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Recruiting

NCT Number: NCT07299539

Treatment of Enterococcus Faecalis Bacterem

Enterococcus faecalis is a germ frequently responsible for bacteremia which can be severe with 15-25% risk of mortality and 26% risk of infectious endocarditis. There is no recommendation for the treatment of "simple" Enterococcus faecalis bacteremia (meaning without infectious endocarditis at diagnosis), nor studies comparing monotherapy versus combination antibiotic therapy.

Our main objective is to study the impact on mortality of bacteriostatic monotherapy and bactericidal combination antibiotic therapy in patients with Enterococcus faecalis bacteremia. We aim to also study the mortality up to three months, the failures of treatment, the modalities of treatment, the renal toxicity and the bacterial resistance.

Recruiting

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Key information

Conditions

Enterococcus Faecalis Bacteremia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Frédéric SCHRAMM, MD

SUB_INVESTIGATOR

Laura HEINRICH, MD

PRINCIPAL_INVESTIGATOR

Thibaut FABACHER, Statistician

SUB_INVESTIGATOR

Thibaut GOETSCH, Statistician

SUB_INVESTIGATOR

Yvon RUCH, MD

CONTACT

[email protected]

33 3 69 55 12 19

Yvon RUCH, MD

PRINCIPAL_INVESTIGATOR

Who can participate

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

Inclusion criteria

  • Subject of legal age (≥18 years)
  • Having a positive blood culture result for Enterococcus faecalis identified within the microbiology laboratory of the University Hospital of Strasbourg during the period from 01 January 2017 to 31 December 2023.

Exclusion criteria

  • Penicillin treatment < 7 days
  • Treatment not containing a penicillin effective against enterococci among those studied: amoxicillin or piperacillin-tazobactam
  • Combination of penicillin with another antibiotic effective against enterococci other than cephalosporins or aminoglycosides (glycopeptides, linezolids, carbapenems, levofloxacin, moxifloxacin).
  • Bacteremia with one or more other pathogens within the first 7 days of bacteremia
  • Infective endocarditis at diagnosis and within the first 7 effective days of treatment
  • Resistance of Enterococcus faecalis to amoxicillin
  • Mortality <72 hours after initiation of antibiotic therapy
  • Lack of information regarding the chosen antibiotic treatment

Treatment and study plan

Primary outcomes

  1. Intrahospital all-cause mortality

    Time frame: Up to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Yvon RUCH, MD

CONTACT

[email protected]

33 3 69 55 12 1

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Impact on Mortality of the Choice Between a Mono- Versus Combination Antibiotic Therapy in Enterococcus Faecalis Bacteremia

Acronym: E-faecalis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2025
Registry last updated
Dec 23, 2025

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.