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NCT Number: NCT06845618

Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This study is funded by the Wellcome Trust; grant reference number: 223099/Z/21/Z

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mtb-cfDNA trajectories

    Time frame: Day 0 - 168 (or end of treatment)

    Rate of Mtb-cfDNA clearance derived from serial Mtb-cfDNA measurements

  2. Percentage of participants completing sampling schedule

    Time frame: Day 0 - 168 (or end of treatment)

Secondary outcomes

  1. Exploratory analysis is planned and will compare Mtb-cfDNA levels to clinical, microbiological and radiological features

    Time frame: Day 0 - 168 (or end of treatment)

Study contacts

Contact information is provided by the study sponsor or research team.

François Nosten, Professor

CONTACT

[email protected]

055 532026

Htet Ko Ko Aung, Dr

CONTACT

[email protected]

055 581 135 ext. 109

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

Mycobacterium Tuberculosis Complex Cell-free DNA (Mtb-cfDNA) for the Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study

Acronym: Mtb-Dynamic

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2025
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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