Antimicrobial Combination Therapy for Treatment of Enterococcus Faecalis Bacteremia

NCT06833593 | Recruiting

• 2 other identifiers: Micro-EFfAECT"Ricerca Finalizzata 2019"
• Study Type: observational
• Target: 510
• Locations: 1 country
• Sites: 4

Brief Summary

Prospective, multicenter, national, observational pharmacological study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated Enterococcus faecalis (EF) bloodstream infection (BSI) and identification of gut microbiota fingerprint of patients with EF-BSI correlated to antimicrobial treatment and clinical outcome

Conditions

Enterococcus Faecalis Infection; Blood Stream Infection; Gut Microbiomes

Keywords

Enterococcus faecalis bloodstream infection; Human tissue analysis in vitro; Gut microbiota analysis; Enterococcus faecalis genomic analysis

Outcome Measures

Primary Outcomes (3)

• Evaluation of Clinical Cure and Improvement Rates for EF-BSI

  The clinical cure and improvement rates will be evaluated for patients undergoing mono therapy and combination therapy for EF-BSI.

  Up to 6 weeks from patient enrollment, with bacterial strains isolated at baseline

• Comparison of Clinical Outcomes Between Mono Therapy and Combination Therapy

  A comparison of clinical outcomes between mono therapy and combination therapy in terms of clinical cure, improvement, and any adverse events.

  Up to 6 weeks from patient enrollment, with bacterial strains isolated at baseline

• Validation of In Vitro Synergy Tests

  To validate the in vitro synergy or antagonism of antimicrobial combinations tested in the laboratory, correlating these results with clinical outcomes. In vitro synergy tests will be conducted to evaluate the interaction between antimicrobial combinations, and the results of these tests will be correlated with the clinical outcomes of the patients.

  Up to 6 weeks from patient enrollment, with bacterial strains isolated at baseline

Secondary Outcomes (5)

• Genotypic Analysis of E. faecalis

  From enrollment to the end of the follow-up at three months

• Phylogenetic Relationship and Clonal Diversity

  From enrollment to the end of the follow-up at three months

• Correlation Between Genotypic/Phenotypic Traits and Clinical Outcome

  From enrollment to the end of the follow-up at three months

• Gut Microbiota Fingerprint Analysis in EF-BSI Patients

  From enrollment to the end of the follow-up at three months

• Intestinal Microbiota Composition and Its Correlation with Treatment Outcomes

  From enrollment to the end of the follow-up at three months

Study Arms (1)

Adult with Enterococcus faecalis monomicrobial bloodstream infection

Adult patients with primary Enterococcus faecalis monomicrobial bloodstream infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients (≥ 18 years) with primary Enterococcus faecalis monomicrobial bloodstream infection

You may qualify if:

• 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

You may not qualify if:

• Short term (within 3 days from BSI) mortality
• Other concomitant infection

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (4)

Ospedale Maggiore "Carlo Alberto Pizzardi" di Bologna

Bologna, Bologna, 40133, Italy

RECRUITING

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Azienda Ospedaliero Universitaria di Catanzaro "Mater Domini"

Catanzaro, Catanzaro, 88100, Italy

RECRUITING

Humanitas Research Hospital

Milan, Milano, 20089, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* isolated bacterial strains for genomic analysis * stool samples for gut microbiota analysis

Study Officials

• Maddalena Giannella, MD PhD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maddalena Giannella, MD PhD

CONTACT

+39 0512143199; maddalena.giannella@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: February 19, 2025
• Study Start: February 6, 2021
• Primary Completion (Estimated): September 26, 2026
• Study Completion (Estimated): September 26, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-10

Locations

IT (4)