, and even if it detects missed doses, it may not improve outcomes on its own.

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 900 people

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

Started

Apr 2026

Expected to finish

Apr 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.

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: 1. 18+ years of age, 2. presumed or confirmed drug-susceptible pulmonary TB (with or without a previous TB history), and 3. taking an isoniazid-containing TB regimen. Exclusion Criteria: 1. inability to provide informed consent, or 2. drug-resistant TB diagnosis or switch to another non-isoniazid-containing regimen (Note that this second exclusion criteria may result in retrospective exclusion from the study).

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Conditions

The condition(s) this trial relates to.

Medication Adherence pulmonary tuberculosis

As listed by the trial registrant

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

Medication adherence 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

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  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

  • ICMR-National Institute for Research in Tuberculosis (ICMR-NIRT)

    Chennai, Tamil Nadu, India

  • ICMR-National Institute for Research in Tuberculosis (ICMR-NIRT)

    Thanjavur, Tamil Nadu, India

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