Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-11 @ 3:27 AM
Study NCT ID:
NCT02910856
Status:
COMPLETED
Last Update Posted:
2024-01-08
First Post:
2016-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Infective Endocarditis in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004696', 'term': 'Endocarditis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2017-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2016-08-25', 'studyFirstSubmitQcDate': '2016-09-21', 'lastUpdatePostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline geriatric characteristics at 3 months', 'timeFrame': '3 months after inclusion', 'description': 'OMS score'}], 'secondaryOutcomes': [{'measure': 'Three months mortality', 'timeFrame': '3 months after inclusion', 'description': 'Mortality rate at 3 months'}, {'measure': 'One year mortality', 'timeFrame': '1 year after inclusion', 'description': 'Mortality rate at 1 year'}, {'measure': 'Change from baseline geriatric characteristics at 3 months', 'timeFrame': '3 months after inclusion', 'description': "Karnofsky'score"}, {'measure': 'Change from baseline geriatric characteristics at 3 months', 'timeFrame': '3 months after inclusion', 'description': 'Score MNA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infective Endocarditis']}, 'referencesModule': {'references': [{'pmid': '27621607', 'type': 'RESULT', 'citation': 'Forestier E, Fraisse T, Roubaud-Baudron C, Selton-Suty C, Pagani L. Managing infective endocarditis in the elderly: new issues for an old disease. Clin Interv Aging. 2016 Sep 2;11:1199-206. doi: 10.2147/CIA.S101902. eCollection 2016.'}, {'pmid': '31055167', 'type': 'RESULT', 'citation': 'Forestier E, Roubaud-Baudron C, Fraisse T, Patry C, Gavazzi G, Hoen B, Carauz-Paz P, Moheb-Khosravi B, Delahaye F, Sost G, Paccalin M, Nazeyrollas P, Strady C, Alla F, Selton-Suty C; AEPEI and the GInGer Elderl-IE study group; AEPEI and the GInGer Elderl-IE study group. Comprehensive geriatric assessment in older patients suffering from infective endocarditis. A prospective multicentric cohort study. Clin Microbiol Infect. 2019 Oct;25(10):1246-1252. doi: 10.1016/j.cmi.2019.04.021. Epub 2019 May 2.'}, {'pmid': '31758501', 'type': 'RESULT', 'citation': 'Forestier E, Selton-Suty C, Roubaud-Baudron C. Managing infective endocarditis in older patients: do we need a geriatrician? Aging Clin Exp Res. 2021 Mar;33(3):719-722. doi: 10.1007/s40520-019-01400-6. Epub 2019 Nov 22.'}, {'pmid': '37147149', 'type': 'RESULT', 'citation': "N'cho-Mottoh MB, Erpelding ML, Roubaud C, Delahaye F, Fraisse T, Dijos M, Ennezat PV, Fluttaz A, Richard B, Beaufort C, Nazeyrollas P, Brasselet C, Pineau O, Tattevin P, Curlier E, Iung B, Forestier E, Selton-Suty C. The impact of transoesophageal echocardiography in elderly patients with infective endocarditis. Arch Cardiovasc Dis. 2023 May;116(5):258-264. doi: 10.1016/j.acvd.2023.04.001. Epub 2023 Apr 25."}]}, 'descriptionModule': {'briefSummary': 'ELDERL-IE is a multicenter national prospective observational study.\n\nThe main objective is to describe geriatric characteristics (comorbidities, cognitive status, autonomy, nutritional status, balance and walking) in patients aged 75 years or older with infective endocarditis (IE).\n\nThe secondary objectives are to assess the impact of geriatric features on the medico - surgical care and on morbidity and mortality at 3 months after the end of the hospitalization, and to describe the initial clinical presentation and diagnostic modalities in the IE elderly.', 'detailedDescription': 'Population monitoring:\n\nClinical, therapeutic, biological, microbiological, echocardiographic and geriatric data are collected. (M-2/3 before inclusion; D-15 before inclusion; D0; M3; vital status at 1 year)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '75 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients older than 75 years are eligible if they are considered and treated as a case of IE by physicians ensuring their medical care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* all patients older than 75 years are eligible if they are considered and treated as a case of IE by physicians ensuring their medical care.\n* the patient should be treated in one of the clinical sites participating at the study.\n* the patient should benefit during initial hospitalization of a geriatric assessment, in addition to the usual clinical and therapeutic management of such patients.\n\nExclusion criteria :\n\n* patients not fulfilling the criteria of definite or possible endocarditis according to Duke modified by Li diagnostic classification that will be applied after collection of all the data at the discharge of the patient.'}, 'identificationModule': {'nctId': 'NCT02910856', 'acronym': 'ELDERL-IE', 'briefTitle': 'Infective Endocarditis in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Infective Endocarditis in the Elderly: Description of the Geriatric Characteristics and Their Influence on Therapeutic Care and the Morbidity and Mortality at 3 Months (ELDERL-IE)', 'orgStudyIdInfo': {'id': 'PSS 2014/ELDERL-IE-SELTON/SR'}}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'Central Hospital - University Hospital', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Christine Selton-Suty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Cœur et Recherche', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Christine Selton-Suty', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}