Taking people in NigeriaNo phase

Testing New Ways to Diagnose Tuberculosis More Quickly and Simply

Tests new tuberculosis diagnostic methods in people aged 12 and older.

Key facts

Who runs it: University of California, San Francisco
Where: Abuja, NigeriaSee the siteAlso in 7 other countries, 15 sites
Trial code: NCT04923958
Registry title: Rapid Research in Diagnostics Development for TB Network
Status: Recruiting
People taking part: 26,436 people, planned
Started: 14 Apr 2021
Expected to end: 31 May 2031
Type of study: Interventional, 2 groups
Treatments tested: Novel mycobacterial culture techniques
Novel sputum smear microscopy techniques
Sputum-based molecular assays
Tongue swab-based molecular assays
Urine LAM assays
Blood-based host immune response assays
Breath-based assays
Artificial intelligence-based digital health tools
Phage-based assays
Cartridge-based molecular assays for detecting drug resistance
Sequencing-based assays for detecting drug resistance
Record updated: 9 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for non-hospitalized people aged 12 or older with a long cough or a risk factor for TB, and adults with TB resistant to rifampicin (RIF). Health workers who do TB testing can also join the usability part.

Age: 12 years or older for the test studies; 18 years or older for health workers.
Sex: All
Disease stage: Cough lasting 2 weeks or more, or a TB risk factor (HIV infection, close contact with someone with TB, history of mining work) with a positive TB screen. For the drug-resistance part: TB and RIF resistance found on routine testing.
Earlier treatment: Cannot have finished TB treatment in the past 12 months. Cannot have taken any medicine that acts against mycobacteria (including fluoroquinolones) in the past 2 weeks.
Biomarker or test result: People with a risk factor must screen positive: for HIV, CRP above 5 mg/dL or an abnormal chest X-ray; for close contact or mining work, an abnormal chest X-ray. The drug-resistance part needs TB and RIF resistance on Xpert MTB/RIF, Xpert MTB/RIF Ultra or Hain MTBDRplus.

Main reasons for not taking part

Finished TB treatment within the past 12 months
Took medicine active against mycobacteria within the past 2 weeks
Lives more than 20km (12 mi) from the study site or cannot return for follow-up
Cannot give at least two sputum samples of 3 mL each (drug-resistance part)
Unwilling to give informed consent

The registry criteria, word for word

Show all 13 criteriaShow less

Other criteria

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:
PLHIV (Risk Factor), CRP >5 mg/dL OR abnormal CXR (Positive TB screening definition)
Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition)
History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition); We will exclude people who:
completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively)
have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives)
reside >20km from the study site or are unwilling to return for follow-up visits; or
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:
have negative or contaminated results on all baseline (i.e., enrollment) sputum cultures
are unable to provide at least two sputum specimens of 3 mL each within one day of enrollment
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

Where in Nigeria

Also in 7 other countries, 15 sites

Zankli Research CenterAbuja, NigeriaContact: John Bimba, MDTaking people

About the trial

What the trial wants to find out

To reduce the burden of TB worldwide through more accurate, faster, simpler, and less expensive diagnosis of TB Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) brings together experts in TB care, technology assessment, diagnostics development, laboratory medicine, epidemiology, health economics and mathematical modeling with highly experienced clinical study sites in 10 countries.

The 2 groups in the trial

Evaluation of various novel TB triage and diagnostic tests.Treatment being tested
For the novel TB triage and diagnostic tests, the investigators will conduct large-scale evaluation of design-locked tests in a cohort of adults with presumed TB, with nested feasibility/pilot studies of early and late prototype tests. The investigators aim to enroll 300-450 participants per year at each of five enrollment sites for evaluation of various novel TB triage and diagnostic tests and 50 health workers to assess test usability.
Treatment: Novel mycobacterial culture techniques, Novel sputum smear microscopy techniques, Sputum-based molecular assays, Tongue swab-based molecular assays, Urine LAM assays, Blood-based host immune response assays, Breath-based assays, Artificial intelligence-based digital health tools, and Phage-based assays
Evaluation of novel rDST assaysTreatment being tested
Clinicians at participating sites will be asked to refer adult patients with rifampin-resistance identified by routine molecular testing. The investigators aim to enroll 100-200 patients per year at each of three enrollment sites for evaluation of novel rDST assays.
Treatment: Cartridge-based molecular assays for detecting drug resistance and Sequencing-based assays for detecting drug resistance