Candidate Clinical Correlate of Prognostic Outcome for TB Study
ConditionTuberculosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorUniversity of California, San Francisco
About this trial
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
Qualifiers
. individuals age ≥ 12 years;
. have completed treatment for drug-susceptible tuberculosis with the standard 6-month regimen of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- RS ratio
- Blood-based host immune response assays
Treatment groups
No treatment groups listed
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
University of California, Irvine
Collaborator
University of Colorado, Denver
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov