Actively Recruiting

Age: 18Years +
All Genders
ID06833593

Efficacy of Optimized Antimicrobial Combination Therapy for Treatment of Enterococcus Faecalis Bacteremia and Identification of Intestinal Microbiota Signature

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-12-03

510

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult (≥18 years)
  • Monomicrobial Enterococcus faecalis bloodstream infection
  • Received at least 5 days of at least one in vitro active antibiotic (such as ampicillin, vancomycin, daptomycin) with or without a synergistic drug (like ceftriaxone, gentamycin)
  • Provided written informed consent
Not Eligible

You will not qualify if you...

  • Death within 3 days from bloodstream infection
  • Presence of other simultaneous infections

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Up to 6 weeks from enrollment

Participants who have Enterococcus faecalis bloodstream infection are observed to evaluate clinical cure, improvement, and treatment outcomes with monotherapy or combination therapy.

Regular visits during the 6 weeks following enrollment

Long-term Monitoring

Duration - Up to 3 months from enrollment

Participants undergo genotypic and phenotypic analysis of E. faecalis and gut microbiota fingerprinting to correlate microbiota composition with treatment outcomes and clinical prognosis.

Follow-up visits during the 3 months after treatment

Trial Site Locations

Total: 4 locations

1

Ospedale Maggiore "Carlo Alberto Pizzardi" di Bologna

Bologna, Bologna, Italy, 40133

Actively Recruiting

2

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy, 40138

Actively Recruiting

3

Azienda Ospedaliero Universitaria di Catanzaro "Mater Domini"

Catanzaro, Catanzaro, Italy, 88100

Actively Recruiting

4

Humanitas Research Hospital

Milan, Milano, Italy, 20089

Actively Recruiting

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Research Team

M

Maddalena Giannella, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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