Improving care for patients with extrapulmonary 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 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.

Why it matters

Who can join: the full rules

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 it's running

• Research Center Borstel
  Borstel, Germany Recruiting
• University Hospital of Cologne
  Cologne, Germany Recruiting
• University Hospital Hamburg
  Hamburg, Germany Recruiting
• University Hospital Heidelberg
  Heidelberg, Germany Recruiting
• University Hospital Bonn
  Bonn, Germany Not yet recruiting
• University Hospital Frankfurt
  Frankfurt, Germany Not yet recruiting

Study contacts

• Study coordinator: Isabelle Suarez, Dr
• Email: isabelle.suarez@uk-koeln.de
• Phone: +49 (221) 478-39680

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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.