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NCT Number: NCT07778082

MBLA to Differentiate IRIS From Treatment Failure in Extrapulmonary Tuberculosis

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.

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Key information

Conditions

Extrapulmonary Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Hemic and Lymphatic Diseases Infections Lymphadenopathy Lymphatic Diseases Mycobacterium Infections Tuberculosis Tuberculosis, Extrapulmonary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBLA from routine lymph node aspirate

Diagnostic Test

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.

Primary outcomes

  1. Concordance with culture results

    Time frame: 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).

  2. Correlation of MBLA with clinical decision-making and patient outcomes

    Time frame: 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 outcomes

  1. Detection of non-viable bacilli

    Time frame: 2029

    Proportion of patients with positive Xpert MTB/RIF but negative MBLA, indicating possible detection of non-viable bacilli.

  2. Treatment modification or extension based on clinical suspicion of failure or IRIS

    Time frame: 2029

    Rate of treatment modification or extension based on clinical suspicion of failure or IRIS, and its alignment with MBLA findings.

  3. Clinical outcomes

    Time frame: 2029

    Number of patients with complete resolution/persistent disease, need for retreatment or escalation of therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas Theo Brehm, PD Dr. med.

CONTACT

[email protected]

0049 4537 188 8080

Sponsors and collaborators

Lead sponsor

Research Center Borstel

Other

Registry information

Official study title

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

Acronym: MBLA_IRIS

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Aug 21, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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