{"doc_desc":{"title":"Longitudinal study in French Guiana: \"Ecology of antibiotic resistance to Escherichia coli and Staphylococcus aureus in the commensal flora\"","idno":"FRESH-PEF60128-en","producers":[{"name":"Antoine ANDREMONT","affiliation":"UNIVERSITE PARIS CITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60128-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60128"},{"agency":"FReSH","code":"FRESH-PEF60128"}]},"title":"Longitudinal study in French Guiana: \"Ecology of antibiotic resistance to Escherichia coli and Staphylococcus aureus in the commensal flora\"","alternate_title":"ERAES"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Antoine;ANDREMONT","PILabo":"UNIVERSIT\u00c9 PARIS \/ EA 6934 R\u00c9SISTANCE BACT\u00c9RIENNE IN VIVO","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"030484073","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"antoine.andremont@gmail.com","isContact":"Yes"}],"oth_id":[{"name":"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.","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261","role":"sponsor id"},{"title":"SIREN","uri":"180036048","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE LA RECHERCHE (ANR)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00rbzpz17"},{"title":"SIREN","uri":"130002504"}]},{"name":"AGENCE NATIONALE DE SECURITE SANITAIRE DE L ALIMENTATION DE L ENVIRONNEMENT ET DU TRAVAIL (ANSES)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0471kz689"},{"title":"SIREN","uri":"130012024"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]}]},"distribution_statement":{"contact":[{"name":"Antoine;ANDREMONT","email":"antoine.andremont@gmail.com","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"effect"},{"keyword":"antibiotics"},{"keyword":"microorganisms"},{"keyword":"target bacteria and yeast"},{"keyword":"commensal flora"},{"keyword":"ecology"},{"keyword":"dissemination"},{"keyword":"health events"},{"keyword":"prescriptions"},{"keyword":"progression"},{"keyword":"environment"}],"topics":[{"topic":"Infectious disease medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"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.","abstract":"","coll_dates":[{"start":"2006-01-01","end":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Guyane']","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"General population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Adults living in Guiana\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['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']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Population database for statistical purposes']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"165"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"To be decided if data may be used by academic teams Data may not be used by industrial teams.","conditions":"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.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"08-05-2015","isContributorPI":"No","contributorName":"Antoine ANDREMONT","contributorAffiliation":"UNIVERSITE PARIS CITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"Liste des publications dans Pubmed","link":"http:\/\/tinyurl.com\/PUBMED-ERAES"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Public (France)"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Interview: input from a paper questionnaire Biological examinations: handwritten","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Guiana"},"dataTypes":{"clinicalDataDetails":"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.","biologicalDataDetails":"Type of samples taken: - cells, nasal swab, saliva.","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}