NCT06019052Not 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
Testing New Diagnostic Technology Classes for TB (DriveDx4TB)
Source: ClinicalTrials.gov · Last updated 24 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 aims to generate evidence needed to accelerate the introduction of three new classes of TB diagnostics, complemented by alternative sampling for use at primary healthcare and community settings. To this end, the study will leverage the accelerated innovation spurred by the COVID-19 pandemic, particularly the rapid development of swab-based sampling and molecular diagnostic (MDx) platforms.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1890 (estimated)
- First submitted
- 10 Aug 2023
- Start date
- 1 Sept 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Diseases
- Tuberculosis
- NCT number
- NCT06019052
What you commit to
- Study type: Observational
- Planned participants: 1890
- From 1 Sept 2025 to the primary completion date, 31 Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Participants who have conditions or circumstances that preclude their participation, based on the judgement of the site investigator
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.