RECRUITINGOBSERVATIONAL

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

About This Trial

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 the study. Clinical data will be collected using standardized questionnaires over the whole treatment period for each individual. Additionally, body fluids (blood, urine) will be collected and stored in a central biobank. Biomarkers in EPTB patients will be analyzed during the course of therapy and correlated with clinical data. In addition, a healthy control group will be added, to be used primarily as technical controls for complex laboratory procedures such as RNA-seq and T-cell based assays.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form provided prior to inclusion Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DIAGNOSTIC_TEST

biomarker analysis

PAXgene blood for RNA will be collected and stored. Results from these additional examinations are not included in the treatment monitoring of the patient concerned. If M. tuberculosis can be cultivated, strains will be stored for genotyping and whole genome sequencing. Serum biomarkers will be tested using commercially available kits. In addition, TAM-TB assays will be performed from samples stored at each time-point. For this purpose, PBMCs will be collected and frozen using well-established protocols.

Locations (6)

University Hospital Bonn

Bonn, Germany

Research Center Borstel

Borstel, Germany

University Hospital of Cologne

Cologne, Germany

University Hospital Frankfurt

Frankfurt, Germany

University Hospital Hamburg

Hamburg, Germany

University Hospital Heidelberg

Heidelberg, Germany