NCT06845618Recruiting
Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment
Mycobacterium Tuberculosis Complex Cell-free DNA (Mtb-cfDNA) for the Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
Tuberculosis (TB) is a leading infectious cause of death worldwide. Current strategies for monitoring TB treatment response are culture dependent and insensitive. New methods of assessing treatment response in vivo could inform new drug development and other treatment strategies. Cell-free DNA (cfDNA) - small circulating fragments of DNA - is widely used in maternofetal medicine and oncology for diagnosis and assessment of treatment response. This study aims to investigate whether pathogen derived Mycobacterium tuberculosis-specific cfDNA (Mtb-cfDNA) can be used to monitor TB treatment response. This feasibility study will take place at Mae RaMat TB Center in Thailand and includes two study groups: 1. Assay Development and Validation 2. Longitudinal Assessment of Mtb-cfDNA levels
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 140 (estimated)
- First submitted
- 19 Feb 2025
- Start date
- 21 Jul 2025
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- University of Oxford
- Diseases
- Tuberculosis
- NCT number
- NCT06845618
What you commit to
- Study type: Observational
- Planned participants: 140
- From 21 Jul 2025 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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)
- Known malignancy
Other
- Pregnancy
- Transfusion dependent anaemia
- For healthy volunteers:
- Other major medical comorbidity
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shoklo Malaria Research Unit (SMRU) Coordinator of this site? Confirm its status | Tak | Thailand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.