Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment

Launched by UNIVERSITY OF OXFORD · Feb 19, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new method to monitor tuberculosis (TB) treatment by looking at specific DNA from the bacteria that cause TB, called Mycobacterium tuberculosis. Researchers want to see if measuring these tiny pieces of DNA in the blood can give better insights into how well TB treatment is working compared to current methods, which can be slow and less reliable. The study will take place at the Mae RaMat TB Center in Thailand.

To participate in this trial, individuals must be at least 18 years old and have just been diagnosed with TB but have not started treatment yet. Healthy volunteers aged 18 and older who do not have a history of TB may also join. Participants will learn more about the study and what is required of them before giving their consent. This trial is not yet recruiting participants, so it's still in the planning phase. Overall, this research aims to improve how we monitor TB treatment, potentially leading to better patient outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants with a new diagnosis of tuberculosis
• • Aged ≥ 18 years old
• • Newly microbiologically confirmed (culture or nucleic acid amplification test) diagnosis of Mycobacterium tuberculosis (Mtb.) infection (of any site)
• • Has not yet commenced antituberculosis therapy
• • Able to understand study procedures and requirements and is able to give informed consent
• For healthy volunteers:
• • Aged ≥ 18 years old
• • Healthy as judged by a responsible physician
• • Able to understand study procedures and requirements and is able to give informed consent
• Exclusion Criteria:
• • Participants with a new diagnosis of tuberculosis
• • Exposure to antituberculosis treatment in the last 8 weeks (or Mycobacterium tuberculosis (Mtb.) active fluoroquinolone)
• • Known history of underlying malignancy
• • Pregnancy
• • Transfusion dependent anaemia
• For healthy volunteers:
• • History of tuberculosis infection or latent tuberculosis infection
• • Household, or other close contact, of a person living with tuberculosis disease
• • Chest radiograph (CXR) changes suggestive of pulmonary tuberculosis
• • Presence of symptoms which would otherwise indicate screening for tuberculosis (cough \> 2 weeks duration, fever, weight loss, night sweats)
• • Other major medical comorbidity
• • Pregnancy
• • Known malignancy