Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Oxford
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Exposure to antituberculosis treatment in the last 8 weeks (or Mycobacterium tuberculosis (Mtb.) active fluoroquinolone)
Known history of underlying malignancy
Pregnancy
Transfusion dependent anaemia
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
140 Participants
are grouped into 2 trial groupsGroup A: Group 1: Assay development and validation
Group B: Group 2: Longitudinal Assessment
Trial outcomes
Primary outcomes
1
Mtb-cfDNA trajectories
Rate of Mtb-cfDNA clearance derived from serial Mtb-cfDNA measurements
Time frame
Day 0 - 168 (or end of treatment)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)Sponsors and contacts
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Source ClinicalTrials.gov