Enterococcus Faecalis BacteremiaE-faecalisNCT07299539
Treatment of Enterococcus Faecalis Bacterem
An observational study of Enterococcus Faecalis Bacteremia, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enterococcus Faecalis Bacteremia
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2024to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Strasbourg, 67091
Yvon RUCH, MD, 33 3 69 55 12 19, yvon.ruch@chru-strasbourg.fr
Yvon RUCH, MD
About this study
Official title: 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.
- Conditions
- Enterococcus Faecalis Bacteremia
- Keywords
- Enterococcus faecalis bacteremia, Mortality, Monotherapy versus combination therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrahospital all-cause mortality
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start24 Feb 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enterococcus Faecalis BacteremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299539
- Sponsor's protocol ID
- 9378
- Acronym
- E-faecalis
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact on Mortality of the Choice Between a Mono- Versus Combination Antibiotic Therapy in Enterococcus Faecalis Bacteremia
- ClinicalTrials.gov ID
- NCT07299539
- Acronym / sponsor ID
- E-faecalis / 9378
- Conditions
- Enterococcus Faecalis Bacteremia
- Keywords
- Enterococcus faecalis bacteremia, Mortality, Monotherapy versus combination therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Feb 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intrahospital all-cause mortality
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
Related trials for Enterococcus Faecalis Bacteremia
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From Commensalism to Pathogenicity: Exploring the Pathophysiology of Bacteremia to Better Understand Enterococcus Faecalis Infective Endocarditis
Infective Endocarditis (IE)
RecruitingObservational study
Antimicrobial Combination Therapy for Treatment of Enterococcus Faecalis Bacteremia
Enterococcus Faecalis Infection, Blood Stream Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Enterococcus Faecalis Bacteremia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yvon RUCH, MD (33 3 69 55 12 1, yvon.ruch@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intrahospital all-cause mortality (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.