Actively Recruiting
Study of Antimicrobial Treatments for Enterococcus Faecalis Bloodstream Infection and Gut Microbiota Changes
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-12-03
510
Participants Needed
4
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of monotherapy versus combination antimicrobial treatments for patients with non-complicated Enterococcus faecalis bloodstream infection EF-BSI. This observational national multicenter study also aims to identify the gut microbiota fingerprint linked to EF-BSI and its relationship to antimicrobial treatments and patient outcomes. Enterococcus faecalis is a common gut bacterium that can cause serious bloodstream infections, and this study seeks to improve treatment strategies and understand the role of gut bacteria. The study compares appropriate single-drug therapy to combination antibiotic treatments, including drugs such as ampicillin, daptomycin, and newer cephalosporins like ceftaroline and ceftobiprole. It also assesses the clinical value of in vitro synergy tests that evaluate how well drug combinations work together. Participants receive at least five days of active antibiotic treatment, either alone or combined with synergistic drugs, following usual dosing guidelines. The study collects bacterial strains and monitors clinical outcomes up to six weeks after enrollment. Participants are monitored through bacterial culture analyses and gut microbiota assessments, with follow-up lasting up to three months. Researchers analyze genotypic and phenotypic traits of the bacteria and correlate these findings with treatment outcomes. The primary outcomes include clinical cure rates and validation of synergy testing. Secondary outcomes investigate the diversity of bacterial strains and changes in gut microbiota composition. This study provides detailed observation of treatment effects and gut microbiome changes in adults with EF-BSI.
CONDITIONS
Brief Title
Antimicrobial Combination Therapy for Treatment of Enterococcus Faecalis Bacteremia
Research Team
M
Maddalena Giannella, MD PhD
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