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OpenTrials
Completed

NCT Number: NCT05530837

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital de La Croix Rousse, Lyon, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Describe the epidemiology and clinical presentations of patients with Enterococcus faecalis endocarditis

    Time frame: Month 1

    This outcome corresponds to the evaluation of factors associated with mortality in patients with Enterococcus faecalis endocarditis.

Secondary outcomes

  1. Impact of increasing the minimum inhibitory concentrations of amoxicillin on the outcome of Enterococcus faecalis infective endocarditis

    Time frame: Month 1

    This outcome corresponds to the description of the epidemiology of Enterococcus faecalis endocarditis in France.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: ENDO_ENTERO

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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