Mycobacterium TuberculosisMtb-DynamicNCT06845618
Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment
An observational study of Mycobacterium Tuberculosis and Tuberculosis, Pulmonary, run by University of Oxford at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mycobacterium Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Extra-Pulmonary
- How many people
- 140 participants
- Where
- 1 siteThailand
- Study dates
- 21 Jul 2025to 30 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Group 1: Assay development and validation. In this group, sampling will be performed at tuberculosis diagnosis. Tuberculosis participants (n = 20) will have blood sampling performed at day 0. Healthy participants (n = 20) without clinical evidence of tuberculosis will have blood sampling performed at a single timepoint. Group 2: Longitudinal Assessment. In this group, tuberculosis participants (n= 120) will have longitudinal sampling performed from diagnosis to the end of treatment. This will help to establish the feasibility of dynamic Mtb-cfDNA measurements.
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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:
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Shoklo Malaria Research Unit (SMRU)
Tak
Htet Ko Ko Aung, Dr, 055 581 135 ext. 109, htetkoko@shoklo-unit.com
François Nosten, Professor, 055 532026, francois@tropmedres.ac
About this study
Official title: Mycobacterium Tuberculosis Complex Cell-free DNA (Mtb-cfDNA) for the Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study
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:
- Assay Development and Validation
- Longitudinal Assessment of Mtb-cfDNA levels
Read the detailed description
This study is funded by the Wellcome Trust; grant reference number: 223099/Z/21/Z
- Keywords
- cfDNA
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis, Extrapulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Assay development and validation | Twenty participants with a new diagnosis of tuberculosis will have venous blood collected prior to treatment initiation. Twenty participants without clinical evidence of tuberculosis infection will be recruited from the local community as a control during assay validation. This group of the study participants will be assessed at day zero only. | |
| Group 2: Longitudinal Assessment | In this group, tuberculosis participants (n= 120) will have longitudinal sampling performed from diagnosis to the end of treatment. This will establish the feasibility of dynamic Mtb-cfDNA measurements for the assessment of tuberculosis treatment response. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mtb-cfDNA trajectories
Rate of Mtb-cfDNA clearance derived from serial Mtb-cfDNA measurements
Measured: Day 0 - 168 (or end of treatment)
Percentage of participants completing sampling schedule
Measured: 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
Measured: Day 0 - 168 (or end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start21 Jul 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycobacterium TuberculosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Seers, Dr, Principal investigator, Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845618
- Sponsor's protocol ID
- MYC24003
- Acronym
- Mtb-Dynamic
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data generated in this study belongs to the study group as a whole. The final database will be shared amongst the PI and key members of the research team. With participant's consent, clinical data and results from blood analyses stored in the database may be shared with researchers not directly involved in this study but only after the main paper has been published and in accordance with MORU guidelines on data sharing. The results of the study will be summarised in lay language, in both English and the language(s) commonly spoken at the study site, and disseminated to participants and the community. The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authorship will be determined in accordance with the International Committee of Medical Journal Editors (ICMJE) guidelines and other contributors will be acknowledged.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mycobacterium Tuberculosis Complex Cell-free DNA (Mtb-cfDNA) for the Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT06845618
- Acronym / sponsor ID
- Mtb-Dynamic / MYC24003
- Keywords
- cfDNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assay Development and Validation
- Longitudinal Assessment of Mtb-cfDNA levels
Detailed description
This study is funded by the Wellcome Trust; grant reference number: 223099/Z/21/Z
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Assay development and validation | – | –Twenty participants with a new diagnosis of tuberculosis will have venous blood collected prior to treatment initiation. Twenty participants without clinical evidence of tuberculosis infection will be recruited from the local community as a control during assay validation. This group of the study participants will be assessed at day zero only. |
| Group 2: Longitudinal Assessment | – | –In this group, tuberculosis participants (n= 120) will have longitudinal sampling performed from diagnosis to the end of treatment. This will establish the feasibility of dynamic Mtb-cfDNA measurements for the assessment of tuberculosis treatment response. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Assay development and validation. In this group, sampling will be performed at tuberculosis diagnosis. Tuberculosis participants (n = 20) will have blood sampling performed at day 0. Healthy participants (n = 20) without clinical evidence of tuberculosis will have blood sampling performed at a single timepoint. Group 2: Longitudinal Assessment. In this group, tuberculosis participants (n= 120) will have longitudinal sampling performed from diagnosis to the end of treatment. This will help to establish the feasibility of dynamic Mtb-cfDNA measurements.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mtb-cfDNA trajectories
Time frame: Day 0 - 168 (or end of treatment)
Rate of Mtb-cfDNA clearance derived from serial Mtb-cfDNA measurements
Percentage of participants completing sampling schedule
Time frame: Day 0 - 168 (or end of treatment)
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. The data generated in this study belongs to the study group as a whole. The final database will be shared amongst the PI and key members of the research team. With participant's consent, clinical data and results from blood analyses stored in the database may be shared with researchers not directly involved in this study but only after the main paper has been published and in accordance with MORU guidelines on data sharing. The results of the study will be summarised in lay language, in both English and the language(s) commonly spoken at the study site, and disseminated to participants and the community. The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any other publications arising from the study. Authorship will be determined in accordance with the International Committee of Medical Journal Editors (ICMJE) guidelines and other contributors will be acknowledged.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy Seers, Dr principal investigator
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycobacterium Tuberculosis and Tuberculosis, Pulmonary, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Htet Ko Ko Aung, Dr (055 581 135 ext. 109, htetkoko@shoklo-unit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mtb-cfDNA trajectories (time frame: Day 0 - 168 (or end of treatment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.