A Biological Sample Collection Established to Support Pathophysiological Research on Emerging and Potentially Emerging Infectious Diseases, as Well as Their Therapeutic Management.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5,300
- 试验地点
- 1
- 主要终点
- Collection of biological samples and associated data from patients at risk of acquiring, or affected by, emerging or potentially emerging infectious diseases, including those receiving preventive or curative treatment for such infections
研究概览
简要总结
Unprecedented changes in human-environment interactions and increasing disruptions to ecosystems and the climate have contributed to the emergence of infectious diseases (Emerging Infectious Diseases, EIDs). Advances in the treatment of cancers, malignant haematological disorders and immune-mediated inflammatory diseases are also contributing to the creation of new infectious risks among immunocompromised patient populations.
The COVID-19 pandemic has shown that structuring research prior to any outbreak is essential for the rapid implementation of responses to the emergence of an EID. The unpredictability of an EID's occurrence necessitates the planning of research projects in advance. A key element in this planning is the development of a collection of biological samples, providing a structured and immediately deployable resource for conducting pathophysiological and therapeutic research aimed at:
- Analyze the biological determinants of the microbe and the resulting infection
- Develop new tools for identification and characterization
- Study the factors (biomarkers/signatures) associated with individual patient susceptibility and response to treatment (personalized medicine)
- Understand the pathophysiology of infection to identify new targets for diagnostic, curative and preventive treatment
- Monitor the efficacy of curative and preventive treatments
详细描述
COMETE consists in a prospective monocenter longitudinal non-interventional study allowing the collection of biological samples from individuals or patients investigated in the context of an emerging infectious disease or one at risk of emergence due to exposure or suggestive symptomatology, whether the infection is ultimately ruled out or confirmed, and whether or not they have received curative or preventive treatment for this infection.
Visits: The initial visit (inclusion) and follow-up visits will take place as part of the patient's routine care, assessing their disease status or the curative or preventive treatment received during either hospitalization or a consultation. During these visits, biological samples will be collected when sampling is planned as part of the care (for verification, suspicion, diagnosis, or monitoring), and then throughout the follow-up period as part of the care plan.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or over
- •Patients or individuals who have been exposed, are at risk of exposure, or are at risk of complications if exposed, or who are suspected of having, or are diagnosed with, an infectious disease considered to be emerging or at risk of emerging
- •Patients receiving, or likely to receive, innovative treatments for the infection (new therapeutic molecules, checkpoint inhibitors, cell therapies, etc.)
- •Patients or individuals receiving, or likely to receive, vaccines or other preventive therapeutic strategies
- •Pregnant and breastfeeding women may be included.
排除标准
- •- Patients under a legal guardianship arrangement (guardianship, curatorship or court-ordered guardianship)
研究组 & 干预措施
Subjects presenting with emerging or potentially emerging infectious diseases
Biological samples will be collected in the normal diagnosis and follow-up process (only blood will be collected in larger quantity)
结局指标
主要结局
Collection of biological samples and associated data from patients at risk of acquiring, or affected by, emerging or potentially emerging infectious diseases, including those receiving preventive or curative treatment for such infections
时间窗: through study completion, an average of 1 year
Prospective collection of all available biological and clinical-biological-imaging data collected during the usual clinical care
次要结局
- To improve our understanding of the pathophysiology of infection in order to identify new biomarkers for diagnostic and prognostic purposes, with a view to improving the management of emerging infectious diseases or those at risk of emerging(through study completion, an average of 1 year)
- Identify new therapeutic targets for curative or preventive treatments(through study completion, an average of 1 year)
- At the pathogen level: Analyse the biological determinants of the microbe and the resulting infection(through study completion, an average of 1 year)
- At the pathogen level: Develop new tools for identification and characterisation(through study completion, an average of 1 year)
- At the host level: Identification and/or validation of associated or predictive biomarkers(through study completion, an average of 1 year)