Status:
RECRUITING
A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis
Lead Sponsor:
University of Cologne
Collaborating Sponsors:
University Hospital, Bonn
Research Center Borstel
Conditions:
Extrapulmonary Tuberculosis
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, multicenter, observational study (mEX-TB study) of patients with extrapulmonary tuberculosis (EPTB). Adult patients newly diagnosed with EPTB will prospectively be enrolled into...
Detailed Description
Background: According to the World Health Organization (WHO), 10 million people fell ill with tuberculosis (TB) in 2019, and 1.4 million people died from this disease. Among infectious agents, Mycobac...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Isolation of Mycobacterium tuberculosis complex from a bodily secretion or tissue by
- PCR
- culture or a presumptive clinical diagnosis based on epidemiologic exposure in combination with physical findings, radiographic findings and/or histopathology
- 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
- In the case of pulmonary and extrapulmonary involvement, the leading manifestation, clinically and radiographically, must be extrapulmonary.
- Written informed consent provided prior to inclusion
Exclusion
- 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.
Key Trial Info
Start Date :
March 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06875336
Start Date
March 6 2023
End Date
December 31 2025
Last Update
March 13 2025
Active Locations (6)
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1
University Hospital Bonn
Bonn, Germany, 53127
2
Research Center Borstel
Borstel, Germany, 23845
3
University Hospital of Cologne
Cologne, Germany, 50937
4
University Hospital Frankfurt
Frankfurt, Germany, 60590 Frankfurt