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Candidate Clinical Correlate of Prognostic Outcome for TB Study

NCT07018076 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 750

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of California, Irvine

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • University of California, San Francisco

    lead OTHER

Principal Investigators

  • Adithya Cattamanchi, MD · University of California San Francisco; University of California Irvine

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Device
Yes

Countries

  • Uganda
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07018076 on ClinicalTrials.gov