Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"

March 23, 2020 updated by: Michele Bartoletti, University of Bologna

"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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy
        • Recruiting
        • Infectious Disease Unit - S.Orsola Malpighi Hospital
        • Contact:
          • Michele Bartoletti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All consecutive, unselected patients with a first episode of monomicrobial EF-BSI will be screened for study inclusion

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Investigators

  • Principal Investigator: Michele Bartoletti, Dipartimento di Scienze mediche e chirurgiche, Alma Mater-University of Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 24, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EfFAECT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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