Bloodstream Infection Clinical Trial
Official title:
"Combination Treatment for Enterococcus Faecalis Bacteremia: a Prospective, Multicenter, Observational Study"
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.
n/a
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