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 - Trial NCT06019052
Access comprehensive clinical trial information for NCT06019052 through Pure Global AI's free database. This phase not specified trial is sponsored by Foundation for Innovative New Diagnostics, Switzerland and is currently Not yet recruiting. The study focuses on Tuberculosis. Target enrollment is 1890 participants.
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Study Focus
Observational
Sponsor & Location
Foundation for Innovative New Diagnostics, Switzerland
Timeline & Enrollment
N/A
Feb 01, 2024
Nov 01, 2025
Primary Outcome
1.1,1.2,1.3
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06019052
Non-Device Trial