NCT07018076 Candidate Clinical Correlate of Prognostic Outcome for TB Study
| NCT ID | NCT07018076 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Tuberculosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2027-05 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria: 1. . individuals age ≥ 12 years; 2. . have completed treatment for drug-susceptible tuberculosis with the standard 6-month regimen of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE). Exclusion Criteria: 1. completed treatment for drug-susceptible tuberculosis \>14 days prior to screening/enrollment; 2. routinely taking any medication with anti-mycobacterial activity (including fluoroquinolones) for any reason not related to tuberculosis treatment within the last 14 days; 3. unwilling to provide informed consent or return for study follow-up visits.