French National Observatory on Infective Endocarditis (ObservatoireEI)

The objective of this observatory is to provide a national database of infective endocarditis, informed by all volunteer centers, using a standardized case report forms.

Such an observatory will describe the clinical profile, microbiological, therapeutic and evolving of infective endocarditis (IE); analyze the risk factors for the disease and its prognosis factors of evolution; describe management practices; evaluate and compare in the real drug treatment strategies (including antibiotics) and surgical.

Study Overview

• Status: Recruiting
• Conditions: Infective Endocarditis

Detailed Description

All the clinical, biological, microbiological and laboratory describing the history of patients and their evolution during hospitalization for infective endocarditis will be obtained from physicians supporting patients and recorded in an electronic case report form. Will include collected clinical characteristics (site, pre-existing heart disease underlying symptoms, complications), biological characteristics (dosage on admission and diagnosis), microbiological characteristics (identifying the genus and species of the microorganism responsible, sensitivity to antibiotics susceptibility testing and evaluated by determination of minimal inhibiting concentration (MIC), exhaustive search of the rare forms of endocarditis uncultivated microorganisms), an analysis of the gateways based on the causative organism; echocardiographic characteristics (number and size of vegetations, valvular damage, scalable: surgery, lethality) and therapeutic characteristics (antibiotic treatment, surgical).

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Nadine JUGE, PhD; Email: n.juge@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54511
    • Recruiting
    • CHRU
    • Contact: Christine SELTON-SUTY, MD; Email: c.suty-selton@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult hospitalized patients, suspected of infective endocarditis

Description

Inclusion Criteria:

• Major Patient
• Supported in one of the participating centers
• The application of diagnostic classification criteria of Duke modified by Li is carried out after collection of all the data at the end of the patient's hospitalization. Only patients meeting criteria for definite or possible endocarditis will be included in the analyses.
• Registered with the French social security system

Exclusion Criteria:

• Refusal of the patient to participate.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
history of heart disease	status of heart valves, pre-existing heart conditions	inclusion
risk factors, medical history	associated diseases	inclusion
origin of infection	high risk procedures	period of 3 months before infective endocarditis
weight	kg	inclusion
height	cm	inclusion
clinical symptoms	cardiac, peripheral and neurological symptoms	inclusion
biological outcomes	blood count	inclusion
microbiological outcomes	identification of infecting organisms	inclusion
diagnostic imaging	description of tyhe imaging tests performed	inclusion
antibiotic therapy	antibiotic treatment: type and duration	from inclusion to recovery
surgical procedures	description of surgical procedures	from inclusion to recovery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biologic collection (optional)	plasma and serum collection	inclusion

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Collaborators: Hopital Universitaire Robert-Debre; Hospices Civils de Lyon; University Hospital, Strasbourg, France; Centre Hospitalier Universitaire de Saint Etienne; Centre Hospitalier Universitaire Dijon; Centre Hospitalier Universitaire, Amiens; University Hospital, Montpellier; Beaujon Hospital; Hopital Foch; University Hospital, Bordeaux; Poitiers University Hospital; Saint-Louis Hospital, Paris, France; Saint Antoine University Hospital; Centre Hospitalier Universitaire de Nīmes; Centre Hospitalier Universitaire de Besancon; Hôpital Cochin; University Hospital, Grenoble; Rennes University Hospital; Centre Hospitalier Annecy Genevois; Hospital St. Joseph, Marseille, France; Hopital Lariboisière; Centre Hospitalier Régional d'Orléans; Bicetre Hospital; Henri Mondor University Hospital; Pitié-Salpêtrière Hospital; European Georges Pompidou Hospital; Tenon Hospital, Paris; Hôpital Necker-Enfants Malades; Bichat Hospital; Centre Hospitalier Régional Metz-Thionville; Hotel Dieu Hospital; Centre Hospitalier Intercommunal Robert Ballanger; Hospital Avicenne; Centre Cardiologique du Nord; Raincy Montfermeil Hospital Group; Centre Hospitalier Universitaire de Pointe-a-Pitre; Hopital Nord Franche-Comte; Centre hospitalier de Perpignan; Beziers Hospital; Narbonne Hospital; Hôpital Jean Verdier; L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône; Centre hospitalier de Chambéry; Clinique du Millenaire; Hôpital Saint André, Reims; Polyclinique Courlancy, Reims; Centre Hospitalier de Roanne; Centre hospitalier Pierre Oudot Bourgoin-Jallieu; Hôpital d'Instruction des Armées Desgenettes; Hôpital intercommunal Sud Léman Valserine, Saint Julien en Genevois; Centre hospitalier de Saint Dié des Vosges; Hôpital d'Instruction des Armées Legouest; Hôpital sainte Blandine Metz; Hôpital-clinique Claude Bernard, Metz; Polyclinique Louis Pasteur Essey-les-Nancy; Lons le Saunier hospital; Pontarlier hospital; Epernay hospital; Chalons en Champagne hospital; Clinique Saint Vincent Epernay; Hôpital Maison Blanche Reims; Louis Pasteur hospital, Bagnols sur Cèze; Saint Malo hospital; HIA Begin, Saint Mandé; Centre Hospitalier d'Alès-Cévennes; Centre Hospitalier Intercommunal Villeneuve Saint Georges; Centre Hospitalier Argenteuil; Fondation Hôpital Saint-Joseph; Centre hospitalier de Vannes
• Investigators: Principal Investigator: Christine SELTON-SUTY, MD, CHRU Nancy

