Infective Endocarditis (IE)BAC-ENDONCT07313865
From Commensalism to Pathogenicity: Exploring the Pathophysiology of Bacteremia to Better Understand Enterococcus Faecalis Infective Endocarditis
A study testing Microbiological sampling (swab collection) in people with Infective Endocarditis (IE), run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Enterococci are pathobionts of the human intestinal microbiota: they colonize the gastrointestinal tract as well as the skin, urine, wounds, bile, the oral cavity and endodontic canal, and medical devices (urinary catheters, venous catheters, etc.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis (IE)
- What is being tested?
- Microbiological sampling (swab collection)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and older;
- Capable of giving informed consent;
- Affiliated with a social security system;
- Hospitalized with at least one positive blood culture for Enterococcus faecalis, without an obvious clinical entry point after physical examination and initial routine investigations (BIEF group);
- Hospitalized for another bacteremia, without an obvious clinical entry point after initial routine investigations (Control group);
- Receiving antibiotic therapy that was started less than 48 hours ago
Who cannot join
- Refusal to participate in the study;
- Pregnant or breastfeeding women;
- Individuals under guardianship, curatorship, deprived of liberty, or under judicial protection;
- Antibiotic therapy for the current infectious episode started more than 48 hours prior to inclusion.
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
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63000
Magali VIDAL, 04 73 75 49 31, mvidal@chu-clermontferrand.fr
mvidal@chu-clermontferrand.fr
About this study
Official title: From Commensalism to Pathogenicity: Exploring the Pathophysiology of Bacteremia to Better Understand Enterococcus Faecalis Infective Endocarditisléter
Enterococci are pathobionts of the human intestinal microbiota: they colonize the gastrointestinal tract as well as the skin, urine, wounds, bile, the oral cavity and endodontic canal, and medical devices (urinary catheters, venous catheters, etc.). They are responsible for urinary, dental, bloodstream, endocardial, biliary, and gastrointestinal infections.
Enterococcus faecalis is the enterococcus most frequently isolated from clinical specimens. It is the third leading cause of infective endocarditis (infection of the cardiac valves) and the leading cause of endocarditis following TAVI (transcatheter aortic valve implantation via the femoral route). E. faecalis infective endocarditis (EFIE) is severe and difficult to treat, with a particularly high relapse rate despite appropriate antibiotic therapy.
Read more
Cardiac valve contamination is always secondary to E. faecalis bacteremia, particularly in cases of isolated E. faecalis bacteremia (EFIB), defined by the absence of an identifiable portal of entry. Once in the bloodstream, the bacterium adheres to the valvular endothelium (healthy or damaged) through specific virulence factors, including endocarditis- and biofilm-associated pili (ebp), the collagen adhesin Ace, and aggregation substance (Agg).
The classical portals of entry for EFIE are infections of the urinary tract and the gastrointestinal tract. However, despite extensive investigations, the source of infection remains unidentified in more than 50% of cases. An imbalance of the intestinal microbiota, leading to overgrowth and subsequent translocation of E. faecalis from the digestive tract into the bloodstream, could explain the absence of an identifiable portal of entry during routine clinical and paraclinical evaluations. This plausible hypothesis remains largely unexplored to date. A better understanding of the underlying pathophysiology-particularly gut dysbiosis and the pathogen's capacity for intestinal translocation-could improve the prevention of EFIE occurrence and relapse.
- Conditions
- Infective Endocarditis (IE)
- Being tested
- Microbiological sampling (swab collection)
- Keywords
- Enterococcus faecalis, Bacteremia, Dysbiosis, Pathophysiology, Virulence factors
- Medical subject headings
- Endocarditis, Bacteremia, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological sampling (swab collection)Biological
Participants in the case group will undergo microbiological sampling consisting of four swabs: two rectal swabs, one oral swab, and one skin swab from the inguinal fold.
Participants in the control group will undergo a single rectal swab. The samples will be collected for microbiological analysis.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Other | Collection of four swabs (two rectal swabs, one oral swab, and one skin swab from the inguinal fold). Receives: Biological: Microbiological sampling (swab collection) |
| Controls | Other | Collection of a single rectal swab. Receives: Biological: Microbiological sampling (swab collection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative and quantitative bacterial composition of the intestinal microbiota (molecular microbiology/PCR).
Measured: From enrollment to the collection of the four swabs: 24 to 48 hours.
Secondary outcomes (4)
Mapping of E. faecalis colonization (urinary, digestive, and/or cutaneous) in patients diagnosed with E. faecalis bacteremia (EFIB);
Measured: From enrollment to the collection of the four swabs: 24 to 48 hours.
Genomic characterization through core genome analysis of E. faecalis strains isolated from colonization sites and from blood cultures in the same patient diagnosed with EFIB;
Measured: From enrollment to the collection of the four swabs: 24 to 48 hours.
Whole-genome characterization of E. faecalis strains isolated from colonization sites and those recovered from blood cultures in patients with EFIB;
Measured: From enrollment to the collection of the four swabs: 24 to 48 hours.
Description of potential portals of entry for enterococci at the end of hospitalization for EFIB.
