Rapid Research in Diagnostics Development for TB Network

NARecruitingINTERVENTIONAL
Enrollment

26,436

Participants

Timeline

Start Date

April 14, 2021

Primary Completion Date

May 31, 2031

Study Completion Date

December 31, 2031

Conditions
Tuberculosis
Interventions
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.

Trial Locations (16)

Unknown

RECRUITING

National Center for Tuberculosis and Lung Diseases, Tbilisi

RECRUITING

Chitoor (Christian Medical College satellite campus), Vellore

RECRUITING

Christian Medical College CMC Pulmonary Outpatient Department, Vellore

RECRUITING

Primary care clinics (Shalom/LCC, CHAD), Vellore

RECRUITING

Zankli Research Center, Abuja

RECRUITING

De La Salle Medical and Health Sciences Institute, Dasmariñas

RECRUITING

Brooklyn Chest Hospital, Cape Town

RECRUITING

Khayelitsha District Health Center, Cape Town

RECRUITING

Kraaifontein Community Health Clinic, Cape Town

RECRUITING

Scottsdene primary care clinic, Cape Town

RECRUITING

Wallacedene primary care clinic, Cape Town

RECRUITING

Kisenyi Health Center, Kampala

RECRUITING

Mulago Outpatient Department, Kampala

RECRUITING

Hanoi Lung Hospital, Outpatient departments, Hanoi

RECRUITING

National Lung Hospital, Outpatient departments, Hanoi

RECRUITING

Centre for Infectious Disease Research in Zambia, Lusaka

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University Hospital Heidelberg

OTHER

collaborator

Christian Medical College, Vellore, India

OTHER

collaborator

Vietnam National Lung Hospital

UNKNOWN

collaborator

De La Salle University Medical Center

OTHER

collaborator

University of Stellenbosch

OTHER

collaborator

Makerere University

OTHER

collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

collaborator

Harvard Medical School (HMS and HSDM)

OTHER

collaborator

Stanford University

OTHER

collaborator

Foundation for Innovative New Diagnostics, Switzerland

OTHER

collaborator

Socios En Salud Sucursal, Peru

OTHER

collaborator

Federal University of Mato Grosso

OTHER

collaborator

Medical Research Council

OTHER_GOV

collaborator

National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

OTHER

collaborator

Centre for Infectious Disease Research in Zambia

OTHER

collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

Zankli Research Center

UNKNOWN

collaborator

University of California, Irvine

OTHER

collaborator

Johns Hopkins University

OTHER

lead

University of California, San Francisco

OTHER

NCT04923958 - Rapid Research in Diagnostics Development for TB Network | Biotech Hunter | Biotech Hunter