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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02910856
Other study ID # PSS 2014/ELDERL-IE-SELTON/SR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2015
Est. completion date July 2017

Study information

Verified date January 2024
Source Central Hospital, Nancy, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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)


Recruitment information / eligibility

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.

Study Design


Locations

Country Name City State
France Central Hospital - University Hospital Nancy

Sponsors (2)

Lead Sponsor Collaborator
Central Hospital, Nancy, France Fondation Cœur et Recherche

Country where clinical trial is conducted

France, 

References & Publications (4)

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

Outcome

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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