Sputum-free Diagnostis of TB

Recruiting now

Conditions studied: Tuberculosis

In brief

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.

Key facts

Study ID

NCT07125274

Run by

Research Center Borstel

People needed

100

Starts

2025-06-06

Expected to finish

2026-12-01

Last updated by the study team

2025-08-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Lack of ability to provide informed consent
• Age < 18 years
• Pregnancy

Where it is running

• Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany — Hamburg, Germany (enrolling)

Full record on ClinicalTrials.gov

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