ERAES - Longitudinal study in French Guiana: "Ecology of antibiotic resistance to Escherichia coli and Staphylococcus aureus in the commensal flora"
Head :
Andremont Antoine, EA 6934 RÉSISTANCE BACTÉRIENNE IN VIVO
Last update : 06/03/2015 | Version : 1 | ID : 60128
| General | |
| Identification | |
| Detailed name | Longitudinal study in French Guiana: "Ecology of antibiotic resistance to Escherichia coli and Staphylococcus aureus in the commensal flora" |
| Sign or acronym | ERAES |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | -- |
| General Aspects | |
| Medical area |
Infectious diseases |
| Health determinants |
Medicine |
| Keywords | effect, antibiotics, microorganisms, target bacteria and yeast, commensal flora, ecology, dissemination, health events, prescriptions, progression, environment |
| Scientific investigator(s) (Contact) | |
| Name of the director | Andremont |
| Surname | Antoine |
| Address | 75018 PARIS |
| antoine.andremont@bch.aphp.fr | |
| Unit | EA 6934 RÉSISTANCE BACTÉRIENNE IN VIVO |
| Organization | UNIVERSITÉ PARIS |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Involvement in cohort: neither the ERAES project nor a cohort that is part of a European network. All consortium members are French. However, a Dutch team (PR A. VAN BELKUM, UNIVERSITE ERASME) is involved with the project given its scientific competency in the blind analysis of DNA polymorphism in Amerindians included in the cohort. This association and its procedures were approved by the Bordeaux Ethical Research Committee. |
| Funding | |
| Funding status |
Public |
| Details | ANR, AFSSET, INSERM |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| 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 |
A population file |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Retrospective Other bodies active in creating this cohort: CHU, CHG, Wayampi Amerindians residing in Trois-Sauts (except Guiana) already included in the ERAES AMERINDIENS project. |
| Database objective | |
| Main objective |
General objective: to monitor the changes in bacterial resistance and yeast colonisation in the commensal flora in a cohort of 157 Amerindians living in Trois-Sauts during rapid cultural transition.
Secondary objective: to measure the changes in impact on bacterial resistance and yeast colonisation in the environment (animals, earth, water) during the same period. |
| Inclusion criteria | Adults living in Guiana |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
Departmental |
| French regions covered by the database |
Guyane |
| Detail of the geography area | Guiana |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 10/2006 |
| Date of last collection (YYYY or MM/YYYY) | 06/2012 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 165 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Clinical examination at baseline and during follow-up. Information collected during clinical examination: antibiotic consumption - lifestyle - medical events. Provided by the nurse on duty at Trois-Sauts or the head of the village. |
| Biological data (detail) | Type of samples taken: - cells, nasal swab, saliva. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Blood cells isolated DNA |
| Details of biobank content | DNA bank, collection of bacterial strains |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Interview: input from a paper questionnaire Biological examinations: handwritten |
| Quality procedure(s) used | Request for consistency after data is processed electronically Missing data is managed by returning to source file or third party Subjects contacted again for follow-up visits Internal quality audits carried out during each campaign to obtain samples Patients are informed of the use of their data |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 18 months/2 years |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | Details on database(s) used: health records from village residents kept by the health centre. |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
To be decided if data may be used by academic teams
Access conditions for data use: possible for teams not belonging to a consortium only after project submission and approval by the cohort Scientific Council. Any possible additional analyses on stored samples shall be carried out after Ethical Research Committee approval obtained by the cohort Scientific Committee while preserving the anonymity of those involved. Data may not be used by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
