Clinical trial NCT03272724: French National Observatory on Infective Endocarditis
Official title: French National Observatory on Infective Endocarditis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infective Endocarditis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Bichat Hospital
name: Centre Hospitalier Universitaire de la Guadeloupe
name: Centre Hospitalier Universitaire de Besancon
name: Hospices Civils de Lyon
name: University Hospital, Montpellier
name: Rennes University Hospital
name: Hôpital Saint André, Reims
name: Henri Mondor University Hospital
name: Polyclinique Courlancy, Reims
name: Centre Hospitalier Universitaire de Saint Etienne
name: Bicetre Hospital
name: Centre Hospitalier Universitaire, Amiens
name: Centre Hospitalier Universitaire Dijon
name: Centre Hospitalier Annecy Genevois
name: Centre Hospitalier de Roanne
name: Centre hospitalier Pierre Oudot Bourgoin-Jallieu
name: L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
name: Hôpital d'Instruction des Armées Desgenettes
name: Hôpital intercommunal Sud Léman Valserine, Saint Julien en Genevois
name: University Hospital, Grenoble
name: Centre Cardiologique du Nord
name: Centre Hospitalier Intercommunal Robert Ballanger
name: Raincy Montfermeil Hospital Group
name: Pitié-Salpêtrière Hospital
name: Hôpital Cochin
name: Hospital Avicenne
name: Beaujon Hospital
name: European Georges Pompidou Hospital
name: Hopital Foch
name: Hotel Dieu Hospital
name: Hôpital Jean Verdier
name: Hopital Lariboisière
name: Hôpital Necker-Enfants Malades
name: Fondation Hôpital Saint-Joseph
name: Saint-Louis Hospital, Paris, France
name: Tenon Hospital, Paris
name: Saint Antoine University Hospital
name: Centre hospitalier de Saint Dié des Vosges
name: Centre Hospitalier Régional Metz-Thionville
name: Hôpital d'Instruction des Armées Legouest
name: Hôpital sainte Blandine Metz
name: Hôpital-clinique Claude Bernard, Metz
name: Polyclinique Louis Pasteur Essey-les-Nancy
name: Hopital Nord Franche-Comte
name: Lons le Saunier hospital
name: Pontarlier hospital
name: Epernay hospital
name: Chalons en Champagne hospital
name: Clinique Saint Vincent Epernay
name: Hôpital Maison Blanche Reims
name: Hopital Universitaire Robert-Debre
name: Beziers Hospital
name: Louis Pasteur hospital, Bagnols sur Cèze
name: Centre hospitalier de Perpignan
name: Narbonne Hospital
name: Clinique du Millenaire
name: Centre Hospitalier Universitaire de Nīmes
name: Saint Malo hospital
name: HIA Begin, Saint Mandé
name: Centre Hospitalier d'Alès-Cévennes
name: University Hospital, Bordeaux
name: Centre hospitalier de Chambéry
name: Poitiers University Hospital
name: Centre Hospitalier Intercommunal Villeneuve Saint Georges
name: Centre Hospitalier Argenteuil
name: Hospital St. Joseph, Marseille, France
name: Centre hospitalier de Vannes
name: University Hospital, Strasbourg, France
name: Centre Hospitalier Régional d'Orléans
First posted: 2017-09-06
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult hospitalized patients, suspected of infective endocarditis

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: history of heart disease
timeFrame: inclusion
measure: risk factors, medical history
timeFrame: inclusion
measure: origin of infection
timeFrame: period of 3 months before infective endocarditis
measure: weight
timeFrame: inclusion
measure: height
timeFrame: inclusion
measure: clinical symptoms
timeFrame: inclusion
measure: biological outcomes
timeFrame: inclusion
measure: microbiological outcomes
timeFrame: inclusion
measure: diagnostic imaging
timeFrame: inclusion
measure: antibiotic therapy
timeFrame: from inclusion to recovery
measure: surgical procedures
timeFrame: from inclusion to recovery
Secondary outcomes:
measure: biologic collection (optional)
timeFrame: inclusion
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU
Study officials:
affiliation: CHRU Nancy
name: Christine SELTON-SUTY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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; Association pour l'Etude et la Prevention de l'Endocardite Infectieuse-ObservatoireEI Study Group. Compared Performance of the 2023 Duke-International Society for Cardiovascular Infectious Diseases, 2000 Modified Duke, and 2015 European Society of Cardiology Criteria for the Diagnosis of Infective Endocarditis in a French Multicenter Prospective Cohort. Clin Infect Dis. 2024 Apr 10;78(4):937-948. doi: 10.1093/cid/ciae035.