Rapid Research in Diagnostics Development for TB Network
NCT ID: NCT04923958
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
26436 participants
INTERVENTIONAL
2021-04-14
2031-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Evaluation of various novel TB triage and diagnostic tests.
For the novel TB triage and diagnostic tests, the investigators will conduct large-scale evaluation of design-locked tests in a cohort of adults with presumed TB, with nested feasibility/pilot studies of early and late prototype tests. The investigators aim to enroll 300-450 participants per year at each of five enrollment sites for evaluation of various novel TB triage and diagnostic tests and 50 health workers to assess test usability.
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.
Evaluation of novel rDST assays
Clinicians at participating sites will be asked to refer adult patients with rifampin-resistance identified by routine molecular testing. The investigators aim to enroll 100-200 patients per year at each of three enrollment sites for evaluation of novel rDST assays.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
12 Years
ALL
No
Sponsors
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Makerere University
OTHER
Johns Hopkins Bloomberg School of Public Health
OTHER
University Hospital Heidelberg
OTHER
Christian Medical College, Vellore, India
OTHER
Vietnam National Lung Hospital
UNKNOWN
De La Salle University Medical Center
OTHER
University of Stellenbosch
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
Stanford University
OTHER
Foundation for Innovative New Diagnostics, Switzerland
OTHER
Socios En Salud Sucursal, Peru
OTHER
Federal University of Mato Grosso
OTHER
Medical Research Council
OTHER_GOV
National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
OTHER
Centre for Infectious Disease Research in Zambia
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Zankli Research Center
UNKNOWN
University of California, Irvine
OTHER
Johns Hopkins University
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Adithya Cattamanchi, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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National Center for Tuberculosis and Lung Diseases
Tbilisi, , Georgia
Chitoor (Christian Medical College satellite campus)
Vellore, , India
Christian Medical College CMC Pulmonary Outpatient Department
Vellore, , India
Primary care clinics (Shalom/LCC, CHAD)
Vellore, , India
Zankli Research Center
Abuja, , Nigeria
De La Salle Medical and Health Sciences Institute
Dasmariñas, , Philippines
Brooklyn Chest Hospital
Cape Town, , South Africa
Khayelitsha District Health Center
Cape Town, , South Africa
Kraaifontein Community Health Clinic
Cape Town, , South Africa
Scottsdene primary care clinic
Cape Town, , South Africa
Wallacedene primary care clinic
Cape Town, , South Africa
Kisenyi Health Center
Kampala, , Uganda
Mulago Outpatient Department
Kampala, , Uganda
Hanoi Lung Hospital, Outpatient departments
Hanoi, , Vietnam
National Lung Hospital, Outpatient departments
Hanoi, , Vietnam
Centre for Infectious Disease Research in Zambia
Lusaka, , Zambia
Countries
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Central Contacts
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Facility Contacts
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Nestani Tukvadze
Role: primary
DJ Christopher
Role: primary
DJ Christopher
Role: primary
DJ Christopher
Role: primary
John Bimba, MD
Role: primary
Charles Yu
Role: primary
Grant Theron
Role: primary
Grant Theron
Role: primary
Grant Theron
Role: primary
Grant Theron
Role: primary
Grant Theron
Role: primary
William Worodria
Role: primary
William Worodria
Role: primary
Nhung Nguyen
Role: primary
Nhung Nguyen
Role: primary
Monde Muyoyeta, Bsc, MBChB, PhD
Role: primary
References
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Crowder R, Thangakunam B, Andama A, Christopher DJ, Dalay V, Nwamba W, Kik SV, Van Nguyen D, Nhung NV, Phillips PPJ, Ruhwald M, Theron G, Worodria W, Yu C, Nahid P, Cattamanchi A, Gupta-Wright A, Denkinger CM. Diagnostic accuracy of TB screening tests in a prospective multinational cohort: Chest-X-ray with computer-aided detection, Xpert TB host response, and C-reactive protein. Clin Infect Dis. 2024 Nov 7:ciae549. doi: 10.1093/cid/ciae549. Online ahead of print.
Crowder R, Thangakunam B, Andama A, Christopher DJ, Dalay V, Dube-Nwamba W, Kik SV, Nguyen DV, Nhung NV, Phillips PP, Ruhwald M, Theron G, Worodria W, Yu C, Nahid P, Cattamanchi A, Gupta-Wright A, Denkinger CM; R2D2 TB Network. Head-to-head comparison of diagnostic accuracy of TB screening tests: Chest-X-ray, Xpert TB host response, and C-reactive protein. medRxiv [Preprint]. 2024 Jun 21:2024.06.20.24308402. doi: 10.1101/2024.06.20.24308402.
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Other Identifiers
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