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Candidate Clinical Correlate of Prognostic Outcome for TB Study
Sponsor: University of California, San Francisco
Summary
As part of the ongoing efforts within the Rapid Research in Diagnostics Development for TB Network (R2D2 TB Network) study, the Candidate Clinical Correlate as Prognostic Outcome for TB (C3PO) study serves as a supplement aimed at evaluating predictors and novel biomarkers of recurrent TB among TB survivors. Current tools for predicting TB recurrence risk are suboptimal, limiting the ability to assess new TB treatment regimens effectively. Identifying accurate sputum- or blood-based biomarkers for recurrence risk could significantly improve the efficiency and informativeness of Phase 2 and 3 clinical trials.
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
750
Start Date
2025-11-25
Completion Date
2027-05
Last Updated
2026-01-23
Healthy Volunteers
No
Conditions
Interventions
RS ratio
We will evaluate the non-culture, sputum-based assay RS ratio, which measures ongoing Mycobacterium tuberculosis activity by quantifying the abundance of precursor rRNA relative to mature rRNA (an indicator of active rRNA synthesis).
Blood-based host immune response assays
We will evaluate blood-based assays measuring host immune response parameters for predicting mycobacterial activity.
Locations (3)
Kisenyi Health Center
Kampala, Uganda
Mulago Outpatient Department
Kampala, Uganda
Hanoi Lung Hospital, Outpatient departments
Hanoi, Vietnam