Combination Treatment for Enterococcus Faecalis Bacteriemia Multicenter, Observational Study"

NCT04070820 | Unknown

• 1 other identifier: EfFAECT
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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. 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. 2.To compare the efficacy of combination treatment (vs monotherapy) in the following subgroup of patients:
3. 3.To validate the NOVA score as a predictor of enterococcal endocarditis in a large multicentre cohort of patients with EF-BSI.
4. 4.To estimate optimal duration of treatment of EF-BSI in patients without endocarditis.
5. 5.To evaluate the rate of 90-day development of Clostridium difficile infection.

Conditions

Enterococcal Bacteraemia; Enterococcus Faecalis Infection; Enterococcal Endocarditis; Bloodstream Infection

Keywords

Combination therapy; Bloodstream Infection; Enterococcus faecalis Infection; Endocarditis

Outcome Measures

Primary Outcomes (6)

• Survival

  Patient alive

  End of Treatment, at least 2 weeks from first negative follow-up bloodculture

• Body temperature (Celsius degrees)

  Fever resolution

  End of Treatment, at least 2 weeks from first negative follow-up bloodculture

• Sequential Organ Failure Assessment (SOFA) Score

  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

  Follow-up Blood cultures negative for E. faecalis

  End of Treatment, at least 2 weeks from first negative follow-up bloodculture

• Blood cultures

  No relapse of EF-BSI

  90 days from End of Treatment

• Antibiotic therapy

  No need to modify initial therapy

  90 days from End of Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Short term (within 3 days from BSI) mortality
• Other concomitant infection

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

Infectious Disease Unit - S.Orsola Malpighi Hospital

Bologna, Italy

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Sepsis; Endocarditis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Michele Bartoletti

  Dipartimento di Scienze mediche e chirurgiche, Alma Mater-University of Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele Bartoletti

CONTACT

0512143199; m.bartoletti@unibo.it

Elena Rosselli Del Turco

CONTACT

0512142861; elena.rosselli@studio.unibo.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)