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New TB test could speed up detection of Drug-Resistant strains

NCT ID NCT05117788

Diagnosis Sponsor: Foundation for Innovative New Diagnostics, Switzerland 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 evaluates a new PCR test (Bioneer Q-RFIA kit) for quickly and accurately detecting tuberculosis (TB) and resistance to key antibiotics. About 2,350 adults with TB symptoms will provide samples to see how well the test works compared to standard methods. The goal is to provide a single test that can guide effective treatment, especially for drug-resistant TB.

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 2,350 people

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

Started

Feb 2022

Expected to finish

Jun 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

Participants in whom pulmonary TB is suspected. Additionally, well-characterized samples from existing biobanks may be included in the study to supplement drug-resistant cases.

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: People (aged ≥18 years) with clinical signs and symptoms of pulmonary TB including cough of any duration and ≥1 other symptom typical of pulmonary TB Exclusion criteria comprise absence of informed consent, insufficient sample volume or number, only extra-pulmonary TB signs \& symptoms, and receipt of any dose of TB treatment within six months prior to enrolment (for objectives relating to MTB detection). Exclusion Criteria: Participants will be excluded from the study if any of the following apply: * Unwilling or unable to provide informed consent; * Unwilling to provide two sputum specimens at enrolment; * Presenting with only extra-pulmonary TB signs \& symptoms; * Receipt of any TB treatment dose within the 6 months prior to enrolment.

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Conditions

The condition(s) this trial relates to.

multidrug-resistant tuberculosis pulmonary tuberculosis

As listed by the trial registrant

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

Tuberculosis, multidrug-resistant

Contacts and locations

Locations

  • Centre for Infectious Disease Research in Zambia

    Lusaka, Zambia

  • Institute of Pneumology "Chiril Draganiuc"

    Chisinau, Moldova

  • Instituto de Medicina Tropical Alexander von Humboldt - Universidad Peruana Cayetano Heredia

    Lima, Peru

  • KEMRI

    Nairobi, Nairobi County, Kenya

  • V.N Karazin Kharkiv National University

    Kharkiv, 61064, Ukraine

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