Sputum-free Diagnostis of TB
ConditionTuberculosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorResearch Center Borstel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Lack of ability to provide informed consent
Age < 18 years
Pregnancy
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biomarker-guided diagnostic tests
Diagnostic testmRNA-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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Patients with suspected TB1 intervention
Group B: Other pulmonary infections (control group)1 intervention
Trial outcomes
Primary outcomes
1
Feasibility 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 treatment2
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 treatment3
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 treatment4
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 treatmentSecondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
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Source ClinicalTrials.gov