About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
PLHIV (Risk Factor), CRP >5 mg/dL OR abnormal CXR (Positive TB screening definition)
Self-reported Close Contact (Risk Factor), abnormal CXR (Positive TB screening definition)
History of mining work (Risk Factor), abnormal CXR (Positive TB screening definition)
completed latent or active TB treatment within the past 12 months (to increase TB prevalence and reduce false-positive results, respectively);
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Novel mycobacterial culture techniques
Diagnostic testWe will evaluate tests intended to make culture more sensitive, faster, and have less contamination.
Novel sputum smear microscopy techniques
Diagnostic testWe will evaluate new staining techniques or visualization methods to increase the sensitivity of smear microscopy.
Sputum-based molecular assays
Diagnostic testWe 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
Diagnostic testWe will evaluate semi-automated or automated molecular assays intended for use at near point of care or point of care.
Urine LAM assays
Diagnostic testWe 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
Diagnostic testWe will evaluate assays measuring host immune response parameters intended for use at near point of care or point of care.
Breath-based assays
Diagnostic testWe 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
Diagnostic testWe 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
Diagnostic testWe will evaluate assays using phages to lyse mycobacterial cells for detection of DNA or antigens.
Cartridge-based molecular assays for detecting drug resistance
Diagnostic testWe 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
Diagnostic testWe will evaluate targeted and whole genome sequencing assays.
Treatment groups
Trial outcomes
Primary outcomes
Sensitivity
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
University Hospital Heidelberg
Collaborator
Christian Medical College, Vellore, India
Collaborator
Vietnam National Lung Hospital
Collaborator
De La Salle University Medical Center
Collaborator
University of Stellenbosch
Collaborator
Makerere University
Collaborator
Johns Hopkins Bloomberg School of Public Health
Collaborator
Harvard Medical School (HMS and HSDM)
Collaborator
Stanford University
Collaborator
Foundation for Innovative New Diagnostics, Switzerland
Collaborator
Socios En Salud Sucursal, Peru
Collaborator
Federal University of Mato Grosso
Collaborator
Medical Research Council
Collaborator
National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia
Collaborator
Centre for Infectious Disease Research in Zambia
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Zankli Research Center
Collaborator
University of California, Irvine
Collaborator
Johns Hopkins University
Collaborator