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| Name | Class |
|---|---|
| European Society of Clinical Microbiology and Infectious Diseases | OTHER |
| Tuberculosis Network European Trialsgroup (TBnet e.V.) | UNKNOWN |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extrapulmonary TB | Individuals affected by extrapulmonary tuberculosis |
| |
| drug-resistant TB | Individuals affected by rifampicin- and higher-resistant tuberculosis |
| |
| drug-susceptible TB | Individuals affected by rifampicin-susceptible tuberculosis |
| |
| TDM | Individuals under anti-tuberculosis treatment with an indication for therapeutic drug monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| data collection | Other | Prospective data collection in a clinical data registry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Extrapulmonary TB: Favourable treatment outcome | Identification of parameters that predict/are significantly associated with favorable outcome in EPTB | December 2040 |
| Drug-resistant TB: Description of treatment outcome | Percentage of patients cured, failed, died, under/after therapy according to WHO and TBnet outcome criteria | December 2040 |
| Drug-resistant TB: Description of treatment completion | Percentage of patients who develop serious/severe drug-related adverse events/who have to change regimen due to drug-related adverse events | December 2040 |
| Drug-susceptible TB: Mortality risk score | 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. | December 2040 |
| Therapeutic drug monitoring: Description of Pharmacokinetics | Summary of pharmacokinetic parameters: Mean max/min concentrations, number of patients that are over-/under-/correctly dosed | December 2040 |
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Inclusion Criteria:
Exclusion Criteria:
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Inpatients in tuberculosis care
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anca Vasiliu, MD PhD | Contact | +49 4537 188 8080 | tbnetregistry@fz-borstel.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Center Borstel, Leibniz Lung Center | Borstel | Schleswig-Holstein | 23845 | Germany |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D000092225 | Tuberculosis, Extrapulmonary |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| IRCCS Ospedale Sacro Cuore Don Calabria | Negrar | Verona | 37024 | Italy |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |