Clinical trial NCT02910856: Infective Endocarditis in the Elderly
Official 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infective Endocarditis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Fondation Cœur et Recherche
First posted: 2016-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: Population monitoring:

Clinical, 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline geriatric characteristics at 3 months
timeFrame: 3 months after inclusion
Secondary outcomes:
measure: Three months mortality
timeFrame: 3 months after inclusion
measure: One year mortality
timeFrame: 1 year after inclusion
measure: Change from baseline geriatric characteristics at 3 months
timeFrame: 3 months after inclusion
measure: Change from baseline geriatric characteristics at 3 months
timeFrame: 3 months after inclusion
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central Hospital - University Hospital
Study officials:
affiliation: Central Hospital, Nancy, France
name: Christine Selton-Suty, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.