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MBLA to Differentiate IRIS From Treatment Failure in Extrapulmonary Tuberculosis

Study acronym: MBLA_IRIS
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 1 of 3 entriesv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07778082
Lead Sponsor Research Center Borstel
Conditions
(from sponsor)		 Extrapulmonary Tuberculosis
Related terms Lymphadenopathy, Tuberculosis, Extrapulmonary
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov