FOUR-SIX TRIAL for the Treatment of Enterococcal Endocarditis
NCT ID: NCT05398289
Last Updated: 2023-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
130 participants
INTERVENTIONAL
2024-01-01
2026-09-01
Brief Summary
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AIM 1: To evaluate a 4-week duration of antibiotic therapy versus a 6-week duration according to international guidelines.
AIM 2: Second aim is to evaluate the PK/PD of antimicrobials in relation to the probability of target attainment (PTA) of optimal exposure against enterococci.
AIM 3: Finally, we will analyze the bactericidal activities of antibiotic combinations used in patients with IE and the survival of the subgroup of patients who underwent surgery.
Open-label, multicenter, randomized, non-inferiority trial to be conducted in a 3-year period. The institutional review board at each site will approve the protocol, and all patients or their authorized representatives will provide written informed consent. Eligible patients will be 18 years of age or older with a documented IE due to enterococcal strains, according to the modified Duke criteria.
63 patients in each of the two arms. The study will be conducted at Italian sites. Data on demographic characteristics, comorbidities, antibiotic and concomitant therapies will be collected. Baseline treatments will be defined according to the patients' pharmacological history. IE will be defined according to modified Duke criteria. Antibiotic treatment, indications and timing of surgery will be based on the 2015 American Heart Association and European Society of Cardiology guidelines.
Blood samples for determining antibiotic concentrations of ampicillin, gentamicin, vancomycin, daptomycin and linezolid will be collected at predetermined times in order to allow estimation of PK/PD.
Randomization:
1. 4-week duration of antibiotic therapy
2. standard 6-week duration of antibiotic therapy The intention-to-treat population (ITT) will include all randomized patients. The modified intention-to-treat population (mITT) will include all randomized patients receiving at least one dose of study medication. The clinically evaluable (CE) population will include ITT patients demonstrating sufficient adherence to study protocol.
Primary endpoint: non-inferiority of a 4-week course in terms of outcome at 60 days.
Secondary endpoints: microbiological eradication, pharmacological concentrations of antibiotic regimens, patients undergoing surgery, duration of therapy according with resistance profile of enterococcal species.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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4-week duration of antibiotic therapy
4-week duration of antibiotic therapy
The aim is to show non-inferiority of a 4-week duration of antibiotic therapy versus a standard 6-week duration according to international guidelines
standard 6-week duration of antibiotic therapy
6-week duration of antibiotic therapy
The aim is to show non-inferiority of a 4-week duration of antibiotic therapy versus a standard 6-week duration according to international guidelines
Interventions
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4-week duration of antibiotic therapy
The aim is to show non-inferiority of a 4-week duration of antibiotic therapy versus a standard 6-week duration according to international guidelines
6-week duration of antibiotic therapy
The aim is to show non-inferiority of a 4-week duration of antibiotic therapy versus a standard 6-week duration according to international guidelines
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University Magna Graecia
OTHER
Responsible Party
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Alessandro Russo
Associate Professor
Central Contacts
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Other Identifiers
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FST_2022
Identifier Type: -
Identifier Source: org_study_id
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