Publications and helpful links

General Publications

• Selton-Suty C, Goehringer F, Venner C, Thivilier C, Huttin O, Hoen B; membres de l'Endocarditis Team du CHU de Nancy. [Complications and prognosis of infective endocarditis]. Presse Med. 2019 May;48(5):532-538. doi: 10.1016/j.lpm.2019.04.002. Epub 2019 May 2. French.
• Hoen B, Elfarra M, Huttin O, Goehringer F, Venner C, Selton-Suty C; l'Endocarditis Team du CHU de Nancy. [Treatment of infectious endocarditis]. Presse Med. 2019 May;48(5):539-548. doi: 10.1016/j.lpm.2019.04.015. Epub 2019 May 18. French.
• N'Guyen Y, Duval X, Revest M, Saada M, Erpelding ML, Selton-Suty C, Bouchiat C, Delahaye F, Chirouze C, Alla F, Strady C, Hoen B; AEPEI study group. Time interval between infective endocarditis first symptoms and diagnosis: relationship to infective endocarditis characteristics, microorganisms and prognosis. Ann Med. 2017 Mar;49(2):117-125. doi: 10.1080/07853890.2016.1235282. Epub 2016 Nov 3.
• Lefevre B, Hoen B, Goehringer F, Sime WN, Aissa N, Alauzet C, Jeanmaire E, Henard S, Filippetti L, Selton-Suty C, Agrinier N; for AEPEI study group (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse). Antistaphylococcal penicillins vs. cefazolin in the treatment of methicillin-susceptible Staphylococcus aureus infective endocarditis: a quasi-experimental monocentre study. Eur J Clin Microbiol Infect Dis. 2021 Dec;40(12):2605-2616. doi: 10.1007/s10096-021-04313-3. Epub 2021 Aug 12.
• Collonnaz M, Erpelding ML, Alla F, Goehringer F, Delahaye F, Iung B, Le Moing V, Hoen B, Selton-Suty C, Agrinier N; AEPEI Study Group. Impact of referral bias on prognostic studies outcomes: insights from a population-based cohort study on infective endocarditis. Ann Epidemiol. 2021 Feb;54:29-37. doi: 10.1016/j.annepidem.2020.09.008. Epub 2020 Sep 18.
• Collonnaz M, Erpelding ML, Alla F, Goehringer F, Delahaye F, Iung B, Le Moing V, Hoen B, Selton-Suty C, Agrinier N; AEPEI study group. Data on prognostic factors associated with 3-month and 1-year mortality from infective endocarditis. Data Brief. 2020 Nov 1;33:106478. doi: 10.1016/j.dib.2020.106478. eCollection 2020 Dec.
• De Ciancio G, Erpelding ML, Filippetti L, Goehringer F, Blangy H, Huttin O, Agrinier N, Juilliere Y, Sadoul N, Selton-Suty C. Adherence to diagnostic and therapeutic practice guidelines for suspected cardiac implantable electronic device infections. Arch Cardiovasc Dis. 2021 Oct;114(10):634-646. doi: 10.1016/j.acvd.2021.06.010. Epub 2021 Nov 3.
• Selton-Suty C, Delahaye F, Tattevin P, Federspiel C, Le Moing V, Chirouze C, Nazeyrollas P, Vernet-Garnier V, Bernard Y, Chocron S, Obadia JF, Alla F, Hoen B, Duval X; AEPEI (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse). Symptomatic and Asymptomatic Neurological Complications of Infective Endocarditis: Impact on Surgical Management and Prognosis. PLoS One. 2016 Jul 11;11(7):e0158522. doi: 10.1371/journal.pone.0158522. eCollection 2016.
• Radjabaly Mandjee A, Filippetti L, Goehringer F, Duval X, Botelho-Nevers E, Tribouilloy C, Huguet R, Chirouze C, Erpelding ML, Hoen B, Selton-Suty C, Agrinier N, Lefevre B; investigators of the French AEPEI Observatory on Infective Endocarditis (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse). Characteristics of patients with infective endocarditis and no underlying cardiac conditions. Infect Dis (Lond). 2022 Sep;54(9):656-665. doi: 10.1080/23744235.2022.2078404. Epub 2022 May 23.
