NCT04923958: R2D2TB Network

Rapid Research in Diagnostics Development for TB Network

Recruiting now NA Last updated 14 November 2025

What this trial tests

NA trial testing Novel mycobacterial culture techniques in Tuberculosis in 26,436 participants. Currently enrolling.

Timeline

14 April 2021

Primary endpoint
31 May 2031

31 May 2031

Quick facts

Lead sponsor	University of California, San Francisco
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	26,436
Start date	14 April 2021
Primary completion	31 May 2031
Estimated completion	31 May 2031
Sites	16 locations across Georgia, South Africa, Vietnam, Zambia, Nigeria, Philippines, Uganda, India

Drugs / interventions tested

• Novel mycobacterial culture techniques
• Novel sputum smear microscopy techniques
• Sputum-based molecular assays
• Tongue swab-based molecular assays
• Urine LAM assays
• Blood-based host immune response assays
• Breath-based assays
• Artificial intelligence-based digital health tools
• Phage-based assays
• Cartridge-based molecular assays for detecting drug resistance
• Sequencing-based assays for detecting drug resistance

Conditions studied

• Tuberculosis — all drugs for Tuberculosis →

Sponsor

University of California, San Francisco

Who can join

12 and older, any sex, with Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluation of the Xpert MTB Host Response assay for the triage of patients with presumed pulmonary tuberculosis: a prospective diagnostic accuracy study in Viet Nam, India, the Philippines, Uganda, and South Africa.
   Gupta-Wright A, Ha H, Abdulgadar S, Crowder R, et al · · 2024 · cited 36× · PMID 38245113 · DOI 10.1016/s2214-109x(23)00541-7
2. Diagnostic Accuracy of Tuberculosis Screening Tests in a Prospective Multinational Cohort: Chest Radiography With Computer-Aided Detection, Xpert Tuberculosis Host Response, and C-Reactive Protein.
   Crowder R, Thangakunam B, Andama A, Christopher DJ, et al · · 2026 · cited 16× · PMID 39509711 · DOI 10.1093/cid/ciae549
3. Diagnostic accuracy of swab-based molecular tests for tuberculosis using near-point-of-care platforms: a multi-country evaluation.
   Steadman A, Kumar KM, Asege L, Kato-Maeda M, et al · · 2025 · cited 10× · PMID 41175672 · DOI 10.1016/j.ebiom.2025.105991
4. Sputum scarcity and associated factors in people undergoing tuberculosis testing in South Africa, Uganda, India, and the Philippines: an analysis of cross-sectional observational data.
   Nwamba WV, Okunola AO, Crowder R, Christopher DJ, et al · · 2026 · PMID 42180402 · DOI 10.1016/j.eclinm.2026.103977
5. Pulmonary Tuberculosis Detection with MiniDock MTB Using Swab Samples.
   Yerlikaya S, Chirwa M, Ajide B, Castro MDM, et al · · 2026 · PMID 42054680 · DOI 10.1056/nejmoa2509761
6. Head-to-head comparison of diagnostic accuracy of TB screening tests: Chest-X-ray, Xpert TB host response, and C-reactive protein
   Crowder R, Thangakunam B, Andama A, Christopher DJ, et al · · 2024 · DOI 10.1101/2024.06.20.24308402