Treatment of Enterococcus Faecalis Bacterem (E-faecalis)

December 9, 2025 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Yvon RUCH, MD
        • Sub-Investigator:
          • Thibaut FABACHER, Statistician
        • Sub-Investigator:
          • Frédéric SCHRAMM, MD
        • Principal Investigator:
          • Laura HEINRICH, MD
        • Sub-Investigator:
          • Thibaut GOETSCH, Statistician

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult subject 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intrahospital all-cause mortality
Time Frame: Up to 6 months
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

December 23, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9378 (Ferdows Shafa)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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