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Massive global study aims to speed up TB diagnosis at local clinics

NCT ID NCT05845112

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study tested several tuberculosis (TB) diagnostic tools in over 14,000 people across seven countries. The goal was to find tests that are accurate enough to use in local clinics, without needing special lab equipment. Researchers looked at a simple blood test for C-reactive protein (CRP) and other combinations to see which works best for different groups, including people with HIV and children.

What this could mean

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

Active substance
C-Reactive Protein (CRP) point-of-care test
What this could lead to
If successful, this could lead to simpler, more accurate TB tests that work in local clinics, helping more people get diagnosed and treated sooner.
What could go wrong
This is a diagnostic accuracy study, not a treatment trial. Even if tests perform well, they still need to be rolled out and used effectively in real-world settings.

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

14,747 people

The number who actually took part.

Started

Feb 2025

Finished

Mar 2025

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

Individuals suspected of having TB.

Ages

1 year 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.

1. Inclusion criteria for Individuals attending stationary health facilities: health-seeking persons presenting at participating study site health facilities who are: * Age 15 years and above * PLHIV irrespective of their CD4 count and antiretroviral therapy (ART) status * At risk of pulmonary and/or extra-pulmonary TB OR * People with a positive WHO-recommended four-symptom screen (W4SS) or parenchymal abnormalities on chest radiography * Written informed consent and agreement to follow-up after enrolment (e.g. not planning to relocate) * A parent or guardian present at the time of enrolment to provide signed informed consent and assent signed for those aged 15 years to age of majority • Exclusion * Current anti-TB treatment (counting from the third dose) * Any anti-TB treatment within 60 days prior to enrolment * Any TB preventive therapy within 6 months prior to enrolment 2. Inclusion criteria for refugees and IDPs * health-seeking persons resident in official refugee camps who have cross international borders from other countries; OR * internally displaced individuals (IDPs), defined as persons forced or obliged to flee or to leave their homes to avoid the effects of armed conflict, situations of generalized violence, violations of human rights or natural or human-made disasters, and who have not crossed an internationally recognized state border. * IDPs can be recruited from refugee camps or among individuals sharing accommodation with local residents. * At the time they are presenting at participating study site health facilities. * Clinical criteria will be the same as described for individuals attending health facilities • Exclusion * Same as described for individuals attending health facilities and * Individuals who intend to leave the local area in the short term and have no means of contact 3. Inclusion criteria for nomadic populations * Participants will be selected using active case finding through community screening camps targeting the nomadic population (nomadic are defined as a member of a group of people who have no fixed home and move according to the seasons from place to place in search of food, water, and grazing land and are usually herders with traditional hierarchies. * The dates and locations of screening days will coincide with community market days, after consultation with nomadic community leaders * Clinical criteria will be the same as described for individuals attending health facilities • Exclusion * Same as described for individuals attending health facilities and Individuals who intend to leave the local area in the short term and have no means of contact 4. Inclusion criteria for informal settlements, urban vulnerable groups and the rural poor * Participants will be selected using active case finding through community screening activities targeting urban vulnerable groups and the rural poor. * Screening will be conducted on dates and in locations agreed with community leaders, depending on the setting. * Clinical criteria will be the same as described for individuals attending health facilities. • Exclusion * Same as described for individuals attending health facilities and Individuals who intend to leave the local area in the short term and have no means of contact. 5. Inclusion criteria for children health-seeking children presenting at participating study site health facilities who: * Are between 12 months and 15 years of age. * Have presumptive TB based on at least one criterion among the following: * Persistent cough for more than 2 weeks * Persistent fever for more than 2 weeks * Recent failure to thrive (documented clear deviation from a previous growth trajectory in the last 3 months or Z score weight/age \< 2) * Failure of broad-spectrum antibiotics for treatment of pneumonia to improve symptoms and signs * Suggestive CXR features OR * History of contact with a person with TB and any of the symptoms listed above with a shorter duration (\< 2 weeks), if the child is HIV infected or presents with Severe Acute Malnutrition * A parent or guardian present at the time of enrolment to provide signed informed consent and assent signed by children \> 7 years old. * \> 5 days of anti-TB treatment in the last 3 months or individuals receiving TB preventive therapy * Children \<12 months old

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • CHPR

    Bamenda, Cameroon

  • Friends for International TB Relief

    Hà Nội, Vietnam

  • Fundação de Apoio à Pesquisa e Extensão de Sergipe

    Sergipe, Brazil

  • Icddr,B

    Dhaka, Bangladesh

  • Janna Health Foundation

    Adamawa, Nigeria

  • KEMRI

    Kisumu, Kenya

  • Malawi-Liverpool-Wellcome Clinical

    Blantyre, Malawi

  • Zankli Research Centre, Bingham University

    Abuja, Nigeria

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