Sputum-free Diagnostis of TB (TB_Diagnostics)

Research Center Borstel

Status: Enrolling

Conditions: Tuberculosis

Treatments: Diagnostic Test: Biomarker-guided diagnostic tests

Study type: Observational

Funder types: Other

Identifiers

NCT07125274

TBDiagnostics2025-101457-BO-ff

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Patients with suspected TB

Treatment:

Diagnostic Test: Biomarker-guided diagnostic tests

Other pulmonary infections (control group)

Treatment:

Diagnostic Test: Biomarker-guided diagnostic tests