Combination versus single-drug antibiotic treatment for Enterococcus faecalis bloodstream infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.