Sputum-free Diagnostis of TB

ConditionTuberculosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorResearch Center Borstel

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Lack of ability to provide informed consent

Age < 18 years

Pregnancy

Trial design

Treatments tested in this trial

  • Biomarker-guided diagnostic tests

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators