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CompletedNCT05530837ENDO_ENTEROUpdated Sep 13, 2023

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

An observational study in Infectious Endocarditis, sponsored by Fondation Hôpital Saint-Joseph. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Fondation Hôpital Saint-Joseph · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
281
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Infectious Endocarditis
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In context

Lead sponsor

Fondation Hôpital Saint-Joseph is the lead sponsor of 344 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
281 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Month 1

Secondary outcomes

  1. 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.

    Time frame: Month 1

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Study locations

2 sites
  • Hôpital de La Croix Rousse
    Lyon, 69004, France
  • Groupe Hospitalier Paris Saint-Joseph
    Paris, 75014, France
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References and documents

Publications

  • 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. PubMed 35011748 ↗
  • 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. PubMed 35265458 ↗
  • 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. PubMed 34805443 ↗
  • 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. PubMed 30851401 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05530837
Responsible party
Sponsor
First posted
Sep 7, 2022
Start date
Jun 8, 2022
Primary completion
Jul 7, 2022
Completion
Mar 15, 2023
Last update
Sep 13, 2023

Study contacts

Benoit PILMIS, MD
study director · Fondation Hôpital Saint-Joseph

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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