NCT04923958

Rapid Research in Diagnostics Development for TB Network

Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 26,436 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To reduce the burden of TB worldwide through more accurate, faster, simpler, and less expensive diagnosis of TB Every year, more than 3 million people with TB remain undiagnosed and 1 million die. Better diagnostics are essential to reducing the enormous burden of TB worldwide. The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) brings together experts in TB care, technology assessment, diagnostics development, laboratory medicine, epidemiology, health economics and mathematical modeling with highly experienced clinical study sites in 10 countries.

Detailed description

The Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) study seeks to identify and rigorously assess promising early stage tuberculosis (TB) triage, diagnostic and drug resistance tests (hereafter referred to as "novel tests") in clinical studies conducted in settings of intended use. Rapid diagnosis, identification of drug resistance and effective treatment are critical for improving patient outcomes and reducing TB transmission. However, analysis of care cascades and prevalence surveys indicate that 40-60% of patients with TB are not initiated on effective treatment.1,2 The different types of tests required to reduce this "diagnostic gap" have been described in the form of target product profiles (TPPs). The highest- priority TPPs are for: 1) a point-of-care, non-sputum biomarker-based test to facilitate rapid TB diagnosis using easily accessible samples (a biomarker-based diagnostic test) and 2) a simple, low-cost test that can be used by front-line health workers to rule-out TB (a triage test). The R2D2 TB Network study will evaluate the sensitivity and specificity of novel triage and diagnostic tests against a reference standard including sputum Xpert® MTB/RIF (Mycobacterium tuberculosis/Rifampin) Ultra and sputum mycobacterial culture. The sensitivity and specificity of rapid drug susceptibility tests (rDST) will be compared against a reference standard including culture-based phenotypic DST and whole genome sequencing (WGS) of mycobacterial DNA. In addition, the usability of novel tests will be assessed through direct observations and surveys of routine health workers.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Novel mycobacterial culture techniques	We will evaluate tests intended to make culture more sensitive, faster, and have less contamination.
DIAGNOSTIC_TEST	Novel sputum smear microscopy techniques	We will evaluate new staining techniques or visualization methods to increase the sensitivity of smear microscopy.
DIAGNOSTIC_TEST	Sputum-based molecular assays	We will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.
DIAGNOSTIC_TEST	Tongue swab-based molecular assays	We will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.
DIAGNOSTIC_TEST	Urine LAM assays	We will evaluate urine LAM assays incorporating techniques such as analyte concentration, higher sensitivity or specificity antibodies, or enhanced visualization to improve LAM detection.
DIAGNOSTIC_TEST	Blood-based host immune response assays	We will evaluate assays measuring host immune response parameters intended for use at near point of care or point of care.
DIAGNOSTIC_TEST	Breath-based assays	We will evaluate assays assessing volatile organic compounds or exhaled breath condensate for near point of care of point of care detection of TB.
DIAGNOSTIC_TEST	Artificial intelligence-based digital health tools	We will evaluate AI-based algorithms evaluating images (chest x-ray, ultrasound) or sounds (cough sounds, lung sounds) including an Infrasound-to-ultrasound e-stethoscope (Level 42 AI, USA).
DIAGNOSTIC_TEST	Phage-based assays	We will evaluate assays using phages to lyse mycobacterial cells for detection of DNA or antigens.
DIAGNOSTIC_TEST	Cartridge-based molecular assays for detecting drug resistance	We will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.
DIAGNOSTIC_TEST	Sequencing-based assays for detecting drug resistance	We will evaluate targeted and whole genome sequencing assays.

Timeline

• Start date: 2021-04-14
• Primary completion: 2031-05-31
• Completion: 2031-05-31
• First posted: 2021-06-11
• Last updated: 2025-11-14

Locations

16 sites across 8 countries: Georgia, India, Nigeria, Philippines, South Africa, Uganda, Vietnam, Zambia

Regulatory

• FDA-regulated device study