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:
1. To compare the impact on clinical outcome of the initial combination therapy in the
subgroup of patients with enterococcal endocarditis. In this case we will evaluate
only the antibiotic treatment administered before the diagnosis of endocarditis
assuming that any case of endocarditis will be treated with a combination therapy.
2. 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.
3. To validate the NOVA score as a predictor of enterococcal endocarditis in a large
multicentre cohort of patients with EF-BSI.
4. To estimate optimal duration of treatment of EF-BSI in patients without
endocarditis.
5. To evaluate the rate of 90-day development of Clostridium difficile infection.
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.