Characterization of Enterococcus Faecalis Endocarditis and Impact of Amoxicillin MIC Elevation on Patient Outcome

Infectious Endocarditis Clinical Trial

— ENDO_ENTERO  

Official title:

Characterization of Enterococcus Faecalis Endocarditis and Impact of Amoxicillin MIC Elevation on Patient Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530837
• Other study ID #: ENDO_ENTERO
• Status: Completed
• Start date: June 8, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: September 2023
• Source: Fondation Hôpital Saint-Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Infective endocarditis is a complex infection that can be life-threatening. These infections also cause anatomical lesions that can be severe. Their management is complex and involves several disciplines: cardiology, bacteriologists, infectious diseases specialists, radiologists, nuclear medicine specialists, cardiac surgeons, neurologists, pharmacologists, etc. The incidence of Enterococcus faecalis endocarditis is increasing due to the aging of the population and the disappearance of rheumatic fever. The adequate management of these infections is complex and relies on the prolonged administration of high-dose antibiotics, classically the combination of amoxicillin and ceftriaxone. In the context of Streptococcal endocarditis, the impact of increasing the Minimum Inhibitory Concentration (MIC) of amoxicillin on patient mortality has been demonstrated but no study has yet examined the impact of increasing the MIC of amoxicillin on the outcome of patients treated for Enterococcus faecalis infective endocarditis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 281
• Est. completion date: March 15, 2023
• Est. primary completion date: July 7, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years of age with a diagnosis of Enterococcus faecalis infective endocarditis based on Duke criteria

• Patient hospitalized in one of the participating centers

• French-speaking patient

Exclusion Criteria:

• Patient with suspected infective endocarditis who does not meet Duke criteria

• Patient under guardianship or curatorship

• Patient deprived of liberty

• Patient under court protection

• Patient objecting to the use of their data for this research

Related Conditions & MeSH terms

• Endocarditis
• Infectious Endocarditis

Locations

Country	Name	City	State
France	Hôpital de La Croix Rousse	Lyon
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Hôpital Saint-Joseph

Country where clinical trial is conducted

France, 

References & Publications (4)

Herrera-Hidalgo L, Lomas-Cabezas JM, Lopez-Cortes LE, Luque-Marquez R, Lopez-Cortes LF, Martinez-Marcos FJ, de la Torre-Lima J, Plata-Ciezar A, Hidalgo-Tenorio C, Garcia-Lopez MV, Vinuesa D, Gutierrez-Valencia A, Gil-Navarro MV, De Alarcon A. Ampicillin Plus Ceftriaxone Combined Therapy for Enterococcus faecalis Infective Endocarditis in OPAT. J Clin Med. 2021 Dec 21;11(1):7. doi: 10.3390/jcm11010007. — View Citation

Marino A, Munafo A, Zagami A, Ceccarelli M, Campanella E, Cosentino F, Moscatt V, Cantarella G, Di Mauro R, Bernardini R, Nunnari G, Cacopardo B. Ampicillin plus ceftriaxone therapy against Enterococcus faecalis endocarditis: A case report, guidelines considerations, and literature review. IDCases. 2022 Mar 2;28:e01462. doi: 10.1016/j.idcr.2022.e01462. eCollection 2022. — View Citation

Pilmis B, Lourtet-Hascoet J, Barraud O, Piau C, Isnard C, Hery-Arnaud G, Amara M, Merens A, Farfour E, Thomas E, Jacquier H, Zahar JR, Bonnet E, Monnier AL; GMC Study Group. Be careful about MICs to amoxicillin for patients with Streptococci-related infective endocarditis. Int J Antimicrob Agents. 2019 Jun;53(6):850-854. doi: 10.1016/j.ijantimicag.2019.03.002. Epub 2019 Mar 7. — View Citation

Shah NH, Shutt KA, Doi Y. Ampicillin-Ceftriaxone vs Ampicillin-Gentamicin for Definitive Therapy of Enterococcus faecalis Infective Endocarditis: A Propensity Score-Matched, Retrospective Cohort Analysis. Open Forum Infect Dis. 2021 Mar 6;8(4):ofab102. doi: 10.1093/ofid/ofab102. eCollection 2021 Apr. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Describe the epidemiology and clinical presentations of patients with Enterococcus faecalis endocarditis	This outcome corresponds to the evaluation of factors associated with mortality in patients with Enterococcus faecalis endocarditis.	Month 1
Secondary	Impact of increasing the minimum inhibitory concentrations of amoxicillin on the outcome of Enterococcus faecalis infective endocarditis	This outcome corresponds to the description of the epidemiology of Enterococcus faecalis endocarditis in France.	Month 1