Testing new non-sputum tests to diagnose tuberculosis
Tests new biomarkers in blood, urine, stool and sputum from adults with suspected tuberculosis.
Plain-language title generated from the registry record
Registry title: Sputum-free Diagnostis of TB
Key facts
- Where
- Hamburg, GermanySee the site
Where in Germany
- Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, GermanyHamburg, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Research Center Borstel
- Trial code
- NCT07125274
- Record updated
- 15 August 2025
- Original description
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.Read full original descriptionShow less
Biomarker-guided Diagnosis of Tuberculosis
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.
Inclusion: 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: Age < 18 years; Lack of ability to provide informed consent; Pregnancy.