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.
Patient with extrapulmonary tuberculosis
Progressive or persistant lymphadenopathy
Treatment for tuberculosis for at least 3 months
Age ≥ 18 years
Lack of capacity to provide informed consent
Age < 18 years
Patients with tuberculosis and progressive or persistant lymphadenopathy after at least 3 months of TB treatment will be recruited at the study sites. Eligible patients will be contacted by the clinicians responsible for TB treatment and/or follow-up care or by the local principal investigator.
Cohort
Prospective
MBLA from routine lymph node aspirate
Diagnostic testLymph 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.
Concordance with culture results
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
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)
Detection of non-viable bacilli
Proportion of patients with positive Xpert MTB/RIF but negative MBLA, indicating possible detection of non-viable bacilli.
Treatment modification or extension based on clinical suspicion of failure or IRIS
Rate of treatment modification or extension based on clinical suspicion of failure or IRIS, and its alignment with MBLA findings.
Clinical outcomes
Number of patients with complete resolution/persistent disease, need for retreatment or escalation of therapy.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
