Rapid test for diagnosing active tuberculosis
Evaluation of the Feasibility, Accuracy, and Effect of a Rapid Point-of-Care Serological Triage Test for Active TB (SeroSelectTB) in High Burden, HIV-endemic African Settings: a Multi-centre, Parallel-group, Randomised, Controlled Trial
This study is testing a new quick test for diagnosing active tuberculosis in adults to see if it can provide faster results and help start treatment sooner in areas where TB is common.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16682 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Norwegian Institute of Public Health Government |
| Locations | 3 sites (Bahir Dar and 2 other locations) |
| Trial ID | NCT04752592 on ClinicalTrials.gov |
What this trial studies
This study evaluates the performance of a new rapid triage test, SeroSelectTB, for detecting active tuberculosis (TB) in adults suspected of having the disease. Conducted in multiple health-posts across South Africa, Tanzania, and Ethiopia, the trial involves collecting blood and saliva samples for screening, alongside routine sputum tests for TB diagnosis. The goal is to provide same-day diagnosis, reduce diagnostic delays, and improve treatment initiation for patients in high TB-burden areas. Cost-effectiveness evaluations will also be performed to support the test's commercialization and value proposition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are unwell and suspected of having TB or pneumonia.
Not a fit: Patients currently receiving TB treatment or who have been on treatment within the last month may not benefit from this study.
Why it matters
Potential benefit: If successful, this test could lead to quicker and more accurate diagnoses of active TB, ultimately saving lives and reducing transmission rates.
How similar studies have performed: Other studies have shown promise with rapid diagnostic tests for TB, but this specific approach using SeroSelectTB is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years of age or older * Informed Consent Form signed * Unwell, suspected to have TB or pneumonia Exclusion Criteria: * Currently receiving TB treatment * On TB treatment past 30 days or more, or last dose less than 1 month before enrolment
Where this trial is running
Bahir Dar and 2 other locations
- Amhara region — Bahir Dar, Ethiopia (Recruiting)
- Stellenbosch University Clinics — Cape Town, Western Cape, South Africa (Active_not_recruiting)
- Kilimanjaro region, Tanzania — Moshi, Tanzania (Active_not_recruiting)
Study contacts
- Principal investigator: Grant Theron, PhD — University of Stellenbosch
- Study coordinator: Carol Holm-Hansen, PhD
- Email: carol.holm-hansen@fhi.no
- Phone: +4741478643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.