NCT06019052

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)

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,890 (estimated)
• Sponsor: Foundation for Innovative New Diagnostics, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 in 2021, however on account of existing programme inefficiencies and compounded by the effects of COVID-19, 4.1 million people with TB went undiagnosed. Access to diagnostics remains a significant barrier to TB care, further exacerbated by COVID-19; the consequence of delayed diagnoses and subsequent treatment has resulted in increased TB deaths (1.4M deaths in 2021 - levels last seen in 2017). In addition, a reliance on sputum-based testing has limited case detection efforts, particularly among individuals with paucibacillary disease (e.g., people living with HIV \[PLHIV\] and children) and those investigated earlier in their TB disease progression, where sputum production is inherently difficult. New fit-for-purpose diagnostics are thus urgently needed to recover lost ground and to bring testing closer to patients and address current sampling limitations. The DriveDx4TB project 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. The project will independently evaluate three technology classes: 1. 3rd Generation urine LAM 2. Point-of-care (POC) MDx using tongue swabs 3. Near POC MDx using tongue swabs or sputum The data gathered from this study will support in-country decision-making for the uptake of new TB diagnostics, and will form part of evidence reviewed by the WHO for policy development or prequalification (PQ) processes.

Conditions

• Tuberculosis

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2023-08-31
• Last updated: 2025-06-24