Actively Recruiting

Phase Not Applicable
Age: 12Years +
All Genders
NCT04923958

Rapid Research in Diagnostics Development for TB Network

Led by University of California, San Francisco · Updated on 2026-05-06

26436

Participants Needed

16

Research Sites

528 weeks

Total Duration

On this page

Sponsors

U

University of California, San Francisco

Lead Sponsor

U

University Hospital Heidelberg

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Rapid Research in Diagnostics Development for TB Network

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Non-hospitalized adults aged 12 years or older
  • Cough lasting 2 weeks or more, or
  • Presence of TB risk factors (HIV infection, self-reported close contact with TB, or history of mining work) with positive TB screening based on WHO-recommended tools
  • Adults aged 12 years or older with confirmed TB and rifampin resistance for drug resistance testing
  • Health workers aged 18 years or older involved in routine TB testing at clinical sites for usability assessment
Not Eligible

You will not qualify if you...

  • Completed latent or active TB treatment within the past 12 months
  • Taken any anti-mycobacterial medication, including fluoroquinolones, within 2 weeks before study entry
  • Living more than 20 km from the study site or unwilling to attend follow-up visits
  • Unwilling to provide informed consent
  • Negative or contaminated baseline sputum cultures for drug resistance testing
  • Unable to provide at least two sputum samples of 3 mL each within one day of enrollment
  • Health workers unwilling to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

National Center for Tuberculosis and Lung Diseases

Tbilisi, Georgia

Actively Recruiting

2

Chitoor (Christian Medical College satellite campus)

Vellore, India

Actively Recruiting

3

Christian Medical College CMC Pulmonary Outpatient Department

Vellore, India

Actively Recruiting

4

Primary care clinics (Shalom/LCC, CHAD)

Vellore, India

Actively Recruiting

5

Zankli Research Center

Abuja, Nigeria

Actively Recruiting

6

De La Salle Medical and Health Sciences Institute

Dasmariñas, Philippines

Actively Recruiting

7

Brooklyn Chest Hospital

Cape Town, South Africa

Actively Recruiting

8

Khayelitsha District Health Center

Cape Town, South Africa

Actively Recruiting

9

Kraaifontein Community Health Clinic

Cape Town, South Africa

Actively Recruiting

10

Scottsdene primary care clinic

Cape Town, South Africa

Actively Recruiting

11

Wallacedene primary care clinic

Cape Town, South Africa

Actively Recruiting

12

Kisenyi Health Center

Kampala, Uganda

Actively Recruiting

13

Mulago Outpatient Department

Kampala, Uganda

Actively Recruiting

14

Hanoi Lung Hospital, Outpatient departments

Hanoi, Vietnam

Actively Recruiting

15

National Lung Hospital, Outpatient departments

Hanoi, Vietnam

Actively Recruiting

16

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

Actively Recruiting

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Research Team

A

Adithya Cattamanchi, MD

CONTACT

C

Catherine Cook, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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