Clinical trial NCT05530837: Characterization of Enterococcus Faecalis Endocarditis and Impact of Amoxicillin MIC Elevation on Patient Outcome
Official title: Characterization of Enterococcus Faecalis Endocarditis and Impact of Amoxicillin MIC Elevation on Patient Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infectious Endocarditis
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient over 18 years of age with a diagnosis of Enterococcus faecalis infective endocarditis based on Duke criteria

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.


Eligibility criteria: 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

Primary outcomes:
measure: Describe the epidemiology and clinical presentations of patients with Enterococcus faecalis endocarditis
timeFrame: Month 1
Secondary outcomes:
measure: Impact of increasing the minimum inhibitory concentrations of amoxicillin on the outcome of Enterococcus faecalis infective endocarditis
timeFrame: Month 1
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de La Croix Rousse
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Benoit PILMIS, MD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.