EFG Senior - Influenza burden assessment in adults aged of 65 years and more visiting a general practitioner for acute respiratory illness in France 
Head :
Leclerc-Zwirn Christel, Laboratoire GSK
Last update : 01/01/2020 | Version : 1 | ID : 152
| General | |
| Identification | |
| Detailed name | Influenza burden assessment in adults aged of 65 years and more visiting a general practitioner for acute respiratory illness in France |
| Sign or acronym | EFG Senior |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 908370 |
| General Aspects | |
| Medical area |
General practice Infectious diseases Pneumology |
| Others (details) | Influenza |
| Keywords | elderly subjects, epidemiology |
| Scientific investigator(s) (Contact) | |
| Name of the director | Leclerc-Zwirn |
| Surname | Christel |
| Phone | +33 (0)1 39 17 86 96 |
| christel.c.leclerc-zwirn@gsk.com | |
| Unit | Laboratoire GSK |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | GSK laboratory |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | LABORATOIRE GSK |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
An administrative base or a register |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | 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. |
| Database objective | |
| Main objective | 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 |
| Inclusion criteria |
• 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) |
| Population type | |
| Age |
Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2008 |
| Date of last collection (YYYY or MM/YYYY) | 2010 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 93 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Phone interview |
| Biological data (detail) | nasal sample |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | 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. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 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 |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publications are planned |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
