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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patient with extrapulmonary tuberculosis
* Progressive or persistant lymphadenopathy
* Treatment for tuberculosis for at least 3 months
* Age ≥ 18 years
* Capacity to provide informed consent
* Written informed consent to participate in the study
Exclusion Criteria:
* Lack of capacity to provide informed consent
* Age \< 18 years
Primary outcome measure(s)
Concordance with culture results — 2029 Concordance of MBLA results with liquid culture results (number and percentage of patients that were positive in both tests, only in one test, or negative in both tests).
Correlation of MBLA with clinical decision-making and patient outcomes — 2029 Correlation of MBLA with clinical decision-making and composit patient outcome, including treatment extension or modification, long-term resolution of lymphadenopathy (number and percentage of patients in subgroups defined by: MBLA positive or negative; decision to treat or not to treat for potential relapse (not based on MBLA); clinical improvement or deterioration)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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