Rapid Research in Diagnostics Development for TB Network

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.

Conditions

• Tuberculosis

Interventions

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.

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).

Sponsors & Collaborators

• University Hospital Heidelberg

  collaborator OTHER

• Christian Medical College, Vellore, India

  collaborator OTHER

• Vietnam National Lung Hospital

  collaborator UNKNOWN

• De La Salle University Medical Center

  collaborator OTHER

• University of Stellenbosch

  collaborator OTHER

• Makerere University

  collaborator OTHER

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• Harvard Medical School (HMS and HSDM)

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Foundation for Innovative New Diagnostics, Switzerland

  collaborator OTHER

• Socios En Salud Sucursal, Peru

  collaborator OTHER

• Federal University of Mato Grosso

  collaborator OTHER

• Medical Research Council

  collaborator OTHER_GOV

• National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

  collaborator OTHER

• Centre for Infectious Disease Research in Zambia

  collaborator OTHER

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Zankli Research Center

  collaborator UNKNOWN

• University of California, Irvine

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Adithya Cattamanchi, MD · University of California, San Francisco

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-14

Primary Completion

2031-05-31

Completion

2031-05-31

FDA Device

Yes

Countries

• Georgia
• India
• Nigeria
• Philippines
• South Africa
• Uganda
• Vietnam
• Zambia

Study Locations