Actively Recruiting

Age: 18Years +
All Genders
ID06875336

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

Led by University of Cologne · Updated on 2025-03-13

150

Participants Needed

6

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Cologne

Lead Sponsor

U

University Hospital, Bonn

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating extrapulmonary tuberculosis (EPTB), a form of tuberculosis that affects organs other than the lungs. This observational study involves adults newly diagnosed with EPTB and aims to improve clinical management by developing specific biomarkers for diagnosis and treatment monitoring. The study also includes pulmonary TB patients and healthy controls to support laboratory analyses and comparisons. The research is conducted across multiple centers in Germany, addressing the rising proportion of EPTB cases and challenges in treatment evaluation. Participants receive standard clinical care while clinical data and biological samples such as blood and urine are collected throughout their treatment. The study has several groups based on the extent of sample collection, including patients with full and partial samples and healthy controls. Data collection points occur at diagnosis, during treatment at 4 weeks, 3 months, and 6 months, and after treatment completion, with additional follow-up for longer treatments. Biomarker analyses include gene expression and T-cell assays, with samples stored centrally for detailed laboratory studies. During study visits, routine clinical assessments such as symptom evaluation, laboratory tests, and imaging (ultrasound, CT, MRI) are performed. Researchers collect sputum and urine samples for microbiological testing and gather data using case report forms transferred to an electronic database. Outcomes focus on blood biomarkers for diagnosis and treatment response, correlated with clinical signs like symptom improvement and weight gain. This comprehensive approach aims to better predict treatment success and guide future EPTB care strategies over a two-year period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of extrapulmonary tuberculosis confirmed by PCR, culture, or clinical findings
  • Involvement of organs such as pleura, lymph nodes, bones, joints, larynx, pericardium, parotid gland, abdomen, kidneys, genitourinary tract, or disseminated TB
  • Leading clinical and radiographic manifestation must be extrapulmonary if pulmonary involvement is also present
  • Written informed consent provided prior to participation
Not Eligible

You will not qualify if you...

  • Age younger than 18 years
  • Any social or logistical condition that may interfere with study participation, such as inability to understand study procedures or anticipated inability to complete the study
  • Close dependency on the study team (e.g., family members or employees of the same department)
  • Pregnant women
  • Patients in custodianship or guardianship
  • Leading pulmonary tuberculosis manifestation
  • Solitary central nervous system tuberculosis
  • Participation in other clinical studies allowed only if no conflicts with this study's criteria and procedures

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 2 years

Participants with extrapulmonary tuberculosis will have routine clinical and laboratory parameters, radiographic imaging, and microbiology specimens collected. Additional blood and urine samples will be collected at multiple time points to assess biomarkers related to diagnosis and treatment response.

Visits at diagnosis/treatment initiation, 4 weeks, 3 months, 6 months post treatment initiation, and 3 months post end of treatment; additional visits if treatment extends beyond 6 months

Trial Site Locations

Total: 6 locations

1

University Hospital Bonn

Bonn, Germany, 53127

Not Yet Recruiting

2

Research Center Borstel

Borstel, Germany, 23845

Actively Recruiting

3

University Hospital of Cologne

Cologne, Germany, 50937

Actively Recruiting

4

University Hospital Frankfurt

Frankfurt, Germany, 60590 Frankfurt

Not Yet Recruiting

5

University Hospital Hamburg

Hamburg, Germany, 20251 Hamburg

Actively Recruiting

6

University Hospital Heidelberg

Heidelberg, Germany, 69120

Actively Recruiting

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Research Team

I

Isabelle Suarez, Dr

A

Angela Klingmüller, Dr

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Frequently Asked Questions

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Published Research Related To This Trial

Corticosteroids inhibit Mycobacterium tuberculosis-induced necrotic host cell death by abrogating mitochondrial membrane permeability transition.

Jessica Gräb, Isabelle Suárez, Edeltraud van Gumpel...

https://pubmed.ncbi.nlm.nih.gov/30737374

Performance of diagnostic and predictive host blood transcriptomic signatures for Tuberculosis disease: A systematic review and meta-analysis.

Humphrey Mulenga, Chambrez-Zita Zauchenberger, Erick W Bunyasi...

https://pubmed.ncbi.nlm.nih.gov/32822359

[Tuberculosis Guideline for Adults - Guideline for Diagnosis and Treatment of Tuberculosis including LTBI Testing and Treatment of the German Central Committee (DZK) and the German Respiratory Society (DGP)].

Tom Schaberg, Torsten Bauer, Folke Brinkmann...

https://pubmed.ncbi.nlm.nih.gov/28651293