Multicenter Study to Improve Care and Biomarker Detection in Adults with Extrapulmonary Tuberculosis

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.

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