- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03010007
Prospective Analysis of Seasonal Influenza - Viral Transmission and Evolution in the City of Basel, Switzerland
Prospective Analysis of Seasonal Influenza - Viral Transmission and Evolution in the City of Basel, Switzerland [Prospektive Systemanalyse Der Saisonalen Influenza - Virustransmission Und Evolution in Der Stadt Basel] in German
Influenza associated illness has a global annual impact with high morbidity and mortality. Transmission mechanisms and rates are under-investigated and overall poorly understood.
This project aims to use epidemiological tools to understand the transmission and evolution of influenza viruses at an individual and population level within a small-scale city (Basel) through a combination of experimental, clinical and mathematical advances. The investigators aim to quantitatively characterize the viral transmission using novel molecular-epidemiological tools based on whole genome sequencing.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
In this prospective observational study, paediatric and adult outpatients presenting with influenza-like illness will be enrolled at the emergency departments of the University Hospital Basel (USB), the paediatric University Hospital of both Basel (UKBB), or a network of family doctors (associated with Center of Primary Health Care).
The Clinical Trial Unit at the University Hospital Basel will coordinated the recruitment process, collect data and sample all patients during the influenza season 2016/17. Samples will be collected such as whole blood, serum and DNA, nasopharyngeal swamps to diagnose influenza by polymerase chain reaction (PCR) assay and to determine colonization rates with Staphylococcus aureus and Streptococcus pneumonia. All samples except the first naso-pharyngeal swab for influenza diagnostics will be stored in a biobank and analysed in batches. Each influenza virus isolate will be sequenced using a "whole genome sequencing" approach. The viral transmission and evolution will be analysed using whole genome data for a detailed molecular and phylogenetic tree analysis, respectively. The epidemiological and geographical data will be incorporated into the phylogenetic model.
Specific aims are:
(i) to determine the impact of the most important epidemiological parameters, first focusing on the age profile, followed by children per house hold, and population density, on influenza transmission at an individual and population level, drawing on an analysis of baseline humoral immunity and whole genome sequencing data, (ii) to understand the viral evolution during seasonal epidemics, (iii) to develop dynamic mathematical models that are able to predict viral transmission and evolution based on the retrospective results from (i) and (ii) and to validate this model in future influenza seasons.
To realize the interdisciplinary approach, the investigators will rely on the expertise in mathematical modelling of viral epidemiology and evolution and established geographical expertise, next generation sequencing, clinical epidemiology, and immunologic diagnostic techniques.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Basel, Suisse, 4031
- University Hospital Basel
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Basel, Suisse, 4031
- Federal Institute of Technology Zurich
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Basel, Suisse, 4031
- University Children's Hospital
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Basel, Suisse, 4031
- Universitätres Zentrum für Hausarztmedizin beider Basel, University of Basel
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Each pediatric or adult patient, which fulfill the Worl Health Organization (WHO) definition of Influenza like illness.
- The case definition includes an acute respiratory infection with coughing, fever ≥38°C, and start of symptoms within the last 10 days.
- Presentation of the patient with influenza-like illness on the emergency ward of the University Hospital Basel or the University Children Hospital of both Basel or a collaborating private practise.
- Patient has to live in the city of Basel.
Exclusion Criteria:
- Patients who are not living in the City of Basel.
- Case definition for influenza like illness is not fulfilled.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Investigation of the phylogenetic relation of viral isolates from participating patients using whole-genome sequencing and bioinformatics
Délai: Baseline
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The primary microbiological endpoint is the connection of two viral isolates via comparison and phylogenetic analysis by using the genetic information
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Baseline
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Adrian Egli, PD Dr. FAMH, Clinical Microbiology, University Hospital Basel
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Influenza in Basel 2016/2017
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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