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

Completed

• Conditions: Infectious Endocarditis

• Registration Number: NCT05530837
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-08
• Primary Completion: 2022-07-07
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Study Completion: 2023-03-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 281

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Describe the epidemiology and clinical presentations of patients with Enterococcus faecalis endocarditis	Month 1	This outcome corresponds to the evaluation of factors associated with mortality in patients with Enterococcus faecalis endocarditis.

Secondary Outcome Measures

Name	Time	Method
Impact of increasing the minimum inhibitory concentrations of amoxicillin on the outcome of Enterococcus faecalis infective endocarditis	Month 1	This outcome corresponds to the description of the epidemiology of Enterococcus faecalis endocarditis in France.

Trial Locations

Locations (2)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France

Hôpital de La Croix Rousse; 🇫🇷 Lyon, France