ITMO Santé Publique
ITMO Santé Publique
Date de modification : 01/01/2020 | Version : 1 | ID : 152
| Général | |
| Identification | |
| Nom détaillé | Influenza burden assessment in adults aged of 65 years and more visiting a general practitioner for acute respiratory illness in France |
| Sigle ou acronyme | EFG Senior |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CNIL : 908370 |
| Thématiques générales | |
| Domaine médical |
General practice Infectious diseases Pneumology |
| Autres, précisions | Influenza |
| Mots-clés | elderly subjects, epidemiology |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Leclerc-Zwirn |
| Prénom | Christel |
| Téléphone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Laboratoire | Laboratoire GSK |
| Collaborations | |
| Financements | |
| Financements |
Private |
| Précisions | GSK laboratory |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | LABORATOIRE GSK |
| Statut de l’organisation |
Secteur Privé |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Longitudinal study (except cohorts) |
| Origine du recrutement des participants |
An administrative base or a register |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Informations complémentaires concernant la constitution de l'échantillon | All of the general practitioners in the GROG network monitoring the age group of patients aged 65 years and older can participate. Each investigator will have to include, during the entire epidemic period (equivalent to the period of inclusion), the first 7 patients that meet the eligibility criteria. |
| Objectif de la base de données | |
| Objectif principal | Describe and compare the burden of acute respiratory infections (IRA) linked to influenza virus, in terms of morbidity and medical consumption, according to the vaccinal status, in those 65 years and older spontaneously consulting in general practice |
| Critères d'inclusion |
• Patient aged 65 years or older • Patient having an acute respiratory infection defined as a clinical presentation combining the abrupt appearance of respiratory signs (coughing, rhinitis, coryza) in the context of acute infection (fever, asthenia, headache, myalgia, etc.), in less than 48h. • For patients 80 years and older, the clinical presentations can associate other general signs (mental confusion, dehydration, anorexia, digestive disorders, general malaise, body aches, headache) and respiratory signs (from rhinitis to pneumopathy) |
| Type de population | |
| Age |
Elderly (65 to 79 years) Great age (80 years and more) |
| Population concernée |
Sick population |
| Sexe |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | France |
| Collecte | |
| Dates | |
| Année du premier recueil | 2008 |
| Année du dernier recueil | 2010 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
< 500 individuals |
| Détail du nombre d'individus | 93 |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data Declarative data Biological data |
| Données cliniques, précisions |
Direct physical measures Medical registration |
| Données déclaratives, précisions |
Paper self-questionnaire Phone interview |
| Données biologiques, précisions | nasal sample |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health event/morbidity Health care consumption and services |
| Consommation de soins, précisions |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Modalités | |
| Mode de recueil des données | Each investigator will have to include, during the entire epidemic period (equivalent to the period of inclusion), the first 7 patients that meet the eligibility criteria. The investigator will inform patients who have accepted the study, of the objectives of the study using the information notice and will have them sign an explicit consent form. He will then complete the doctor's inclusion questionnaire and will remit the follow-up logbook to the patient, explaining to the latter how to complete this logbook. He must notify the logistics center of the inclusion via fax. The investigator will take a nasal sample and will send it to the reference laboratory according to the study's sampling protocol. In order to control any bias in the selection of patients, a non-inclusion registry will be set up. The investigating doctor will be asked to complete this registry, for all of the patients that meet the eligibility criteria who are not included in the cohort and to fill in the reason for non-inclusion, whatever it may be. |
| Suivi des participants |
Yes |
| Détail du suivi | Patient follow-up will take place by telephone (or during a visit) between 7 and 10 days and between 28 and 31 days after the inclusion visit, by the investigator, regardless of the patient's vaccinal status and the result of the virological tests. A questionnaire at the end of the study will also be completed by the investigator at the end of the period of the epidemic period, in order to follow any complications and/or superinfections linked to the influenza, and to inform the patients who have left the study. As for the patients, they will, starting on the day of their inclusion in the study, a follow-up logbook until they are cured or up to 28 days |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) | Publications are planned |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
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