Набор скоро начнётся NCT07674550

Biological Collection on Emerging Infectious Diseases and Their Treatments

— Наблюдательное Emerging Infectious Diseases and Their Treatments

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Emerging Infectious Diseases and Their Treatments. Базовые параметры: 18 лет — 99 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Biological Sample Collection Established to Support Pathophysiological Research on Emerging and Potentially Emerging Infectious Diseases, as Well as Their Therapeutic Management.

Обзор

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

Подробное описание

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.

Первичные конечные точки

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 [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (5)

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 [Срок оценки: through study completion, an average of 1 year]
Identify new therapeutic targets for curative or preventive treatments [Срок оценки: through study completion, an average of 1 year]
At the pathogen level: Analyse the biological determinants of the microbe and the resulting infection [Срок оценки: through study completion, an average of 1 year]
At the pathogen level: Develop new tools for identification and characterisation [Срок оценки: through study completion, an average of 1 year]
At the host level: Identification and/or validation of associated or predictive biomarkers [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

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.