ITMO public health
Last update : 01/01/2018 | Version : 1 | ID : 161
| General | |
| Identification | |
| Detailed name | General practitioner/paediatrician-based surveillance to estimate the disease burden of rotavirus gastroenteritis in children <5 years of age in France |
| Sign or acronym | SPRIK |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL 770334 |
| General Aspects | |
| Medical area |
Infectious diseases |
| Keywords | general practice, rotavirus |
| 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) |
Not-repeated cross-sectional studies (except case control studies) |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. |
Any child under the age of 5 years from the monitored population who spontaneously consulted an
investigating center for a acute gastroenteritis (defined as the appearance of diarrhea in the 14 previous days) was included in a registry and the study was proposed to the parents of the child or to the child's legal tutors |
| Database objective | |
| Main objective | Estimate the incidence of RVGE leading to a consultation of a general practitioner or pediatrician in a monitored population of children under the age of 5 years. |
| Inclusion criteria | • Any child under the age of 5 years from the monitored population who spontaneously consults an investigating center for a acute gastroenteritis |
| Population type | |
| Age |
Infant (28 days to 2 years) Early childhood (2 to 5 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | European |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2005 |
| Date of last collection (YYYY or MM/YYYY) | 2008 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1463 |
| 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) | Stool sample. Analysis of the presence of rotavirus |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medicines consumption |
| Procedures | |
| Data collection method | Eligibility questionnaire: verification of the eligibility criterion, characteristics of the episode ofgastroenteritis on the day of consultation Inclusion questionnaire: results of the samples with the Rotastrip® test, characteristic of thepatients included, diagnosis and care during the consultation, information on the childrenliving in the same household, antecedents and history of the children included, economicquestionnaire and characteristics of the episode of gastroenteritis before the consultation Telephone questionnaire: medical evaluation of the patients over the 14 days following theconsultation at the doctor's, information on the other children in the household suffering fromgastroenteritis, economic questionnaire Laboratory results: confirmation of the presence of rotavirus, genotyping of the samples |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 14 days after release from the hospital |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.biomedcentral.com/1471-2431/12/58 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | abstract (RICAI 2008), publication in progress |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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