Tuberculosis
Conditions
Keywords
TB, diagnostics, sputum, sputum-free, transcriptomic, pathfast, CRISPR, stool, PCR
Brief summary
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.
Interventions
DIAGNOSTIC_TESTBiomarker-guided diagnostic tests
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.
Sponsors
Research Center Borstel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suspected pulmonary or extrapulmonary tuberculosis, or confirmed pulmonary or extrapulmonary tuberculosis with less than 7 days of anti-tuberculosis treatment, OR other pulmonary infection (control group). * Age ≥ 18 years * Ability to provide informed consent * Willingness to participate in the study
Exclusion criteria
* Lack of ability to provide informed consent * Age \< 18 years * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of biomarker-guided diagnosis of TB - composit | From enrollment to the end of the first week of treatment | 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. |
| Feasibility of biomarker-guided diagnosis of TB - mRNA signatures | From enrollment to the end of the first week of treatment | Assessment of the feasibility of tuberculosis (TB) diagnostics based on mRNA signatures. |
| Feasibility of biomarker-guided diagnosis of TB - cellular immunology | From enrollment to the end of the first week of treatment | Assessment of the feasibility of tuberculosis (TB) diagnostics based on cellular immunology. |
| Feasibility of biomarker-guided diagnosis of TB - PATHFAST-LAM | From enrollment to the end of the first week of treatment | Assessment of the feasibility of tuberculosis (TB) diagnostics based on PATHFAST-LAM. |
| Feasibility of biomarker-guided diagnosis of TB - EclLAM | From enrollment to the end of the first week of treatment | Assessment of the feasibility of tuberculosis (TB) diagnostics based on EclLAM assays. |
| Feasibility of biomarker-guided diagnosis of TB - cell-free Mycobacterium tuberculosis DNA | From enrollment to the end of the first week of treatment | Assessment of the feasibility of tuberculosis (TB) diagnostics based on cell-free Mycobacterium tuberculosis DNA. |
| Feasibility of biomarker-guided diagnosis of TB - MBLA | From enrollment to the end of the first week of treatment | Assessment of the feasibility of tuberculosis (TB) diagnostics based on Mycobacterial Load Assay (MBLA). |
| Feasibility of biomarker-guided diagnosis of TB - stool PCR | From enrollment to the end of the first week of treatment | Assessment of the feasibility of tuberculosis (TB) diagnostics based on stool PCR testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Analysis of Biomarker Profiles and Their Clinical Associations | From enrollment to the end of the first week of treatment. | Degree of correlation between the different biomarkers. |
Countries
Germany
Contacts
Primary ContactThomas Theo Brehm, Dr. med.
Backup ContactNiklas Köhler, Dr. med.
Outcome results
None listed