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MBLA to Differentiate IRIS From Treatment Failure in Extrapulmonary Tuberculosis

NCT07778082 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-08-31

No results posted yet for this study

Summary

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.

Conditions

  • Extrapulmonary Tuberculosis

Interventions

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.

Sponsors & Collaborators

  • Research Center Borstel

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-09-30
Completion
2030-09-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778082 on ClinicalTrials.gov