Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment
NCT ID: NCT06845618
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
140 participants
OBSERVATIONAL
2026-02-01
2027-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Timothy Seers, Dr
Role: PRINCIPAL_INVESTIGATOR
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University.
Locations
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Shoklo Malaria Research Unit (SMRU)
Tak, , Thailand
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MYC24003
Identifier Type: -
Identifier Source: org_study_id
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