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Massive global study aims to slash TB deaths with smarter testing

NCT ID NCT04923958

Diagnosis Sponsor: University of California, San Francisco 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to find faster, simpler, and cheaper ways to diagnose tuberculosis (TB), a disease that kills over a million people each year. Researchers will test new diagnostic tools on over 26,000 adults in 10 countries who have a cough lasting two weeks or more, or who have risk factors like HIV or close contact with TB. The goal is to improve detection so that more people get treated sooner.

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 26,436 people

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

Started

Apr 2021

Expected to finish

May 2031

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

12 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.

Novel TB triage and diagnostic tests: We will include non-hospitalized adults (age ≥ 12 years) with either 1) cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups or 2) risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below: Positive TB screening definitions by risk factor: 1. PLHIV (Risk Factor), CRP \>5 mg/dL OR abnormal CXR (Positive TB screening definition) 2. Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition) 3. History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition) We will exclude people who: 1. completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively); 2. have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives); 3. reside \>20km from the study site or are unwilling to return for follow-up visits; or 4. are unwilling to provide informed consent Novel TB rDST assays: We will include adults (age ≥12 years) who are positive for TB and RIF resistance according to routine diagnostic testing (based typically on Xpert MTB/RIF, Xpert MTB/RIF Ultra, or Hain MTBDRplus). We will exclude people who: 1. have negative or contaminated results on all baseline (i.e., enrollment) sputum cultures 2. are unable to provide at least two sputum specimens of 3 mL each within one day of enrollment 3. are unable or unwilling to provide informed consent Assessment of the usability of novel TB tests: We will include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). We will exclude staff who are unwilling to provide informed consent.

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Conditions

The condition(s) this trial relates to.

pulmonary tuberculosis rifampicin-resistant tuberculosis tuberculosis

As listed by the trial registrant

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

Tuberculosis

How to take part

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

  1. The places running it

    16 sites in 8 countries. 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

  • Brooklyn Chest Hospital

    RECRUITING

    Cape Town, South Africa

  • Centre for Infectious Disease Research in Zambia

    RECRUITING

    Lusaka, Zambia

  • Chitoor (Christian Medical College satellite campus)

    RECRUITING

    Vellore, India

  • Christian Medical College CMC Pulmonary Outpatient Department

    RECRUITING

    Vellore, India

  • De La Salle Medical and Health Sciences Institute

    RECRUITING

    Dasmariñas, Philippines

  • Hanoi Lung Hospital, Outpatient departments

    RECRUITING

    Hanoi, Vietnam

  • Khayelitsha District Health Center

    RECRUITING

    Cape Town, South Africa

  • Kisenyi Health Center

    RECRUITING

    Kampala, Uganda

  • Kraaifontein Community Health Clinic

    RECRUITING

    Cape Town, South Africa

  • Mulago Outpatient Department

    RECRUITING

    Kampala, Uganda

  • National Center for Tuberculosis and Lung Diseases

    RECRUITING

    Tbilisi, Georgia

  • National Lung Hospital, Outpatient departments

    RECRUITING

    Hanoi, Vietnam

  • Primary care clinics (Shalom/LCC, CHAD)

    RECRUITING

    Vellore, India

  • Scottsdene primary care clinic

    RECRUITING

    Cape Town, South Africa

  • Wallacedene primary care clinic

    RECRUITING

    Cape Town, South Africa

  • Zankli Research Center

    RECRUITING

    Abuja, Nigeria

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