Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Italy / NCT06833593
Recruiting Observational

Antimicrobial Combination Therapy for Treatment of Enterococcus Faecalis Bacteremia

NCT06833593 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2021-02-06
Last updated
2025-12-03

Condition(s) studied

Enterococcus Faecalis InfectionBlood Stream InfectionGut Microbiomes

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Evaluation of Clinical Cure and Improvement Rates for EF-BSI — Up to 6 weeks from patient enrollment, with bacterial strains isolated at baseline
    The clinical cure and improvement rates will be evaluated for patients undergoing mono therapy and combination therapy for EF-BSI.
  • Comparison of Clinical Outcomes Between Mono Therapy and Combination Therapy — Up to 6 weeks from patient enrollment, with bacterial strains isolated at baseline
    A comparison of clinical outcomes between mono therapy and combination therapy in terms of clinical cure, improvement, and any adverse events.
  • Validation of In Vitro Synergy Tests — Up to 6 weeks from patient enrollment, with bacterial strains isolated at baseline
    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.

Trial sites (4)

FacilityCityRegionStatus
Ospedale Maggiore "Carlo Alberto Pizzardi" di Bologna Bologna Bologna Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna Recruiting
Azienda Ospedaliero Universitaria di Catanzaro "Mater Domini" Catanzaro Catanzaro Recruiting
Humanitas Research Hospital Milan Milano Recruiting

More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Italy

Radiological Diagnostics in Patients With Deep Endometriosis Recruiting
An Italian Multicentric Retrospective Observational Study to Assess Effectiveness and Safety of the Combination of Tafasitamab and Lenalidomide in Diffuse Large B-cell Lymphoma Patients Treated Under Named Patient Program Recruiting
Phenotypic and Genotypic Characterisation of a Large, Multicentre Italian Cohort of 46, XY DSD Patients Recruiting
Multi-Dimensional Genomic Dissection of Ring Chromosome 14 Syndrome Active, not recruiting
Study of the Characteristics of the Vascular Wall in Pediatric Age Recruiting

Other trials for the same condition

Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06833593 on ClinicalTrials.gov ↗ ← All trials in Italy