Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-03-26 @ 4:12 PM
Study NCT ID:
NCT02868658
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2016-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Asymptomatic Flu Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 289}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2016-08-11', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of influenza cases', 'timeFrame': '6 months after inclusion', 'description': 'Incidence of asymptomatic and symptomatic influenza per 1000 days at risk among healthcare workers'}], 'secondaryOutcomes': [{'measure': 'Fraction of asymptomatic influenza cases', 'timeFrame': '6 months after inclusion', 'description': 'Fraction of asymptomatic influenza cases among patients with confirmed influenza infection (seroconversion)'}, {'measure': 'Stratified incidence ratios', 'timeFrame': '6 months after inclusion', 'description': 'The objective is to compare the proportion of asymptomatic influenza among vaccinated and unvaccinated healthcare workers, stratified on the type of influenza virus , gender, age, and other covariates'}, {'measure': 'Incidence of influenza-like illness', 'timeFrame': '6 months after inclusion', 'description': 'The objective is to calculate the incidence of influenza-like illness without virological confirmation'}, {'measure': 'proportion of health-care workers with Influenza vaccine coverage', 'timeFrame': '6 months after inclusion', 'description': 'The objective is to estimate the vaccination coverage against influenza among health care workers'}, {'measure': 'Number of sick-leave days per participating ward', 'timeFrame': '6 months after inclusion', 'description': 'The objective is to estimate the professional impact of influenza in a population of healthcare workers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Influenza', 'health care workers', 'nosocomial', 'asymptomatic', 'France'], 'conditions': ['Influenza']}, 'referencesModule': {'references': [{'pmid': '32750120', 'type': 'RESULT', 'citation': 'Benet T, Amour S, Valette M, Saadatian-Elahi M, Aho-Glele LS, Berthelot P, Denis MA, Grando J, Landelle C, Astruc K, Paris A, Pillet S, Lina B, Vanhems P; AFP Study Group. Incidence of Asymptomatic and Symptomatic Influenza Among Healthcare Workers: A Multicenter Prospective Cohort Study. Clin Infect Dis. 2021 May 4;72(9):e311-e318. doi: 10.1093/cid/ciaa1109.'}]}, 'descriptionModule': {'briefSummary': 'Although clinical presentation of influenza is often symptomatic, asymptomatic cases also occur. The knowledge of the incidence of asymptomatic influenza among healthcare workers is very important because of the risk of cross-transmission to hospitalized patients. The principal objective of the study is to estimate the incidence of symptomatic and asymptomatic influenza among healthcare workers in short-stay wards. The results of this study will lead to a better understanding of the burden of asymptomatic influenza among healthcare workers and might be used as an argument to increase influenza vaccine coverage among healthcare workers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteer health-care workers\n* Working in the following wards: short-stay, inpatient (including ICU) and emergency\n\nExclusion Criteria:\n\n* Presence of influenza symptoms at enrolment\n* Programmed absence (maternity leave, vacation, etc.)\n* Administrative agents'}, 'identificationModule': {'nctId': 'NCT02868658', 'acronym': 'AFP', 'briefTitle': 'Asymptomatic Flu Project', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Incidence of Symptomatic and Asymptomatic Influenza Among Healthcare Workers : A Multicenter Cohort Study', 'orgStudyIdInfo': {'id': '69HCL16_0095'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health-care workers', 'description': 'Health-care workers recruited in the study will have blood sampling and naso-pharyngeal bottle-brush sampling', 'interventionNames': ['Biological: Blood sampling', 'Other: Nasal swab']}], 'interventions': [{'name': 'Blood sampling', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Health-care workers']}, {'name': 'Nasal swab', 'type': 'OTHER', 'armGroupLabels': ['Health-care workers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Edouard Herriot Hospital; Department of Epidemiology, Hygiene and Public Health', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}