NCT06845618

Blood Tuberculosis DNA Levels to Monitor Tuberculosis Treatment

Mycobacterium Tuberculosis Complex Cell-free DNA (Mtb-cfDNA) for the Pharmacometric Assessment of Anti-tuberculosis Treatment: a Proof-of-concept Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

This study is funded by the Wellcome Trust; grant reference number: 223099/Z/21/Z

Conditions

• Mycobacterium Tuberculosis
• Tuberculosis, Pulmonary
• Tuberculosis, Extra-Pulmonary

Timeline

• Start date: 2025-07-21
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2025-02-25
• Last updated: 2026-04-13

Locations

1 site across 1 country: Thailand