Sputum-free diagnosis of tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, prospective observational study enrolling adults evaluated for suspected or recently confirmed tuberculosis as well as control patients with other pulmonary infections. Participants provide one set of biomaterial samples (blood, urine, stool, and sputum when available) during routine clinical care, with no extra invasive procedures required. Collected samples will undergo multiple diagnostic and transcriptomic analyses to identify individual and combined biomarker signatures that distinguish TB from other conditions. The goal is to determine whether non-sputum markers can reliably detect TB, including in patients unable to produce sputum.

Why it matters

Who can join: the full rules

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

Where it's running

• Division of Infectious Diseases, I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
  Hamburg, Germany Recruiting

Study contacts

• Study coordinator: Thomas Theo Brehm, Dr. med.
• Email: tbrehm@fz-borstel.de
• Phone: +49 4537 188 2905

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.