• Beraud G, Tubiana S, Erpelding ML, Le Moing V, Chirouze C, Gorenne I, Manchon P, Tattevin P, Vernet V, Varon E, Hoen B, Duval X; AEPEI study group; COMBAT study group. Combined Bacterial Meningitis and Infective Endocarditis: When Should We Search for the Other When Either One is Diagnosed? Infect Dis Ther. 2022 Aug;11(4):1521-1540. doi: 10.1007/s40121-022-00651-7. Epub 2022 May 26.
• Lefevre B, Legoff A, Boutrou M, Goehringer F, Ngueyon-Sime W, Chirouze C, Revest M, Vernet Garnier V, Duval X, Delahaye F, Le Moing V, Selton-Suty C, Filippetti L, Hoen B, Agrinier N. Staphylococcus aureus endocarditis: Identifying prognostic factors using a method derived from morbidity and mortality conferences. Front Med (Lausanne). 2022 Dec 6;9:1053278. doi: 10.3389/fmed.2022.1053278. eCollection 2022.
• Fowler VG, Durack DT, Selton-Suty C, Athan E, Bayer AS, Chamis AL, Dahl A, DiBernardo L, Durante-Mangoni E, Duval X, Fortes CQ, Fosbol E, Hannan MM, Hasse B, Hoen B, Karchmer AW, Mestres CA, Petti CA, Pizzi MN, Preston SD, Roque A, Vandenesch F, van der Meer JTM, van der Vaart TW, Miro JM. The 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis: Updating the Modified Duke Criteria. Clin Infect Dis. 2023 Aug 22;77(4):518-526. doi: 10.1093/cid/ciad271. Erratum In: Clin Infect Dis. 2023 Oct 13;77(8):1222.
• Bucy L, Erpelding ML, Boursier C, Lefevre B, Alauzet C, Liu Y, Chevalier E, Huttin O, Agrinier N, Selton-Suty C, Goehringer F; AEPEI study group (Association pour l'Etude et la Prevention de l'Endocardite Infectieuse). Real world experience of therapeutic monitoring of medically treated prosthetic valve infective endocarditis by 18F-FDG-PET/CT. J Nucl Cardiol. 2023 Oct;30(5):2096-2103. doi: 10.1007/s12350-023-03339-8. Epub 2023 Jul 31.
• El Hatimi S, Erpelding ML, Selton-Suty C, Botros JB, Goehringer F, Berthelot E, Elfarra M, Deconinck L, Para M, Provenchere S, Hoen B, Agrinier N, Duval X, Iung B. Predictive performance of surgical mortality risk scores in infective endocarditis. Eur J Cardiothorac Surg. 2024 Jan 2;65(1):ezad433. doi: 10.1093/ejcts/ezad433.
• Goehringer F, Lalloue B, Selton-Suty C, Alla F, Botelho-Nevers E, Chirouze C, Curlier E, El Hatimi S, Gagneux-Brunon A, le Moing V, Lim P, Piroth L, Strady C, Tribouilloy C, Virion JM, Agrinier N, Duval X, Hoen B; AEPEI - ObservatoireEI study group. Compared Performance of the 2023 Duke-International Society for Cardiovascular Infectious Diseases, the 2000 Modified Duke, and the 2015 ESC Criteria for the Diagnosis of Infective Endocarditis in a French Multicenter Prospective Cohort. Clin Infect Dis. 2024 Feb 8:ciae035. doi: 10.1093/cid/ciae035. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1991
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 31, 2017
• First Posted (Actual): September 6, 2017

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Cardiovascular Infections; Endocarditis, Bacterial; Endocarditis
• Other Study ID Numbers: Observatoire EI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No