Sputum-free diagnosis of tuberculosis
Biomarker-guided Diagnosis of Tuberculosis
Research Center Borstel · NCT07125274
This study will test whether blood, urine, or stool samples can diagnose tuberculosis in adults suspected of TB, including people who cannot produce sputum.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Research Center Borstel (other) |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT07125274 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (age ≥18) with suspected or recently confirmed pulmonary or extrapulmonary TB, or adults with other pulmonary infections enrolled as controls, who can give informed consent are eligible.
Not a fit: People under 18, pregnant individuals, or those unable to provide informed consent are excluded and would not be eligible to participate or benefit from this study.
Why it matters
Potential benefit: If successful, the approach could enable non-invasive, more accessible TB diagnosis for patients who cannot produce sputum, leading to earlier treatment.
How similar studies have performed: Previous studies have shown promising blood transcriptomic and urine biomarker signatures for TB, but these approaches have not yet replaced conventional sputum-based diagnostics, so the method is promising but not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hamburg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tuberculosis, TB, diagnostics, sputum, sputum-free, transcriptomic, pathfast, CRISPR