Establishment of a Biobank for the Evaluation of Rapid Diagnostic Solutions for Emerging Infectious Diseases and CBRN Threats - DiagRaMIE Biobanque
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Number of residual clinical samples successfully collected, aliquoted, and stored with associated clinical and microbiological data
研究概览
简要总结
This multicenter prospective registry aims to establish a biobank of residual biological samples and associated clinical data from hospitalized patients. The registry will collect a wide range of specimens (serum, plasma, respiratory samples, urine, cerebrospinal fluid, biopsies) obtained during routine care, without any additional procedures. Data are pseudonymized and stored securely for up to 20 years. The biobank will be used to develop and evaluate rapid diagnostic tests (RDTs) for emerging infectious diseases and CBRN threats to improve epidemic preparedness and patient management.
详细描述
The DiagRaMIE Biobank is designed to support the national strategy for emerging infectious diseases and CBRN (Chemical, Biological, Radiological, Nuclear) threats. Over a 3-year inclusion period, residual samples from routine care (e.g., blood, plasma, urine, cerebrospinal fluid, respiratory specimens, biopsies) will be systematically collected from eligible hospitalized patients in Bicêtre and Paul Brousse hospitals. Associated demographic, clinical, and microbiological data will be recorded in a secure electronic case report form (eCRF) and pseudonymized.
No additional procedures, visits, or interventions are required for participants. The biobank will provide a sustainable source of high-quality biological material and standardized data to enable the development, validation, and rapid deployment of in vitro rapid diagnostic tests (RDTs) targeting pathogens of major public health concern, including those prioritized by WHO (e.g., Yersinia pestis, Candida auris, Francisella tularensis, MERS-CoV, Nipah virus, Crimean-Congo hemorrhagic fever virus). This initiative aims to strengthen epidemic surveillance and preparedness and to ensure timely diagnostic capacity in future public health crises.
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
- •Adults (≥ 18 years old) hospitalized in one of the participating centers at Bicêtre or Paul Brousse hospitals, for whom residual biological samples are available as part of routine care in one or more participating hospital departments.
- •Covered by, or entitled to, the French social security system (excluding State Medical Aid - AME).
- •Patient or legal representative/trusted person informed about the registry and having provided written consent to participate.
排除标准
- •Patients under judicial protection (guardianship or curatorship).
- •Patients deprived of liberty by judicial or administrative decision.
- •Patients not speaking French and not accompanied by a translator.
结局指标
主要结局
Number of residual clinical samples successfully collected, aliquoted, and stored with associated clinical and microbiological data
时间窗: 36months (end of patient inclusion period)
Creation of a collection of residual biological samples (serum, plasma, urine, respiratory samples, CSF, biopsies, etc.) and associated clinical and microbiological data obtained during routine care
次要结局
未报告次要终点