Clinical trial NCT04070820: Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"
Official title: "Combination Treatment for Enterococcus Faecalis Bacteremia: a Prospective, Multicenter, Observational Study"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Enterococcal Bacteraemia
Enterococcus Faecalis Infection
Enterococcal Endocarditis
Bloodstream Infection
Keywords: Combination therapy
Bloodstream Infection
Enterococcus faecalis Infection
Endocarditis
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive, unselected patients with a first episode of monomicrobial EF-BSI will be screened for study inclusion

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adult (\>18 years)
* First 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 outcomes:
measure: Survival
timeFrame: End of Treatment, at least 2 weeks from first negative follow-up bloodculture
measure: Body temperature (Celsius degrees)
timeFrame: End of Treatment, at least 2 weeks from first negative follow-up bloodculture
measure: Sequential Organ Failure Assessment (SOFA) Score
timeFrame: End of Treatment, at least 2 weeks from first negative follow-up bloodculture
measure: Blood cultures
timeFrame: End of Treatment, at least 2 weeks from first negative follow-up bloodculture
measure: Blood cultures
timeFrame: 90 days from End of Treatment
measure: Antibiotic therapy
timeFrame: 90 days from End of Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Infectious Disease Unit - S.Orsola Malpighi Hospital
Study officials:
affiliation: Dipartimento di Scienze mediche e chirurgiche, Alma Mater-University of Bologna
name: Michele Bartoletti
role: PRINCIPAL_INVESTIGATOR
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