Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"

Sponsor

University of Bologna (Other)

Overall Status

Unknown status

CT.gov ID

NCT04070820

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

27.8

Patients Per Site Per Month

Study Details

Study Description

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:

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.
To compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients:

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".
Patients with metastatic septic localizations. C. Patients with catheter-related BSI.
Patients with indwelling cardiovascular device or prosthetic valve.

To validate the NOVA score as a predictor of enterococcal endocarditis in a large multicentre cohort of patients with EF-BSI.
To estimate optimal duration of treatment of EF-BSI in patients without endocarditis.
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.

Condition or Disease	Intervention/Treatment	Phase
Enterococcal Bacteraemia Enterococcus Faecalis Infection Enterococcal Endocarditis Bloodstream Infection

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

"Combination Treatment for Enterococcus Faecalis Bacteremia: a Prospective, Multicenter, Observational Study"

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Mar 1, 2021

Outcome Measures

Primary Outcome Measures

Survival [End of Treatment, at least 2 weeks from first negative follow-up bloodculture]
Patient alive
Body temperature (Celsius degrees) [End of Treatment, at least 2 weeks from first negative follow-up bloodculture]
Fever resolution
Sequential Organ Failure Assessment (SOFA) Score [End of Treatment, at least 2 weeks from first negative follow-up bloodculture]
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.
Blood cultures [End of Treatment, at least 2 weeks from first negative follow-up bloodculture]
Follow-up Blood cultures negative for E. faecalis
Blood cultures [90 days from End of Treatment]
No relapse of EF-BSI
Antibiotic therapy [90 days from End of Treatment]
No need to modify initial therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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