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RECRUITINGOBSERVATIONAL

Candidate Clinical Correlate of Prognostic Outcome for TB Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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). Who Should NOT Join This Trial: 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 willing to sign a consent form or return for study follow-up visits. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIAGNOSTIC_TEST

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).

DIAGNOSTIC_TEST

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