Extrapulmonary TuberculosisMBLA_IRISNCT07778082
MBLA to Differentiate IRIS From Treatment Failure in Extrapulmonary Tuberculosis
An observational study of Extrapulmonary Tuberculosis, run by Research Center Borstel at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extrapulmonary Tuberculosis
- What is being tested?
- MBLA from routine lymph node aspirate
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2026to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with tuberculosis and progressive or persistant lymphadenopathy after at least 3 months of TB treatment will be recruited at the study sites. Eligible patients will be contacted by the clinicians responsible for TB treatment and/or follow-up care or by the local principal investigator.
Who may be able to join
- 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
Who cannot join
- Lack of capacity to provide informed consent
- Age < 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Research Center Borstel, Leibniz Lung Center
Borstel, 23845
Niklas Köhler, Dr. med., 0049 4537 188 8080, studienzentrum@fz-borstel.de
About this study
Official 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.
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
- Being tested
- MBLA from routine lymph node aspirate
- Keywords
- MBLA, IRIS, Lymph node swelling
- Medical subject headings
- Tuberculosis, Extrapulmonary, Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBLA from routine lymph node aspirateDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with extrapulmonary tuberculosis and lymph node swelling | Not described Receives: Diagnostic Test: MBLA from routine lymph node aspirate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance with culture results
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).
Measured: 2029
Correlation of MBLA with clinical decision-making and patient outcomes
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)
Measured: 2029
Secondary outcomes (3)
Detection of non-viable bacilli
Proportion of patients with positive Xpert MTB/RIF but negative MBLA, indicating possible detection of non-viable bacilli.
Measured: 2029
Treatment modification or extension based on clinical suspicion of failure or IRIS
Rate of treatment modification or extension based on clinical suspicion of failure or IRIS, and its alignment with MBLA findings.
Measured: 2029
Clinical outcomes
Number of patients with complete resolution/persistent disease, need for retreatment or escalation of therapy.
Measured: 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2029 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrapulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center Borstel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Theo Brehm, Research Center Borstel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778082
- Sponsor's protocol ID
- MBLA_IRIS
- Acronym
- MBLA_IRIS
- Status last verified
- Jul 2026
- First submitted
- 17 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07778082
- Acronym / sponsor ID
- MBLA_IRIS / MBLA_IRIS
- Conditions
- Extrapulmonary Tuberculosis
- Keywords
- MBLA, IRIS, Lymph node swelling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Research Center BorstelUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with extrapulmonary tuberculosis and lymph node swelling | – | Diagnostic Test: MBLA from routine lymph node aspirate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with tuberculosis and progressive or persistant lymphadenopathy after at least 3 months of TB treatment will be recruited at the study sites. Eligible patients will be contacted by the clinicians responsible for TB treatment and/or follow-up care or by the local principal investigator.
Key inclusion criteria (6 listed)
- Patient with extrapulmonary tuberculosis
- Progressive or persistant lymphadenopathy
- Treatment for tuberculosis for at least 3 months
- Age ≥ 18 years
- Capacity to provide informed consent
Key exclusion criteria (2 listed)
- Lack of capacity to provide informed consent
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBLA from routine lymph node aspirateLymph 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. | Diagnostic test | Patients with extrapulmonary tuberculosis and lymph node swelling |
Primary outcome
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).
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)
3 secondary outcomes
Detection of non-viable bacilli
Time frame: 2029
Treatment modification or extension based on clinical suspicion of failure or IRIS
Time frame: 2029
Clinical outcomes
Time frame: 2029
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extrapulmonary Tuberculosis, run by Research Center Borstel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Theo Brehm, PD Dr. med. (0049 4537 188 8080, tbrehm@fz-borstel.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance with culture results (time frame: 2029). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.