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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)
Foundation for Innovative New Diagnostics, Switzerland·ClinicalTrials.govNot yet recruiting
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Study focus
Disease/Condition
Tuberculosis
Study type
Observational
Sponsor & location
Primary sponsor
Foundation for Innovative New Diagnostics, Switzerland
Timeline & enrollment
Phase
N/A
Start date
Feb 01, 2024
End date
Nov 01, 2025
Enrollment
1890 participants
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
TuberculosisLatent tuberculosisTuberculosis of other organsCongenital tuberculosisSequelae of tuberculosis
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06019052
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.