Candidate Clinical Correlate of Prognostic Outcome for TB Study
University of California, San Francisco
750 participants
Nov 25, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- . individuals age ≥ 12 years;
- . have completed treatment for drug-susceptible tuberculosis with the standard 6-month regimen of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE).
Exclusion Criteria3
- completed treatment for drug-susceptible tuberculosis >14 days prior to screening/enrollment;
- routinely taking any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason not related to tuberculosis treatment within the last 14 days;
- unwilling to provide informed consent or return for study follow-up visits.
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Interventions
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).
We will evaluate blood-based assays measuring host immune response parameters for predicting mycobacterial activity.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07018076