MBLA to Differentiate IRIS From Treatment Failure in Extrapulmonary Tuberculosis

The Molecular Bacterial Load Assay (MBLA) to Differentiate Immune Reconstitution Inflammatory Syndrome (IRIS) From Treatment Failure in Extrapulmonary Tuberculosis With Paradoxical Lymph Node Swelling.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07778082

Acronym

MBLA_IRIS

Enrollment

100

Registered

2026-08-21

Start date

2026-09-01

Completion date

2030-09-01

Last updated

2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extrapulmonary Tuberculosis

Keywords

MBLA, IRIS, Lymph node swelling

Brief 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.

Interventions

DIAGNOSTIC_TESTMBLA 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Concordance with culture results	2029	Concordance of MBLA results with liquid culture results (number and percentage of patients that were positive in both tests, only in one test, or negative in both tests).
Correlation of MBLA with clinical decision-making and patient outcomes	2029	Correlation of MBLA with clinical decision-making and composit patient outcome, including treatment extension or modification, long-term resolution of lymphadenopathy (number and percentage of patients in subgroups defined by: MBLA positive or negative; decision to treat or not to treat for potential relapse (not based on MBLA); clinical improvement or deterioration)

Secondary

Measure	Time frame	Description
Detection of non-viable bacilli	2029	Proportion of patients with positive Xpert MTB/RIF but negative MBLA, indicating possible detection of non-viable bacilli.
Treatment modification or extension based on clinical suspicion of failure or IRIS	2029	Rate of treatment modification or extension based on clinical suspicion of failure or IRIS, and its alignment with MBLA findings.
Clinical outcomes	2029	Number of patients with complete resolution/persistent disease, need for retreatment or escalation of therapy.

Countries

Germany

Contacts

CONTACTThomas Theo Brehm, PD Dr. med.

tbrehm@fz-borstel.de0049 4537 188 8080

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026