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The aim of this study is to identify new biomarkers that enable reliable, non-invasive diagnosis of tuberculosis (TB), including in patients who are unable to produce sputum. The study analyzes biomaterials (blood, urine, stool, sputum) collected from patients with suspected TB. Various diagnostic methods are applied to assess the feasibility of individual and combined biomarker tests.
Participating patients will provide biomaterial samples (blood, urine, stool, sputum) once. No additional examinations or invasive procedures will be performed. Routine diagnostic procedures remain unaffected.
This is a single-center, prospective observational study. Patients are enrolled as part of their clinical care at the University Medical Center Hamburg-Eppendorf.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with suspected TB |
| ||
| Other pulmonary infections (control group) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker-guided diagnostic tests | Diagnostic Test | mRNA-Signature from blood; immunophenotyping from blood; MBLA from sputum, PATHFAST-LAM and EclLAM from sputum, stool, urine; CRISPR-Cas from blood; stool PCR; QuantiFERON(R)-TB Gold Plus. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of biomarker-guided diagnosis of TB - mRNA signatures | Assessment of the feasibility of tuberculosis (TB) diagnostics based on mRNA signatures. | From enrollment to the end of the first week of treatment |
| Feasibility of biomarker-guided diagnosis of TB - cellular immunology | Assessment of the feasibility of tuberculosis (TB) diagnostics based on cellular immunology. | From enrollment to the end of the first week of treatment |
| Feasibility of biomarker-guided diagnosis of TB - PATHFAST-LAM | Assessment of the feasibility of tuberculosis (TB) diagnostics based on PATHFAST-LAM. | From enrollment to the end of the first week of treatment |
| Feasibility of biomarker-guided diagnosis of TB - EclLAM | Assessment of the feasibility of tuberculosis (TB) diagnostics based on EclLAM assays. | From enrollment to the end of the first week of treatment |
| Feasibility of biomarker-guided diagnosis of TB - cell-free Mycobacterium tuberculosis DNA | Assessment of the feasibility of tuberculosis (TB) diagnostics based on cell-free Mycobacterium tuberculosis DNA. | From enrollment to the end of the first week of treatment |
| Feasibility of biomarker-guided diagnosis of TB - MBLA | Assessment of the feasibility of tuberculosis (TB) diagnostics based on Mycobacterial Load Assay (MBLA). | From enrollment to the end of the first week of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Analysis of Biomarker Profiles and Their Clinical Associations | Degree of correlation between the different biomarkers. | From enrollment to the end of the first week of treatment. |
| Exploratory Analysis of Biomarker Profiles and Their Clinical Associations |
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Inclusion Criteria:
Exclusion Criteria:
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Patients > 18 years of age, including women of childbearing potential with or without contraception. Only adult patients capable of giving informed consent will be included; obtaining consent from legal guardians is not planned.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Theo Brehm, Dr. med. | Contact | +49 4537 188 2905 | tbrehm@fz-borstel.de | |
| Niklas Köhler, Dr. med. | Contact | +49 4537 188 8080 | nkoehler@fz-borstel.de |
| Name | Affiliation | Role |
|---|---|---|
| Christoph Lange, Prof. Dr. Dr. h.c. | Clinical Infectious Diseases, Research Center Borstel, Leibniz Lung Center | Study Chair |
| Marylyn Martina Addo, Prof. Dr. | Institute for Infection Research and Vaccine Development, University Medical Center Hamburg-Eppendorf |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany | Recruiting | Hamburg | 20246 | Germany |
all IPD collected throughout the trial
Starting mid 2027
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Feasibility of biomarker-guided diagnosis of TB - stool PCR |
Assessment of the feasibility of tuberculosis (TB) diagnostics based on stool PCR testing. |
| From enrollment to the end of the first week of treatment |
| Feasibility of biomarker-guided diagnosis of TB - composit | Assessment of the feasibility of tuberculosis (TB) diagnostics based on a combination of mRNA signatures, cellular immunology, PATHFAST-LAM and EclLAM assays, cell-free Mycobacterium tuberculosis DNA analysis, MBLA, stool PCR testing, and QuantiFERON®-TB Gold Plus testing. | From enrollment to the end of the first week of treatment |
Qualitative and quantitative characterization of differences in biomarker profiles between pulmonary and extrapulmonary tuberculosis. |
| From enrollment to the end of the first week of treatment. |
| Exploratory Analysis of Biomarker Profiles and Their Clinical Associations | Qualitative and quantitative characterization of sex-specific differences in biomarker expression patterns. | From enrollment to the end of the first week of treatment. |
| Exploratory Analysis of Biomarker Profiles and Their Clinical Associations | Degree of correlation between biomarkers and disease severity, as well as their potential prognostic value. | From enrollment to the end of the first week of treatment. |
| Stefan Schmiedel, Dr. med. | Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany | Study Chair |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |