Rapid Research in Diagnostics Development for TB Network

NCT04923958 · tracked via the Priya Life Science India tracker

Sponsor

University of California, San Francisco

Phase

N/A

Started

2021-04-14

Last updated

2026-05-06

Condition(s) studied

Tuberculosis

Investigational drug(s) / intervention(s)

Novel mycobacterial culture techniquesNovel sputum smear microscopy techniquesSputum-based molecular assaysTongue swab-based molecular assaysUrine LAM assaysBlood-based host immune response assaysBreath-based assaysArtificial intelligence-based digital health toolsPhage-based assaysCartridge-based molecular assays for detecting drug resistanceSequencing-based assays for detecting drug resistance

Novel mycobacterial culture techniques: We will evaluate tests intended to make culture more sensitive, faster, and have less contamination.

Novel sputum smear microscopy techniques: We will evaluate new staining techniques or visualization methods to increase the sensitivity of smear microscopy.

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.

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.

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.

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.

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.

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).

Phage-based assays: We will evaluate assays using phages to lyse mycobacterial cells for detection of DNA or antigens.

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.

Sequencing-based assays for detecting drug resistance: We will evaluate targeted and whole genome sequencing assays.

Study 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.

Eligibility

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

Novel TB triage and diagnostic tests: We will include non-hospitalized adults (age ≥ 12 years) with either 1) cough ≥2 weeks' duration, a commonly accepted criterion for identifying people with presumed pulmonary TB (to facilitate standardization across sites and comparison of test performance across sub-groups or 2) risk factors for which TB screening is recommended (HIV infection, self-reported close contact, history of mining work). People with risk factors will be included if they screen positive for TB based on WHO-recommended screening tools as specified below: Positive TB screening definitions by risk factor: 1. PLHIV (Risk Factor), CRP \>5 mg/dL OR abnormal CXR (Positive TB screening definition) 2. Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition) 3. History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition) We will exclude people who: 1. completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively); 2. have taken any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason, within 2 weeks of study entry (to reduce false-negatives); 3. reside \>20km from the study site or are unwilling to return for follow-up visits; or 4. are unwilling to provide informed consent Novel TB rDST assays: We will include adults (age ≥12 years) who are positive for TB and RIF resistance according to routine diagnostic testing (based typically on Xpert MTB/RIF, Xpert MTB/RIF Ultra, or Hain MTBDRplus). We will exclude people who: 1. have negative or contaminated results on all baseline (i.e., enrollment) sputum cultures 2. are unable to provide at least two sputum specimens of 3 mL each within one day of enrollment 3. are unable or unwilling to provide informed consent Assessment of the usability of novel TB tests: We will include health workers at each clinical site who are 1) aged ≥18 years and 2) involved in routine TB testing (collecting specimens for or performing TB tests). We will exclude staff who are unwilling to provide informed consent.

Primary outcome measure(s)

Sensitivity — 7 months
Number of positive results for a given index test/(Total positive + negative results for a given index test) among patients with TB using the microbiological reference standard
Specificity — 7 months
Number of negative results for a given index test/(Total positive + negative results for a given index test) among patients without TB using the microbiological reference standard

Trial sites (16)

Facility	City	Region	Status
National Center for Tuberculosis and Lung Diseases	Tbilisi	Georgia	Recruiting
Chitoor (Christian Medical College satellite campus)	Vellore	India	Recruiting
Christian Medical College CMC Pulmonary Outpatient Department	Vellore	India	Recruiting
Primary care clinics (Shalom/LCC, CHAD)	Vellore	India	Recruiting
Zankli Research Center	Abuja	Nigeria	Recruiting
De La Salle Medical and Health Sciences Institute	Dasmariñas	Philippines	Recruiting
Brooklyn Chest Hospital	Cape Town	South Africa	Recruiting
Khayelitsha District Health Center	Cape Town	South Africa	Recruiting
Kraaifontein Community Health Clinic	Cape Town	South Africa	Recruiting
Scottsdene primary care clinic	Cape Town	South Africa	Recruiting
Wallacedene primary care clinic	Cape Town	South Africa	Recruiting
Kisenyi Health Center	Kampala	Uganda	Recruiting
Mulago Outpatient Department	Kampala	Uganda	Recruiting
Hanoi Lung Hospital, Outpatient departments	Hanoi	Vietnam	Recruiting
National Lung Hospital, Outpatient departments	Hanoi	Vietnam	Recruiting
Centre for Infectious Disease Research in Zambia	Lusaka	Zambia	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04923958 on ClinicalTrials.gov ↗ ← All trials in India