Biological Collection on Emerging Infectious Diseases and Their Treatments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Emerging Infectious Diseases and Their Treatments. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Biological Sample Collection Established to Support Pathophysiological Research on Emerging and Potentially Emerging Infectious Diseases, as Well as Their Therapeutic Management.
Overview
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
Detailed description
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.
Primary outcome measures
- 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 [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (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 [Time frame: through study completion, an average of 1 year]
- Identify new therapeutic targets for curative or preventive treatments [Time frame: through study completion, an average of 1 year]
- At the pathogen level: Analyse the biological determinants of the microbe and the resulting infection [Time frame: through study completion, an average of 1 year]
- At the pathogen level: Develop new tools for identification and characterisation [Time frame: through study completion, an average of 1 year]
- At the host level: Identification and/or validation of associated or predictive biomarkers [Time frame: through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
\- Patients under a legal guardianship arrangement (guardianship, curatorship or court-ordered guardianship)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- University Hospital Toulouse — Toulouse
Identifiers
NCT: NCT07674550 · RC31/25/0195