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

Launched by FOUNDATION FOR INNOVATIVE NEW DIAGNOSTICS, SWITZERLAND · Aug 24, 2023

Keywords

ClinConnect Summary

This clinical trial, called the DriveDx4TB study, is designed to test new tests for diagnosing tuberculosis (TB) in people who might have the disease. The study aims to evaluate updated diagnostic tools that can help identify TB more quickly and easily, especially in community healthcare settings. Researchers will use various samples, like sputum (the mucus you cough up) and tongue swabs, to see how effective these new tests are compared to traditional methods.

To be eligible for this study, participants must be adults (18 years or older) who have symptoms suggesting they might have TB, such as a cough lasting more than two weeks and other related symptoms like fever or weight loss. They should also be willing to provide samples and participate in a follow-up call a few months after joining the study. It’s important to note that individuals currently receiving treatment for TB or certain antibiotics within the last two months will not be eligible. If you join the study, you will help advance our understanding of TB testing, which can lead to better and faster diagnoses for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.