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Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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.
Official title: Efficacy and Safety of Ampicillin and Ceftriaxone Continuous Infusion Versus Standard Therapy for the Treatment of Enterococcus Faecalis Infective Endocarditis (DOβLEI Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
284
Start Date
2024-10-09
Completion Date
2028-12-31
Last Updated
2025-07-25
Healthy Volunteers
No
Conditions
Interventions
Ampicillin plus ceftriaxone in continuous infusion
Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis
Ampicillin plus ceftriaxone in intermittent infusion of 14 days, after which the treatment may be changed
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)
Hospital Universitario de Álava
Alava, Spain
Hospital Universitario de Cruces
Barakaldo, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Clínico de Barcelona
Barcelona, Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital San Pedro
Logroño, Spain
Hospital Universitario Gregorio Marañón
Madrid, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Universitario Puerta del Hierro
Madrid, Spain
Hospital Universitario Regional de Málaga
Málaga, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitari MútuaTerrassa
Terrassa, Spain