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

NCT06019052 | Not Yet Recruiting

• 1 other identifier: TB051
• Study Type: observational
• Target: 1,890
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Tuberculosis

Keywords

TB; Diagnostics; HIV; Diagnostic accuracy study; Alternative samples; Point of care (POC); Near POC; Molecular diagnostic (MDx) platforms; Urine LAM

Outcome Measures

Primary Outcomes (3)

• 1.1

  Determination of the diagnostic accuracy of POC index tests using urine samples for TB detection among adults with presumptive pulmonary TB using as reference standards MRS, eMRS, and CRS. Point estimates (with 95% confidence intervals) of sensitivity, specificity, balanced accuracy, diagnostic odds ratio (DOR), positive and negative predictive values (PPV and NPV) for POC index tests using the defined MRS, eMRS and CRS as reference standards. Point estimates of sensitivity and specificity will be calculated based on the definitions reported in protocol, with 95% confidence intervals calculated using Wilson's score method. The efficacy analyses will be performed on the PP population. Additional subgroup analyses of the primary endpoints will be performed as per SAP.

  February 2024 to August 2025

• 1.2

  Determination of the diagnostic accuracy of near POC MDx index tests using tongue swabs for TB detection among adults with presumptive pulmonary TB using as reference standards MRS, eMRS and CRS. Point estimates (with 95% confidence intervals) of sensitivity, specificity, balanced accuracy, DOR, PPV and NPV for near POC MDx index tests, using the defined MRS, eMRS and CRS as reference standards. Point estimates of sensitivity and specificity will be calculated based on the definitions reported in protocol with 95% confidence intervals calculated using Wilson's score method. The efficacy analyses will be performed on the PP population. Additional subgroup analyses of the primary endpoints will be performed as per SAP.

  February 2024 to August 2025

• 1.3

  Determination of the diagnostic accuracy of low complexity NAAT index tests using tongue swabs or sputum for TB detection among adults with presumptive pulmonary TB using as reference standards MRS, eMRS and CRS.Point estimates (with 95% confidence intervals) of sensitivity, specificity, balanced accuracy, DOR, PPV and NPV for low complexity index tests, using the defined MRS, eMRS and CRS as reference standards.Point estimates of sensitivity and specificity will be calculated based on the definitions reported in protocol with 95% confidence intervals calculated using Wilson's score method. The efficacy analyses will be performed on the PP population. Additional subgroup analyses of the primary endpoints will be performed as per SAP.

  February 2024 to August 2025

Secondary Outcomes (3)

• 2.1

  February 2024 to August 2025

• 2.2

  February 2024 to August 2025

• 2.3

  February 2024 to August 2025

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 1800 Adult (≥18 years), with presumptive pulmonary TB i.e., self-reporting cough ≥2 weeks and ≥1 other symptom typical of pulmonary TB\* will be enrolled in the study.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation for Innovative New Diagnostics, Switzerland: lead

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Pamela Nabeta, Medical Doctor

CONTACT

+41 22 710 27 87; pamela.nabeta@finddx.org

Charu Paliwal, Master in Biotechnology

CONTACT

09560003368; charu.paliwal@finddx.org

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 31, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share