Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT06845618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-19
First Post:
2025-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
Mycobacterium Tuberculosis Complex Cell-free DNA (Mtb-cfDNA) for the Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mtb-Dynamic
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: