A lab test to tell why lymph nodes swell in tuberculosis outside the lungs
Tests a bacteria-counting assay on lymph node samples in adults with extrapulmonary tuberculosis.
Plain-language title generated from the registry record
Registry title: MBLA to Differentiate IRIS From Treatment Failure in Extrapulmonary Tuberculosis
Key facts
- Where
- Borstel, GermanySee the site
Where in Germany
- Research Center Borstel, Leibniz Lung CenterBorstel, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Research Center Borstel
- Trial code
- NCT07778082
- Record updated
- 31 August 2026
- Original description
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.Read full original descriptionShow less
The Molecular Bacterial Load Assay (MBLA) to Differentiate Immune Reconstitution Inflammatory Syndrome (IRIS) From Treatment Failure in Extrapulmonary Tuberculosis With Paradoxical Lymph Node Swelling.
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.
Inclusion: 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: Age < 18 years; Lack of capacity to provide informed consent.