Infective Endocarditis Clinical Trial
— ELDERL-IEOfficial title:
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)
Verified date | January 2024 |
Source | Central Hospital, Nancy, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
ELDERL-IE is a multicenter national prospective observational study. The 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). The 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.
Status | Completed |
Enrollment | 120 |
Est. completion date | July 2017 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility | Inclusion Criteria : - 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. - the patient should be treated in one of the clinical sites participating at the study. - the patient should benefit during initial hospitalization of a geriatric assessment, in addition to the usual clinical and therapeutic management of such patients. Exclusion criteria : - 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. |
Country | Name | City | State |
---|---|---|---|
France | Central Hospital - University Hospital | Nancy |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France | Fondation Cœur et Recherche |
France,
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. — View 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- — View 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. — View 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 echocar — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline geriatric characteristics at 3 months | OMS score | 3 months after inclusion | |
Secondary | Three months mortality | Mortality rate at 3 months | 3 months after inclusion | |
Secondary | One year mortality | Mortality rate at 1 year | 1 year after inclusion | |
Secondary | Change from baseline geriatric characteristics at 3 months | Karnofsky'score | 3 months after inclusion | |
Secondary | Change from baseline geriatric characteristics at 3 months | Score MNA | 3 months after inclusion |
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