Measured: From enrollment to the collection of the four swabs: 24 to 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start17 Apr 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective Endocarditis (IE)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magali VIDAL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313865
- Sponsor's protocol ID
- RBHP 2025 VIDAL
- Acronym
- BAC-ENDO
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 13 Oct 2026
- 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 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Commensalism to Pathogenicity: Exploring the Pathophysiology of Bacteremia to Better Understand Enterococcus Faecalis Infective Endocarditisléter
- ClinicalTrials.gov ID
- NCT07313865
- Acronym / sponsor ID
- BAC-ENDO / RBHP 2025 VIDAL
- Conditions
- Infective Endocarditis (IE)
- Keywords
- Enterococcus faecalis, Bacteremia, Dysbiosis, Pathophysiology, Virulence factors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jan 2026 (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.
Enterococci are pathobionts of the human intestinal microbiota: they colonize the gastrointestinal tract as well as the skin, urine, wounds, bile, the oral cavity and endodontic canal, and medical devices (urinary catheters, venous catheters, etc.). They are responsible for urinary, dental, bloodstream, endocardial, biliary, and gastrointestinal infections.
Enterococcus faecalis is the enterococcus most frequently isolated from clinical specimens. It is the third leading cause of infective endocarditis (infection of the cardiac valves) and the leading cause of endocarditis following TAVI (transcatheter aortic valve implantation via the femoral route). E. faecalis infective endocarditis (EFIE) is severe and difficult to treat, with a particularly high relapse rate despite appropriate antibiotic therapy.
Cardiac valve contamination is always secondary to E. faecalis bacteremia, particularly in cases of isolated E. faecalis bacteremia (EFIB), defined by the absence of an identifiable portal of entry. Once in the bloodstream, the bacterium adheres to the valvular endothelium (healthy or damaged) through specific virulence factors, including endocarditis- and biofilm-associated pili (ebp), the collagen adhesin Ace, and aggregation substance (Agg).
The classical portals of entry for EFIE are infections of the urinary tract and the gastrointestinal tract. However, despite extensive investigations, the source of infection remains unidentified in more than 50% of cases. An imbalance of the intestinal microbiota, leading to overgrowth and subsequent translocation of E. faecalis from the digestive tract into the bloodstream, could explain the absence of an identifiable portal of entry during routine clinical and paraclinical evaluations. This plausible hypothesis remains largely unexplored to date. A better understanding of the underlying pathophysiology-particularly gut dysbiosis and the pathogen's capacity for intestinal translocation-could improve the prevention of EFIE occurrence and relapse.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Other | Biological: Microbiological sampling (swab collection)Collection of four swabs (two rectal swabs, one oral swab, and one skin swab from the inguinal fold). |
| Controls | Other | Biological: Microbiological sampling (swab collection)Collection of a single rectal swab. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged 18 years and older;
- Capable of giving informed consent;
- Affiliated with a social security system;
- Hospitalized with at least one positive blood culture for Enterococcus faecalis, without an obvious clinical entry point after physical examination and initial routine investigations (BIEF group);
- Hospitalized for another bacteremia, without an obvious clinical entry point after initial routine investigations (Control group);
Key exclusion criteria (4 listed)
- Refusal to participate in the study;
- Pregnant or breastfeeding women;
- Individuals under guardianship, curatorship, deprived of liberty, or under judicial protection;
- Antibiotic therapy for the current infectious episode started more than 48 hours prior to inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiological sampling (swab collection)Participants in the case group will undergo microbiological sampling consisting of four swabs: two rectal swabs, one oral swab, and one skin swab from the inguinal fold. Participants in the control group will undergo a single rectal swab. The samples will be collected for microbiological analysis. | Biological | Cases, Controls |
Primary outcome
Qualitative and quantitative bacterial composition of the intestinal microbiota (molecular microbiology/PCR).
Time frame: From enrollment to the collection of the four swabs: 24 to 48 hours.
4 secondary outcomes
Mapping of E. faecalis colonization (urinary, digestive, and/or cutaneous) in patients diagnosed with E. faecalis bacteremia (EFIB);
Time frame: From enrollment to the collection of the four swabs: 24 to 48 hours.
Genomic characterization through core genome analysis of E. faecalis strains isolated from colonization sites and from blood cultures in the same patient diagnosed with EFIB;
Time frame: From enrollment to the collection of the four swabs: 24 to 48 hours.
Whole-genome characterization of E. faecalis strains isolated from colonization sites and those recovered from blood cultures in patients with EFIB;
Time frame: From enrollment to the collection of the four swabs: 24 to 48 hours.
Description of potential portals of entry for enterococci at the end of hospitalization for EFIB.
Time frame: From enrollment to the collection of the four swabs: 24 to 48 hours.
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 13 Oct 2026.
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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.
Magali VIDAL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiological sampling (swab collection) in people with Infective Endocarditis (IE), run by University Hospital, Clermont-Ferrand 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 6 inclusion and 4 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 13 Oct 2026. 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 Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative and quantitative bacterial composition of the intestinal microbiota (molecular microbiology/PCR). (time frame: From enrollment to the collection of the four swabs: 24 to 48 hours.). 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 13 Oct 2026.