Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.
Efficacy and Safety of Ampicillin and Ceftriaxone Continuous Infusion Versus Standard Therapy for the Treatment of Enterococcus Faecalis Infective Endocarditis (DOβLEI Study)
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
284 participants
Oct 9, 2024
INTERVENTIONAL
Conditions
Summary
Phase IV, open-label, randomized and multicenter clinical trial to prove that patients with Enterococcus faecalis infective endocarditis treated with an antibiotic treatment as a continuous infusion is non-inferior to the standard treatment, usually administered in hospitalized patients.
Eligibility
Inclusion Criteria3
- Adult patients
- Possible or definitive diagnosis of infective endocarditis due to Enterococcus faecalis
- Signed informed consent of patients
Exclusion Criteria3
- Allergy to penicillins or cephalosporins
- Pregnancy and lactation
- Polymicrobial infection including microorganisms different to E. faecalis
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Interventions
Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis
Ampicillin plus ceftriaxone as an intermittent infusion for a minimum of 14 days. After, if the patient is discharged from the hospital, the following treatments, until the 42-day treatment period is completed: 1. Intravenous treatment according to the following regimens: Ampicillin plus ceftriaxone as an intermittent infusion, teicoplanin, daptomycin, dalbavancin or linezolid. 2. Oral treatment according to the following regimens: amoxicillin plus moxifloxacin, amoxicillin plus linezolid, amoxicillin plus rifampin, linezolid plus moxifloxacin or linezolid plus rifampin.
Locations(18)
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NCT06423898