A Multicentric Cohort and Biomarker Study for Improved Care of Patients with Extrapulmonary Tuberculosis

Plain-language summary

This multicentre cohort study examines biomarkers to help improve the care of patients with extrapulmonary tuberculosis. Adults aged 18 and older with confirmed tuberculosis infection whose disease mainly involves sites outside the lungs (such as the pleura, lymph nodes, bones, or kidneys) may take part. Conducted by University of Cologne, this study without an assigned phase is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

University of Cologne

Intervention

biomarker analysis

Start date

3/6/2023

Estimated completion

12/31/2025

Countries

Germany

Related genes

Locations

• Bonn, Germany
• Borstel, Germany
• Cologne, Germany
• Frankfurt, Germany
• Hamburg, Germany
• Heidelberg, Germany

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.