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MBLA to Differentiate IRIS From Treatment Failure in Extrapulmonary Tuberculosis
Sponsor: Research Center Borstel
Summary
This prospective, multi-center study aims to evaluate the Molecular Bacterial Load Assay (MBLA) on lymph node aspirates as a tool to distinguish between late immune reconstitution inflammatory syndrome (IRIS) and treatment failure in patients with extrapulmonary tuberculosis (TB) presenting with paradoxical lymph node swelling. The study will compare MBLA results with Xpert MTB/RIF and culture findings and assess their correlation with patient outcomes. By quantifying viable M. tuberculosis via 16S rRNA detection, MBLA may offer a rapid, culture-independent method to inform clinical decisions and reduce overtreatment.
Official title: The Molecular Bacterial Load Assay (MBLA) to Differentiate Immune Reconstitution Inflammatory Syndrome (IRIS) From Treatment Failure in Extrapulmonary Tuberculosis With Paradoxical Lymph Node Swelling.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2026-09
Completion Date
2030-09
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
MBLA from routine lymph node aspirate
Lymph node aspirates that are collected for routine diagnosis will be split if material is sufficient. A part of the material will be assessed with MBLA for living Mycobacterium tuberculosis.
Locations (1)
Research Center Borstel, Leibniz Lung Center
Borstel, Germany