ClinicalTrials.gg
RecruitingNCT07313865BAC-ENDOUpdated Oct 13, 2026

From Commensalism to Pathogenicity: Exploring the Pathophysiology of Bacteremia to Better Understand Enterococcus Faecalis Infective Endocarditis

An interventional study of Microbiological sampling (swab collection) in Infective Endocarditis (IE), sponsored by University Hospital, Clermont-Ferrand. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Oct 13, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 47 studies in Endocarditis with a site in France — 13 open to participants now, 15 under way, 1 of them phase 3. Endocarditis · France.

Planned enrollment
16th of 28
90 · median 144
Started
2026
with 3 others
No phase
20 of 47
8 open now
Primary completion
2028-12
later than 12 of 14 live
Registered
45th of 47
by date
Lead sponsor
2 of 47
University Hospital, Clermont-Ferrand

Among the 47 studies in Endocarditis with a site in France, this one is the 16th largest by planned enrollment of the 28 interventional ones, is one of 4 that started in 2026, is one of 20 with no phase, reaches primary completion later than 12 of the 14 other live ones, and was the 45th registered.

By phase

47 studies; the count open now beside each. This study's row is marked.

No phasethis study20 · 8 open
Observational19 · 4 open
Phase 33 · 1 open
Phase 22 · 0 open
Phase 42 · 0 open
Phase 1/21 · 0 open

By the year they started

First in 1991; this study’s year is marked. 4 started in 2026.

Size and results

Median enrollment 144 across the 28 interventional studies, 269 across the 19 observational. Of the 25 that completed or were terminated, 1 (4%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 47 studies in Endocarditis with a site in France, or all of them as a file.
02

Study 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.). 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.

03

Conditions studied

  • Infective Endocarditis (IE)

Keywords

  • Enterococcus faecalis
  • Bacteremia
  • Dysbiosis
  • Pathophysiology
  • Virulence factors
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 years and older;
  • Capable of giving ;
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Other
    Cases

    Collection of four swabs (two rectal swabs, one oral swab, and one skin swab from the inguinal fold).

    Biological: Microbiological sampling (swab collection)

  • Other
    Controls

    Collection of a single rectal swab.

    Biological: Microbiological sampling (swab collection)

Interventions

  • BiologicalMicrobiological 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.

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Dec 2028, 32 months after the start.

Of 34 interventional studies with no phase under Endocarditis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 59. This study's planned 32 months is close to that.

Start moved once since we started tracking on Sep 25, 2026: Jan 2026 → Apr 2026, on Oct 13, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Dec 17, 2025
First posted
Jan 2, 2026
StartActual
Apr 17, 2026was Jan 2026
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 13, 2026
Sites
CHU de Clermont-Ferrand is now Recruiting
Oct 13, 2026
Start date
Jan 2, 2026→Apr 17, 2026 (actual)
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Not yet recruiting→Recruiting
    CHU de Clermont-Ferrand is now Recruiting
    Start date Jan 2, 2026→Apr 17, 2026 (now actual)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07313865
Responsible party
Sponsor
First posted
Jan 2, 2026
Start date
Apr 17, 2026
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Lise Laclautre
Contact
promo_interne_drci@chu-clermontferrand.fr
334.73.754.963
Magali VIDAL
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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