Sputum-free Diagnostis of TB
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 t
| Condition(s) | Tuberculosis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Research Center Borstel |
| Locations | Hamburg, Germany |
| Start date | 2025-06-06 |
| NCT ID | NCT07125274 |
| Official listing | https://clinicaltrials.gov/study/NCT07125274 |