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

NCT05530837 | Completed

• 1 other identifier: ENDO_ENTERO
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 2

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.

Conditions

Infectious Endocarditis

Outcome Measures

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.

  Month 1

Secondary Outcomes (1)

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

  Month 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (2)

Hôpital de La Croix Rousse

Lyon, 69004, France

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related 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.

  PMID: 35011748 BACKGROUND

• 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.

  PMID: 35265458 BACKGROUND

• 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.

  PMID: 34805443 BACKGROUND

• 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.

  PMID: 30851401 BACKGROUND

MeSH Terms

Conditions

Endocarditis, Subacute Bacterial

Condition Hierarchy (Ancestors)

Endocarditis, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Cardiovascular Infections; Cardiovascular Diseases; Endocarditis; Heart Diseases

Study Officials

• Benoit PILMIS, MD

  Fondation Hôpital Saint-Joseph

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: June 8, 2022
• Primary Completion: July 7, 2022
• Study Completion: March 15, 2023
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

FR (2)