Tuberculosis Clinical Registry in Europe
2026年6月24日 更新者：Anca Vasiliu、Research Center Borstel
Tuberculosis Clinical Registry in Europe - the TBnet Registry
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.
研究概览
详细说明
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).
研究类型
观察性的
注册 (估计的)
1000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Anca Vasiliu, MD PhD
- 电话号码：+49 4537 188 8080
- 邮箱：tbnetregistry@fz-borstel.de
学习地点
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Schleswig-Holstein
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Borstel、Schleswig-Holstein、德国、23845
- Research Center Borstel, Leibniz Lung Center
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接触：
- Anca Vasiliu, MD PhD
- 电话号码：+49 4537 188 8080
- 邮箱：tbnetregistry@fz-borstel.de
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-
-
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Verona
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Negrar、Verona、意大利、37024
- IRCCS Ospedale Sacro Cuore Don Calabria
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接触：
- Lorenzo Guglielmetti, MD PhD
- 电话号码：+39 0456013111
- 邮箱：tbnetregistry@fz-borstel.de
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Inpatients in tuberculosis care
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Extrapulmonary TB
Individuals affected by extrapulmonary tuberculosis
|
Prospective data collection in a clinical data registry
|
|
drug-resistant TB
Individuals affected by rifampicin- and higher-resistant tuberculosis
|
Prospective data collection in a clinical data registry
|
|
drug-susceptible TB
Individuals affected by rifampicin-susceptible tuberculosis
|
Prospective data collection in a clinical data registry
|
|
TDM
Individuals under anti-tuberculosis treatment with an indication for therapeutic drug monitoring
|
Prospective data collection in a clinical data registry
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Extrapulmonary TB: Favourable treatment outcome
大体时间：December 2040
|
Identification of parameters that predict/are significantly associated with favorable outcome in EPTB
|
December 2040
|
|
Drug-resistant TB: Description of treatment outcome
大体时间：December 2040
|
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
大体时间：December 2040
|
Percentage of patients who develop serious/severe drug-related adverse events/who have to change regimen due to drug-related adverse events
|
December 2040
|
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Drug-susceptible TB: Mortality risk score
大体时间：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.
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December 2040
|
|
Therapeutic drug monitoring: Description of Pharmacokinetics
大体时间：December 2040
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Summary of pharmacokinetic parameters: Mean max/min concentrations, number of patients that are over-/under-/correctly dosed
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December 2040
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2040年12月1日
研究完成 (估计的)
2040年12月1日
研究注册日期
首次提交
2026年6月24日
首先提交符合 QC 标准的
2026年6月24日
首次发布 (实际的)
2026年7月1日
研究记录更新
最后更新发布 (实际的)
2026年7月1日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.