Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mycobacterium Tuberculosis, Tuberculosis, Pulmonary, Tuberculosis, Extra-Pulmonary. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mycobacterium Tuberculosis Complex Cell-free DNA (Mtb-cfDNA) for the Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study
Overview
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
Detailed description
This study is funded by the Wellcome Trust; grant reference number: 223099/Z/21/Z
Primary outcome measures
- Mtb-cfDNA trajectories [Time frame: Day 0 - 168 (or end of treatment)]
- Percentage of participants completing sampling schedule [Time frame: Day 0 - 168 (or end of treatment)]
Secondary outcome measures (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)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Thailand · 1 center
- Shoklo Malaria Research Unit (SMRU) — Tak
Identifiers
NCT: NCT06845618 · MYC24003