An observational study in Tuberculosis, sponsored by Foundation for Innovative New Diagnostics, Switzerland. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Foundation for Innovative New Diagnostics, Switzerland · Observational
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.
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:
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.
1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.
This study's planned enrollment of 1,890 is above the median of 253 across 317 observational studies indexed under Tuberculosis.
Browse Tuberculosis studies →Foundation for Innovative New Diagnostics, Switzerland is the lead sponsor of 61 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: 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.
Time frame: 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.
Time frame: February 2024 to August 2025
2.1
Comparison of the diagnostic accuracy between index tests and a comparator test or combinations belonging to the same technology class (POC, near POC MDx or low complexity NAAT), for TB detection among adults with presumptive pulmonary TB. Difference between the point estimates (with 95% confidence intervals) of sensitivity and specificity for each index test and its relative comparator test, using 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.
Time frame: February 2024 to August 2025
2.2
Determination of the diagnostic accuracy of POC index tests using urine samples, of near POC MDx index tests using tongues swabs, and of near POC MDx index tests using tongue swabs or sputum for TB detection among adults with presumptive pulmonary TB and HIV infection using MRS, eMRS and CRS. Point estimates (with 95% confidence intervals) of sensitivity, specificity, balanced accuracy, DOR, PPV and NPV for POC index tests using urine samples, near POC MDx index tests using tongues swabs, and low complexity NAAT index tests using tongue swabs or sputum, in the TB and HIV co-infection subgroup using MRS, eMRS and CRS as reference standards.
Time frame: February 2024 to August 2025
2.3
Evaluation of the usability of POC, of near POC MDx and of low complexity NAAT index tests in a real-world setting. Usability of each index test (3rd generation LAM, near POC MDx and low complexity NAAT) measured by the operators' ability to understand the test instructions, workflow and results interpretation.
Time frame: February 2024 to August 2025
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This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Foundation for Innovative New Diagnostics, Switzerland