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RECRUITINGOBSERVATIONAL

Sputum-free Diagnostis of TB

Biomarker-guided Diagnosis of Tuberculosis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form - Willingness to participate in the study Who Should NOT Join This Trial: - Lack of ability to provide willing to sign a consent form - Age \< 18 years - Pregnancy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

Biomarker-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.

Locations (1)

Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Hamburg, Germany