French National Observatory on Infective Endocarditis

Infective Endocarditis Clinical Trial

— ObservatoireEI  

Official title:

French National Observatory on Infective Endocarditis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03272724
• Other study ID #: Observatoire EI
• Status: Recruiting
• Start date: January 1, 1991
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Central Hospital, Nancy, France
• Contact: Nadine JUGE, PhD
• Email: n.juge[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Locations

Country	Name	City	State
France	CHRU	Vandœuvre-lès-Nancy

Sponsors (70)

Lead Sponsor

Collaborator

Central Hospital, Nancy, France

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

Country where clinical trial is conducted

France, 

References & Publications (15)

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 — View 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 — View 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 No — View 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 endoc — View 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 — View 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 C — View 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 M — View 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; AEPEI - ObservatoireEI study group. Compa — View 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. — View 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 — View 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 usin — View 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 endoc — View 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 (Associati — View 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). Symptom — View 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 Ma — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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