Blood TB DNA test to track treatment progress

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational feasibility project at the Mae RaMat TB Center (Shoklo Malaria Research Unit, Tak, Thailand) will measure Mycobacterium tuberculosis-derived cell-free DNA (Mtb-cfDNA) in blood samples. The work includes an assay development and validation arm plus a longitudinal cohort of adults with newly microbiologically confirmed TB sampled before and during standard therapy, with healthy adult controls. Mtb-cfDNA levels will be compared over time with conventional culture or nucleic acid test results to see if changes correlate with treatment response. The study is funded by the Wellcome Trust and aims to determine whether a blood-based cfDNA biomarker could be a practical tool for monitoring TB treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Shoklo Malaria Research Unit (SMRU)
  Tak, Thailand Recruiting

Study contacts

• Principal investigator: Timothy Seers, Dr — Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University.
• Study coordinator: Htet Ko Ko Aung, Dr
• Email: htetkoko@shoklo-unit.com
• Phone: 055 581 135

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.