Could a tongue swab replace sputum tests for TB?
NCT ID NCT05941052
First seen Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times
Summary
Every year, millions of people with tuberculosis (TB) go undiagnosed. This study tests new, faster diagnostic tools that use a simple tongue swab instead of the usual sputum sample. Researchers will enroll 1,350 adults with cough or TB risk factors to see how accurate these point-of-care tests are compared to standard lab cultures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tongue swab-based molecular assays
- What this could lead to
- If successful, this could lead to quick, easy, and affordable TB tests that can be used at clinics or community sites, helping diagnose more people early.
- What could go wrong
- This is a diagnostic accuracy study, not a treatment trial. The tests may not be sensitive or specific enough to replace current methods, and results may vary across different populations.
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
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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
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About 1,350 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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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
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12 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: Inclusion Criteria- The investigators 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. People Living with Human Immunodeficiency Virus (PLHIV) (Risk Factor): C Reactive Protein (CRP) \>5 mg/dL OR abnormal chest x-ray (CXR) 2. Self-reported Close Contact (Risk Factor): abnormal CXR History of mining work (Risk Factor): abnormal CXR Exclusion Criteria- 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 Assessment of the usability of novel TB tests: Inclusion Criteria- The investigators 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). Exclusion Criteria- The investigators will exclude staff who are: 1\) unwilling to provide informed consent
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Centre for Infectious Disease Research in Zambia
RECRUITINGLusaka, Zambia
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De La Salle Medical and Health Sciences Institute
RECRUITINGDasmariñas, Philippines
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Zankli Research Center, Bingham University
RECRUITINGAbuja, Nigeria
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can starting TB treatment immediately save lives in HIV sepsis?
- Can a 4-Drug combo cut TB treatment time in half?