Combination versus single-drug antibiotic treatment for Enterococcus faecalis bloodstream infection
Efficacy of Optimized Antimicrobial Combination Therapy for Treatment of Enterococcus Faecalis Bacteremia and Identification of Intestinal Microbiota Signature
This project will test whether combining antibiotics helps adults with uncomplicated Enterococcus faecalis bloodstream infections recover better than a single antibiotic.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 510 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 4 sites (Bologna, Bologna and 3 other locations) |
| Trial ID | NCT06833593 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational pharmacological study conducted across Italian hospitals comparing outcomes for adults with uncomplicated Enterococcus faecalis bloodstream infection treated with appropriate monotherapy versus combination therapy. Enrolled patients have monomicrobial EF-BSI and receive at least five days of an in vitro–active antibiotic with or without a synergistic agent; clinical outcomes and short-term mortality are recorded. The study pairs clinical outcome data with in vitro synergy testing of isolates and sequencing of patients' gut microbiota to identify microbial fingerprints associated with treatment response. Investigators will correlate antimicrobial regimens, in vitro synergy results, microbiome profiles, and clinical outcomes to look for patterns that predict benefit from combination therapy.
Who should consider this trial
Good fit: Adults (≥18 years) with monomicrobial Enterococcus faecalis bloodstream infection who receive at least five days of an in vitro–active antibiotic (with or without a synergistic drug) and can provide informed consent.
Not a fit: Patients who die within three days of bacteremia, those with concomitant or polymicrobial infections, or those with complicated EF infections such as endocarditis are unlikely to benefit from this study's findings.
Why it matters
Potential benefit: If successful, the study could clarify whether combination antibiotic therapy lowers mortality or complications and uncover microbiome markers to help guide personalized treatment.
How similar studies have performed: Previous in vitro studies and older uncontrolled clinical reports have suggested synergy with combination regimens, but contemporary, well-controlled clinical evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (≥18 years) * Monomicrobial EF-BSI * Receipt of ≥ 5 days of at least one in vitro active drug (ampicillin, amoxicillin/clavulanate, ampicillin/sulbactam, piperacillin, vancomycin, teicoplanin, daptomycin and linezolid) with or without a synergistic drug (ceftriaxone, gentamycin, streptomycin), at common suggested dosages for EF-BSI in empirical or definitive therapy * Written informed consent Exclusion Criteria: * Short term (within 3 days from BSI) mortality * Other concomitant infection
Where this trial is running
Bologna, Bologna and 3 other locations
- Ospedale Maggiore "Carlo Alberto Pizzardi" di Bologna — Bologna, Bologna, Italy (Recruiting)
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
- Azienda Ospedaliero Universitaria di Catanzaro "Mater Domini" — Catanzaro, Catanzaro, Italy (Recruiting)
- Humanitas Research Hospital — Milan, Milano, Italy (Recruiting)
Study contacts
- Principal investigator: Maddalena Giannella, MD PhD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Maddalena Giannella, MD PhD
- Email: maddalena.giannella@unibo.it
- Phone: +39 0512143199
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.