{"doc_desc":{"title":"\u00c9tude multicentrique sur la transmission nosocomiale du virus SARS-CoV2","idno":"FRESH-PEF73991-fr","producers":[{"name":"PHILIPPE VANHEMS","affiliation":"UNIVERSITE CLAUDE BERNARD LYON 1"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73991-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73991"},{"agency":"FReSH","code":"FRESH-PEF73991"},{"agency":"NCT","code":"NCT04290780"}]},"title":"\u00c9tude multicentrique sur la transmission nosocomiale du virus SARS-CoV2","alternate_title":"NOSO-COR Project"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Philippe;VANHEMS","firstname":"Philippe","lastname":"VANHEMS","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/029brtt94","role":"organisation id"},{"title":"SIREN","uri":"196917744","role":"organisation id"}],"email":"philippe.vanhems@chu-lyon.fr","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","PILabo":"Centre International de Recherche en Infectiologie (CIRI), INSERM U1111, CNRS, UMR5308, ENS de Lyon, UCBL1, Lyon, France \/ Centre Hospitalier H\u00f4pital Edouard Herriot \u2013 Hospices Civils de Lyon \/ Laboratoire des Pathog\u00e8nes Emergents, Fondation M\u00e9rieux, \/ Service Hygi\u00e8ne, Epid\u00e9miologie et Pr\u00e9vention","isContact":true}],"oth_id":[{"name":"Fondation M\u00e9rieux-R\u00e9seau GABRIEL, I-MOVE-COVID-19","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"HOSPICES CIVILS DE LYON (HCL)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01502ca60","role":"sponsor id"},{"title":"SIREN","uri":"266900273","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"BILL & MELINDA GATES FOUNDATION-BMGF","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/0456r8d26"}]},{"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":"Philippe;VANHEMS","lastname":"VANHEMS","firstname":"Philippe","type":"contact","email":"philippe.vanhems@chu-lyon.fr","affiliationName":"UNIVERSITE CLAUDE BERNARD LYON 1","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/029brtt94","role":"organisation id","title":"ROR"},{"uri":"196917744","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"infections nosocomiales"},{"keyword":"Covid-19"}],"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":"Certaines maladies infectieuses ou parasitaires","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1435254666","title":"CIM-11"}]},{"topic":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]},{"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":"D\u00e9crire et documenter les cas suspect\u00e9s ou confirm\u00e9s d'infections nosocomiales par le SRAS-CoV2, leur spectre clinique et les d\u00e9terminants (facteurs de risque \/ protection) dans les h\u00f4pitaux participants.","abstract":"","coll_dates":[{"start":"2020-01-01","end":"2020-12-31"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Madagascar","abbreviation":"mg","extLink":{"vocab":"ISO","vocabURI":"mg"}},{"name":"C\u00f4te d'Ivoire","abbreviation":"ci","extLink":{"vocab":"ISO","vocabURI":"ci"}},{"name":"Mali","abbreviation":"ml","extLink":{"vocab":"ISO","vocabURI":"ml"}},{"name":"Guin\u00e9e","abbreviation":"gn","extLink":{"vocab":"ISO","vocabURI":"gn"}},{"name":"Bangladesh","abbreviation":"bd","extLink":{"vocab":"ISO","vocabURI":"bd"}},{"name":"Liban","abbreviation":"lb","extLink":{"vocab":"ISO","vocabURI":"lb"}}],"geog_coverage":"","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\": \"Nourrisson (28j \u00e0 2 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D007223\"\n            }\n        },\n        {\n            \"value\": \"Petite enfance (2 \u00e0 5 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002675\"\n            }\n        },\n        {\n            \"value\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\n        {\n            \"value\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Tout adulte ou enfant volontaire ou tout membre du personnel soignant de l'h\u00f4pital participant \u00e0 l'\u00e9tude qui pr\u00e9sente un syndrome infectieux r\u00e9pondant aux d\u00e9finitions suivantes et dont le consentement \u00e9clair\u00e9 oral\\\/\u00e9crit a \u00e9t\u00e9 obtenu des parents\\\/tuteurs pour les enfants de moins de 18 ans. (selon les exigences \u00e9thiques de chaque site participant).  D\u00e9finitions Cas suspect : - Fi\u00e8vre sup\u00e9rieure \u00e0 37,8 \u00b0C en l'absence d'antipyr\u00e9tiques ; et ou - Toux ou douleur pharyng\u00e9e ou autre sympt\u00f4me \u00e9voquant une infection respiratoire. ET au moins 1 des caract\u00e9ristiques suivantes : - retour d'un voyage en Chine, ou d'un pays dans lequel l'augmentation de l'incidence des infections au SRAS-CoV2 a \u00e9t\u00e9 prouv\u00e9e ; - contact \u00e9troit (partage du m\u00eame lieu de vie familiale, professionnelle, du m\u00eame avion, etc.) avec une personne d\u00e9finie comme cas suspect ou confirm\u00e9 ; - survenue dans un h\u00f4pital ayant accueilli au moins un cas suspect ou confirm\u00e9 d'infection \u00e0 SRAS-CoV2.  Cas confirm\u00e9 - Les m\u00eames d\u00e9finitions cliniques, auxquelles s'ajoute un r\u00e9sultat positif du diagnostic virologique de type RT-PCR sp\u00e9cifique au SRAS-CoV2.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es paracliniques','Donn\u00e9es biologiques','Donn\u00e9es socio-d\u00e9mographiques','Donn\u00e9es comportementales']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\r\nConsommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Base m\u00e9dico-administrative"]}],"target_sample_size":"[1000-10000[ individus","response_rate":"3221"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"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":"","conditions":"","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":"10-03-2021","lastUpdatedAuto":null,"lastUpdatedManual":"07-07-2025","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Protocol for a prospective, observational, hospital-based multicentre study of nosocomial SARS-CoV-2 transmission: NOSO-COR Project","link":"https:\/\/bmjopen.bmj.com\/content\/10\/10\/e039088.long"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Priv\u00e9 \u00e0 but non lucratif","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":false},"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":"Dans cette \u00e9tude prospective, les donn\u00e9es proviennent du dossier m\u00e9dical du patient. Les professionnels de sant\u00e9 ont \u00e9t\u00e9 contact\u00e9s par t\u00e9l\u00e9phone pour r\u00e9pondre aux questions.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":true},"geographicalCoverage":{"geoDetail":"France, Madagascar, C\u00f4te d'Ivoire, Mali, Guin\u00e9e, Bangladesh, Liban"},"dataTypes":{"clinicalDataDetails":"Sympt\u00f4mes, admission en soins intensifs, ventilation, complications, dur\u00e9e du s\u00e9jour","biologicalDataDetails":"test virologique, formule sanguine compl\u00e8te, param\u00e8tres biochimiques","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}