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.
Study Type
OBSERVATIONAL
Enrollment
100
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.
Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Hamburg, Germany
RECRUITINGFeasibility of biomarker-guided diagnosis of TB - mRNA signatures
Assessment of the feasibility of tuberculosis (TB) diagnostics based on mRNA signatures.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: From enrollment to the end of the first week of treatment
Feasibility of biomarker-guided diagnosis of TB - stool PCR
Assessment of the feasibility of tuberculosis (TB) diagnostics based on stool PCR testing.
Time frame: 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.
Time frame: From enrollment to the end of the first week of treatment
Exploratory Analysis of Biomarker Profiles and Their Clinical Associations
Degree of correlation between the different biomarkers.
Time frame: 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 differences in biomarker profiles between pulmonary and extrapulmonary tuberculosis.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of the first week of treatment.
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