An observational study in Extrapulmonary Tuberculosis, sponsored by Research Center Borstel. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Research Center Borstel · Observational
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.
77 studies on the registry are indexed under Lymphadenopathy; 14 are open to participants now.
This study's planned enrollment of 100 is below the median of 139 across 22 observational studies indexed under Lymphadenopathy.
Browse Lymphadenopathy studies →Research Center Borstel is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: 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.
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).
Time frame: 2029
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)
Time frame: 2029
Detection of non-viable bacilli
Proportion of patients with positive Xpert MTB/RIF but negative MBLA, indicating possible detection of non-viable bacilli.
Time frame: 2029
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.
Time frame: 2029
Clinical outcomes
Number of patients with complete resolution/persistent disease, need for retreatment or escalation of therapy.
Time frame: 2029
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Research Center Borstel