Status:
NOT_YET_RECRUITING
Evaluating Next Generation LAM Assays and Molecular Diagnostics (POC and Near POC) for the Diagnosis of TB Among People With Presumptive TB: a Prospective Multicentre Diagnostic Accuracy Study
Lead Sponsor:
Foundation for Innovative New Diagnostics, Switzerland
Conditions:
Tuberculosis
Eligibility:
All Genders
18+ years
Brief Summary
This prospective multicentre study is planned to evaluate the next generation LAM assays and molecular diagnostics (POC and near POC) among people with presumptive Tuberculosis. The DriveDx4TB study a...
Detailed Description
Tuberculosis (TB) remains a major global health problem owing to high rates of morbidity and mortality; the 2022 Global TB Report estimates that approximately 10.6 million individuals fell ill with TB...
Eligibility Criteria
Inclusion
- Adult (≥18 years), with presumptive pulmonary TB i.e., self-reporting cough ≥2 weeks and ≥1 other symptom typical of pulmonary TB\*
- Willing to provide written informed consent
- Willing to provide sputum, and other samples (tongue swabs, urine)
- Willingness to have a telephonic follow-up call 2-3 months post-enrolment
- Documented HIV status and CD4 count within last 6 months, or if unavailable, then willing to undergo testing
- fever, night sweats or unintended weight-loss
Exclusion
- Participants currently on anti-TB treatment \*
- Any anti-TB treatment or antibiotics not specifically used for TB treatment, but which have anti-TB activity, e.g., fluoroquinolones given for respiratory tract infection within 60 days prior to enrolment
- Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment
- Participants who have conditions or circumstances that preclude their participation, based on the judgement of the site investigator
- Unable to produce at least 3ml of sputum \* Participants starting anti-TB treatment at the time of enrolment will not be excluded from the study provided that all study specimens are collected before starting the 3rd dose of treatment.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
1890 Patients enrolled
Trial Details
Trial ID
NCT06019052
Start Date
September 1 2025
End Date
December 1 2026
Last Update
June 24 2025
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