NCT06845618 Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment
| NCT ID | NCT06845618 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Oxford |
| Condition | Mycobacterium Tuberculosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-07-21 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2025-07-21 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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
Eligibility Criteria
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
Contact & Investigator
Timothy Seers, Dr
PRINCIPAL INVESTIGATOR
Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University.
Frequently Asked Questions
Who can join the NCT06845618 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mycobacterium Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06845618 currently recruiting?
Yes, NCT06845618 is actively recruiting participants. Contact the research team at htetkoko@shoklo-unit.com for enrollment information.
Where is the NCT06845618 trial being conducted?
This trial is being conducted at Tak, Thailand.
Who is sponsoring the NCT06845618 clinical trial?
NCT06845618 is sponsored by University of Oxford. The principal investigator is Timothy Seers, Dr at Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University.. The trial plans to enroll 140 participants.