Ignite Creation Date:
2024-05-06 @ 1:37 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04070820
Status:
UNKNOWN
Last Update Posted:
2020-03-25
First Post:
2019-08-22
Brief Title:
Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter Observational Study
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Combination Treatment for Enterococcus Faecalis Bacteremia a Prospective Multicenter Observational Study
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1420-bed tertiary care University Hospital in Bologna with an average of 72000 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
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 1420-bed tertiary care University Hospital in Bologna with an average of 72000 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None