NCT07778082Not yet recruiting
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.
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 17 Aug 2026
- Start date
- Sept 2026
- Primary completion date
- Sept 2029
- Lead sponsor
- Research Center Borstel
- Diseases
- Tuberculosis
- NCT number
- NCT07778082
What you commit to
- Study type: Observational
- Planned participants: 100
- From Sept 2026 to the primary completion date, Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Age \< 18 years
Other
- Lack of capacity to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Center Borstel, Leibniz Lung Center Coordinator of this site? Confirm its status | Borstel | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.