Rapid Research in Diagnostics Development for TB Network
ConditionTuberculosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorUniversity of California, San Francisco
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
Qualifiers
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
Treatments tested in this trial
- Novel mycobacterial culture techniques
- Novel sputum smear microscopy techniques
- Sputum-based molecular assays
- Tongue swab-based molecular assays
- Urine LAM assays
- Blood-based host immune response assays
- Breath-based assays
- Artificial intelligence-based digital health tools
- Phage-based assays
- Cartridge-based molecular assays for detecting drug resistance
- Sequencing-based assays for detecting drug resistance
Treatment groups
26,436 Participants
are divided into 2 treatment groupsSponsors and collaborators
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
Source ClinicalTrials.gov