Tuberculosis Clinical Registry in Europe - the TBnet Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Extrapulmonary TB: Favourable treatment outcome
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Tuberculosis
- •Age ≥ 18 years
- •Capacity to provide informed consent
- •Written informed consent to participate in the study
排除标准
- •Lack of capacity to provide informed consent
- •Age < 18 years
结局指标
主要结局
Extrapulmonary TB: Favourable treatment outcome
时间窗: December 2040
Identification of parameters that predict/are significantly associated with favorable outcome in EPTB
Drug-resistant TB: Description of treatment outcome
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: December 2040
Summary of pharmacokinetic parameters: Mean max/min concentrations, number of patients that are over-/under-/correctly dosed
次要结局
未报告次要终点
研究者
Anca Vasiliu
Anca Vasiliu MD PhD
Research Center Borstel
