Treatment options for Enterococcus faecalis bloodstream infection
Impact on Mortality of the Choice Between a Mono- Versus Combination Antibiotic Therapy in Enterococcus Faecalis Bacteremia
University Hospital, Strasbourg, France · NCT07299539
This project tests whether single-drug penicillin-based treatment or combination antibiotic therapy leads to better survival for adults with Enterococcus faecalis bloodstream infections.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France (other) |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT07299539 on ClinicalTrials.gov |
What this trial studies
This is a retrospective observational analysis of adults with microbiology-confirmed Enterococcus faecalis bacteremia diagnosed at the University Hospital of Strasbourg from 2017 to 2023. The work compares outcomes in patients treated with bacteriostatic monotherapy versus bactericidal penicillin-containing combination regimens. Primary outcomes include mortality up to three months, and secondary outcomes include treatment failure, renal toxicity, and development of bacterial resistance. Patients with endocarditis at diagnosis, polymicrobial bacteremia, penicillin-resistant isolates, or very early death were excluded to focus on 'simple' E. faecalis bacteremia managed with penicillin-based therapy.
Who should consider this trial
Good fit: Adults (≥18) with a blood culture positive for Enterococcus faecalis diagnosed and treated at the University Hospital of Strasbourg who did not have endocarditis at diagnosis and received a penicillin-based regimen for at least seven days.
Not a fit: People with penicillin-resistant E. faecalis, polymicrobial bacteremia, infective endocarditis at diagnosis, or who died within 72 hours of starting antibiotics were excluded and would not benefit from the study's direct conclusions.
Why it matters
Potential benefit: If findings show one approach leads to lower mortality or fewer harms, they could guide clearer treatment choices and improve survival for people with this infection.
How similar studies have performed: Direct head-to-head comparisons for simple E. faecalis bacteremia are limited, with most existing data focusing on complicated infections or extrapolated from other contexts rather than clear evidence for single versus combination therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Strasbourg
- Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France — Strasbourg, France (RECRUITING)
Study contacts
- Study coordinator: Yvon RUCH, MD
- Email: yvon.ruch@chru-strasbourg.fr
- Phone: 33 3 69 55 12 1
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Enterococcus Faecalis Bacteremia, Enterococcus faecalis bacteremia, Mortality, Monotherapy versus combination therapy