{"doc_desc":{"title":"Etude longitudinale en Guyane: \"\u00c9cologie de la r\u00e9sistance aux antibiotiques de Escherichia coli et Staphylococcus aureus dans les flores commensales\"","idno":"FRESH-PEF60128-fr","producers":[{"name":"Antoine ANDREMONT","affiliation":"UNIVERSITE PARIS CITE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60128-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60128"},{"agency":"FReSH","code":"FRESH-PEF60128"}]},"title":"Etude longitudinale en Guyane: \"\u00c9cologie de la r\u00e9sistance aux antibiotiques de Escherichia coli et Staphylococcus aureus dans les flores commensales\"","alternate_title":"ERAES"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Antoine;ANDREMONT","firstname":"Antoine","lastname":"ANDREMONT","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/05f82e368","role":"organisation id"},{"title":"SIREN","uri":"130025737","role":"organisation id"}],"email":"antoine.andremont@gmail.com","affiliationName":"UNIVERSITE PARIS CITE","PILabo":"UNIVERSIT\u00c9 PARIS \/ EA 6934 R\u00c9SISTANCE BACT\u00c9RIENNE IN VIVO","isContact":true}],"oth_id":[{"name":"Implication dans un r\u00e9seau de cohorte : ni le projet ERAES ni la cohorte ne font partie d'un r\u00e9seau europ\u00e9en. Les membres du consortium sont tous fran\u00e7ais. N\u00e9anmoins, une \u00e9quipe n\u00e9erlandaise (PR. A. VAN BELKUM, UNIVERSITE ERASME) est associ\u00e9e au projet en raison de ces comp\u00e9tences scientifiques pour l'analyse en aveugle du polymorphisme de l'ADN des am\u00e9rindiens inclus dans la cohortes. Cette association et ses modalit\u00e9s ont re\u00e7u l'accord du CPP de Bordeaux.","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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","lastname":"ANDREMONT","firstname":"Antoine","type":"contact","email":"antoine.andremont@gmail.com","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":"effet"},{"keyword":"antibiotiques"},{"keyword":"microorganismes"},{"keyword":"bact\u00e9ries cibles et levures"},{"keyword":"flores commensales"},{"keyword":"\u00e9cologie"},{"keyword":"diss\u00e9mination"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"prescriptions"},{"keyword":"\u00e9volution"},{"keyword":"environnement"}],"topics":[{"topic":"Infectiologie","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":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : surveiller l\u2019\u00e9volution de la r\u00e9sistance bact\u00e9rienne et de la colonisation \u00e0 levures dans les flores commensales d\u2019une cohorte de 157 am\u00e9rindiens vivants \u00e0 Trois-Sauts au moment d\u2019une transition culturelle rapide. Objectif secondaire : mesurer l\u2019\u00e9volution de l\u2019impact sur la r\u00e9sistance bact\u00e9rienne et la colonisation \u00e0 levures dans l\u2019environnement (animaux, sols, eaux) au cours de la m\u00eame p\u00e9riode.","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":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\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\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Adultes r\u00e9sidant en Guyane\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques Gestion des donn\u00e9es manquantes par retour vers un tiersRelance des sujets pour r\u00e9aliser les visites de suiviR\u00e9alisation d\\'audits qualit\u00e9 internes \u00e0 chaque campagne de pr\u00e9l\u00e8vements Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Base de population \u00e0 finalit\u00e9 statistique']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"< 500 individus","response_rate":"165"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques : \u00e0 d\u00e9terminer Utilisation non possible des donn\u00e9es par des industriels","conditions":"Condition d&#x27;acc\u00e8s l\u2019utilisation des donn\u00e9es : sera possible pour des \u00e9quipes n\u2019appartenant pas au consortium uniquement apr\u00e8s soumission de projets et validation par le conseil scientifique de la cohorte. Dans tous les cas ces \u00e9ventuelles analyses compl\u00e9mentaires sur des pr\u00e9l\u00e8vements stockes seront r\u00e9alis\u00e9es apr\u00e8s accord du CPP saisi par le comit\u00e9 scientifique de la cohorte et dans le respect strict de l\u2019anonymat des participants.","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"08-05-2015","isContributorPI":false,"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":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier Examens biologiques : \u00e9tape manuscrite","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Guyane"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi.Informations recueillies lors de l'examen clinique : consommation antibiotique - mode de vie - \u00e9v\u00e9nements m\u00e9dicaux. renseign\u00e9s par l'infirmier en poste a trois-sauts, ou le chef de village","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : -selles, \u00e9couvillon nasal, salive.","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}