Tuberculosis
Conditions
Keywords
registry, extrapulmonary tuberculosis, PTLD
Brief summary
The TBnet registry is a multinational, prospective tuberculosis registry established by the Tuberculosis Network European Trialsgroup (TBnet e.V.) to collect and analyze long-term data from TB patients across Europe. Its purpose is to centralize data on TB epidemiology, prevention, diagnosis, and treatment to improve care, support research, and ultimately help eliminate TB. The registry captures risk factors, diagnostic details (e.g., microbiology, imaging, drug resistance), treatment data, side effects, outcomes, and late complications.
Detailed description
In Western Europe, however, tuberculosis is a rare disease, and individual clinics see only small numbers of patients. For clinical research on the epidemiology, prevention, diagnosis, and treatment of tuberculosis, it is therefore essential that patient data are collected and analyzed in a centralized manner. This allows for the adequate inclusion of at-risk groups and studying less common forms of tuberculosis (e.g., multidrug-resistant tuberculosis, extrapulmonary tuberculosis). Hence, the Tuberculosis Network European Trialsgroup TBnet e.V., aims to establish a tuberculosis registry in which long-term datasets from TB patients across Europe will be stored. The findings obtained from the tuberculosis registry will make an important contribution to combating and ultimately eliminating TB. TBnet is a pan-European clinical research network dedicated to improving the diagnosis, treatment, and prevention of tuberculosis and related mycobacterial diseases. Founded in 2006, TBnet brings together clinicians, scientists, and public health experts from more than 30 countries. The network has established large collaborative cohorts and conducts multicenter clinical studies, registries, and consensus projects that have shaped international TB guidelines. The TBnet Steering Committee will serve as data access committee: Research questions/data inquiries will be submitted to the TBnet Steering Committee through a structured process on the TBnet website and are approved only after internal and external peer review (as outlined in the TBnet statutes).
Interventions
OTHERdata collection
Prospective data collection in a clinical data registry
Sponsors
Research Center Borstel
European Society of Clinical Microbiology and Infectious Diseases
Tuberculosis Network European Trialsgroup (TBnet e.V.)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Tuberculosis * Age ≥ 18 years * Capacity to provide informed consent * Written informed consent to participate in the study
Exclusion criteria
* Lack of capacity to provide informed consent * Age \< 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extrapulmonary TB: Favourable treatment outcome | December 2040 | Identification of parameters that predict/are significantly associated with favorable outcome in EPTB |
| Drug-resistant TB: Description of treatment outcome | December 2040 | Percentage of patients cured, failed, died, under/after therapy according to WHO and TBnet outcome criteria |
| Drug-resistant TB: Description of treatment completion | December 2040 | Percentage of patients who develop serious/severe drug-related adverse events/who have to change regimen due to drug-related adverse events |
| Drug-susceptible TB: Mortality risk score | December 2040 | Development of a TB mortality risk score, defined by a final set of predictors and a weighted scoring system based on routine clinical, radiological, microbiological, and laboratory data. |
| Therapeutic drug monitoring: Description of Pharmacokinetics | December 2040 | Summary of pharmacokinetic parameters: Mean max/min concentrations, number of patients that are over-/under-/correctly dosed |
Countries
Germany, Italy
Contacts
CONTACTAnca Vasiliu, MD PhD
Outcome results
None listed