Actively Recruiting
Mycobacterium Tuberculosis Complex Cell-free DNA for Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study
Led by University of Oxford · Updated on 2026-04-13
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older with a new microbiologically confirmed diagnosis of Mycobacterium tuberculosis infection
- Participants must not have started antituberculosis therapy
- Able to understand study procedures and provide informed consent
- Healthy volunteers aged 18 years or older judged healthy by a physician
- Healthy volunteers able to understand study procedures and provide informed consent
You will not qualify if you...
- Participants with exposure to antituberculosis treatment or active fluoroquinolone use in the last 8 weeks
- Known history of underlying malignancy
- Pregnancy
- Transfusion dependent anaemia
- Healthy volunteers with history of tuberculosis infection or latent TB
- Healthy volunteers with close contact to someone with tuberculosis
- Healthy volunteers with chest X-ray changes suggesting pulmonary tuberculosis
- Healthy volunteers with symptoms suggestive of tuberculosis (cough > 2 weeks, fever, weight loss, night sweats)
- Healthy volunteers with major medical comorbidities
- Healthy volunteers who are pregnant
- Healthy volunteers with known malignancy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants with new tuberculosis diagnosis and healthy volunteers have blood collected to assess tuberculosis DNA levels.
1 visit (in-person)
Duration - Up to 24 weeks or until end of treatment
Participants with tuberculosis have longitudinal blood sampling from diagnosis through the end of treatment to monitor tuberculosis DNA levels and treatment response.
Multiple visits over approximately 24 weeks
Trial Site Locations
Total: 1 location
1
Shoklo Malaria Research Unit (SMRU)
Tak, Thailand
Actively Recruiting
Research Team
H
Htet Ko Ko Aung, Dr
F
François Nosten, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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