An observational study in Enterococcal Bacteraemia, Enterococcus Faecalis Infection and Enterococcal Endocarditis, sponsored by University of Bologna. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-25.
Sponsored by University of Bologna · Observational
Prospective, multicenter, observational study on the evaluation of efficacy of appropriate monotherapy vs combination treatment for non-complicated Enterococcus faecalis bloodstream infection (EF-BSI).
The aims of our study are:
Primary:
To compare the efficacy of appropriate monotherapy vs combination treatment for EF-BSI, according to standard of care.
Secondary:
To compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients:
A. Patients with low versus high risk of endocarditis according with the "Number of positive blood cultures, Origin of the bacteremia, previous Valve disease, Auscultation of heart murmur (NOVA) score".
B. Patients with metastatic septic localizations. C. Patients with catheter-related BSI. D. Patients with indwelling cardiovascular device or prosthetic valve.
The promoting center is S. Orsola-Malpighi Hospital is a 1,420-bed tertiary care University Hospital in Bologna with an average of 72,000 admissions per year. A dedicate team of Infectious Diseases (ID) specialists is active in the promoting center. Investigators of this team have already coordinated multicenter studies on infections topics. Centers from other countries will be invited to participate by email, they will be ask to fulfil an agreement form.
All consecutive, unselected patients with monomicrobial EF-BSI will be screened for study inclusion. We expect to enroll about 500 patients.
Period of data collection will be from september 2019 to 31th December 2020.
6,688 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 500 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →University of Bologna is the lead sponsor of 153 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive, unselected patients with a first episode of monomicrobial EF-BSI will be screened for study inclusion
Exclusion Criteria:
Survival
Patient alive
Time frame: End of Treatment, at least 2 weeks from first negative follow-up bloodculture
Body temperature (Celsius degrees)
Fever resolution
Time frame: End of Treatment, at least 2 weeks from first negative follow-up bloodculture
Sequential Organ Failure Assessment (SOFA) Score
Stable or improved SOFA score. Total SOFA score ranges from 0 to 24 points. Total SOFA score consist of the sum of individual score of following items: Respiratory System (PaO2/FiO2), Cardiovascular system (Mean Arterial Pressure or administration vasopressure required), Newrvous System (Glasgow Coma Scale), Liver (bilirubin), Coagulation (platelets), Kidneys (creatinine). Each items receive a score ranging from 0 to 4 pt.
Time frame: End of Treatment, at least 2 weeks from first negative follow-up bloodculture
Blood cultures
Follow-up Blood cultures negative for E. faecalis
Time frame: End of Treatment, at least 2 weeks from first negative follow-up bloodculture
Blood cultures
No relapse of EF-BSI
Time frame: 90 days from End of Treatment
Antibiotic therapy
No need to modify initial therapy
Time frame: 90 days from End of Treatment
Plan to share: No
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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University of Bologna