Biological Collection on Emerging Infectious Diseases and Their Treatments (COMETE)
A Biological Sample Collection Established to Support Pathophysiological Research on Emerging and Potentially Emerging Infectious Diseases, as Well as Their Therapeutic Management.
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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Guillaume MARTIN-BLONDEL, MD, PhD
- Numéro de téléphone: 33 +33561779699
- E-mail: martin-blondel.g@chu-toulouse.fr
Sauvegarde des contacts de l'étude
- Nom: Béatrice PIGNOLET, PhD
- Numéro de téléphone: 33 +33561779975
- E-mail: pignolet.b@chu-toulouse.fr
Lieux d'étude
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Toulouse, France, 31059
- University Hospital toulouse
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Contact:
- Guillaume MARTIN-BLONDEL, MD, PhD
- Numéro de téléphone: 33 +33561779699
- E-mail: martin-blondel.g@chu-toulouse.fr
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Contact:
- Béatrice PIGNOLET, PhD
- Numéro de téléphone: 33 +33561779975
- E-mail: pignolet.b@chu-toulouse.fr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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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)
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: through study completion, an average of 1 year
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Prospective collection of all available biological and clinical-biological-imaging data collected during the usual clinical care
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through study completion, an average of 1 year
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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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
Délai: through study completion, an average of 1 year
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Identification of biomarkers using collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
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through study completion, an average of 1 year
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Identify new therapeutic targets for curative or preventive treatments
Délai: through study completion, an average of 1 year
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Identification of therapeutic targets using collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
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through study completion, an average of 1 year
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At the pathogen level: Analyse the biological determinants of the microbe and the resulting infection
Délai: through study completion, an average of 1 year
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Identification of biological determinants of the microbe and the resulting infection using collected biological samples with various methods of screening (PCR, qPCR, sequencing, metagenomics)
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through study completion, an average of 1 year
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At the pathogen level: Develop new tools for identification and characterisation
Délai: through study completion, an average of 1 year
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Use of the biological samples obtained from patients for using new and innovative methods of screening (PCR, qPCR, sequencing, metagenomics)
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through study completion, an average of 1 year
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At the host level: Identification and/or validation of associated or predictive biomarkers
Délai: through study completion, an average of 1 year
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Use of collected biological samples obtained from patients for cohort studies with various methods (flow cytometry, -omics, …)
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through study completion, an average of 1 year
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Guillaume MARTIN-BLONDEL, MD, PhD, University Hospital, Toulouse
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RC31/25/0195
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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