Improving care for patients with extrapulmonary tuberculosis
A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis
This study is trying to improve care for adults newly diagnosed with extrapulmonary tuberculosis by collecting their health information and samples to better understand the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Cologne Academic / other |
| Locations | 6 sites (Bonn and 5 other locations) |
| Trial ID | NCT06875336 on ClinicalTrials.gov |
What this trial studies
This multicentric observational study focuses on adult patients newly diagnosed with extrapulmonary tuberculosis (EPTB). Participants will be enrolled prospectively, and their clinical data will be collected through standardized questionnaires throughout their treatment. Additionally, body fluids such as blood and urine will be collected for biomarker analysis, which will be correlated with clinical data to enhance understanding of EPTB. A healthy control group will also be included for technical comparisons in laboratory analyses.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been newly diagnosed with extrapulmonary tuberculosis.
Not a fit: Patients under 18 years of age or those with conditions that may interfere with study participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment strategies for patients with extrapulmonary tuberculosis.
How similar studies have performed: Other studies have shown success in using biomarker analysis for tuberculosis, but this specific approach focusing on extrapulmonary cases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Isolation of Mycobacterium tuberculosis complex from a bodily secretion or tissue by 1. PCR 2. culture or a presumptive clinical diagnosis based on epidemiologic exposure in combination with physical findings, radiographic findings and/or histopathology 3. Patients with extrapulmonary TB * pleura * lymph nodes * bones and joints * larynx * pericardial * parotid gland * abdominal sites * kidneys * genitourinary tract * disseminated (miliary) TB * other than pulmonary TB 4. In the case of pulmonary and extrapulmonary involvement, the leading manifestation, clinically and radiographically, must be extrapulmonary. 5. Written informed consent provided prior to inclusion Exclusion Criteria: * 1\. Age \<18 years 2. Patient with any social or logistical condition which, as anticipated by the investigator, may interfere with the conduct of the study, such as incapacity to well understand the study content and procedure (in case of any language barriers, a translator may be involved), not willing to collaborate, or anticipated inability to finish study due to physical weakness 3. Dependencies towards the study team (e.g. family members, employees of the same department) 4. Pregnant women 5. Patient in custodianship or guardianship 6. Leading pulmonary manifestation 7. Solitary CNS tuberculosis Patients may take part in other clinical studies and trials, as long as there is no conflict with the inclusion or exclusion criteria of the mEX-TB study and the protocol of the other study or trial does not conflict with the means of data and sample collection and publication of this protocol.
Where this trial is running
Bonn and 5 other locations
- University Hospital Bonn — Bonn, Germany (Not_yet_recruiting)
- Research Center Borstel — Borstel, Germany (Recruiting)
- University Hospital of Cologne — Cologne, Germany (Recruiting)
- University Hospital Frankfurt — Frankfurt, Germany (Not_yet_recruiting)
- University Hospital Hamburg — Hamburg, Germany (Recruiting)
- University Hospital Heidelberg — Heidelberg, Germany (Recruiting)
Study contacts
- Study coordinator: Isabelle Suarez, Dr
- Email: isabelle.suarez@uk-koeln.de
- Phone: +49 (221) 478-39680
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.