Monitoring Tuberculosis Treatment Using Blood Tuberculosis DNA Levels A Study on Mycobacterium Tuberculosis Cell-free DNA to Track Treatment Response

What this Trial Is About

Tuberculosis TB is a leading infectious cause of death worldwide, and current methods to monitor TB treatment rely on culture tests that can be slow and less sensitive. Researchers are investigating whether small fragments of DNA from the TB bacteria, called Mycobacterium tuberculosis-specific cell-free DNA Mtb-cfDNA, found in the blood can be used to track how well treatment is working. This observational study is a proof-of-concept funded by the Wellcome Trust and led by the University of Oxford. The study includes two groups one to develop and validate the test for detecting Mtb-cfDNA, and another to follow TB patients over time to see how the levels of Mtb-cfDNA change during treatment. The first group involves 20 participants with newly diagnosed TB and 20 healthy volunteers without TB, with blood samples collected at the start. The second group consists of 120 TB patients who will have blood samples taken repeatedly from diagnosis until the end of treatment to assess the dynamics of Mtb-cfDNA levels. Participants will have blood collected for analysis of Mtb-cfDNA from day 0 up to 168 days or until treatment completion. Researchers will monitor how many participants complete the sampling schedule and explore relationships between Mtb-cfDNA levels and clinical, microbiological, and radiological features. The study aims to establish whether this blood test could become a useful tool to assess TB treatment response over time.

Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment