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MBLA to Differentiate IRIS From Treatment Failure in Extrapulmonary Tuberculosis

Not Yet RecruitingN/A

Sponsor: Research Center Borstel

Conditions: Extrapulmonary Tuberculosis

Interventions: MBLA from routine lymph node aspirate

Countries: Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

Borstel, Germany