MBLA to Differentiate IRIS From Treatment Failure in Extrapulmonary Tuberculosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorResearch Center Borstel

About this trial

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 criteria

Qualifiers

Patient with extrapulmonary tuberculosis

Progressive or persistant lymphadenopathy

Treatment for tuberculosis for at least 3 months

Age ≥ 18 years

Disqualifiers

Lack of capacity to provide informed consent

Age < 18 years

Trial design

Treatments tested in this trial

  • MBLA from routine lymph node aspirate

Treatment groups

100 Participants
are divided into 1 treatment group

Sponsors and collaborators