Efficacy and Safety of Ampicillin and Ceftriaxone Continuous Infusion Versus Standard Therapy for the Treatment of Enterococcus Faecalis Infective Endocarditis (DOβLEI Study)
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Adult patients
• Possible or definitive diagnosis of infective endocarditis due to Enterococcus faecalis
• Signed informed consent of patients
Locations
Other Locations
Spain
Hospital Universitario de Álava
RECRUITING
Alava
Hospital Universitario de Cruces
ACTIVE_NOT_RECRUITING
Barakaldo
Hospital Clínico de Barcelona
NOT_YET_RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Universitario de Donostia
ACTIVE_NOT_RECRUITING
Donostia / San Sebastian
Hospital Universitario Virgen de las Nieves
ACTIVE_NOT_RECRUITING
Granada
Hospital San Pedro
ACTIVE_NOT_RECRUITING
Logroño
Hospital Clínico San Carlos
NOT_YET_RECRUITING
Madrid
Hospital Universitario Gregorio Marañón
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Puerta del Hierro
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Regional de Málaga
ACTIVE_NOT_RECRUITING
Málaga
Hospital Universitario Virgen de la Victoria
ACTIVE_NOT_RECRUITING
Málaga
Hospital Universitario de Canarias
RECRUITING
San Cristóbal De La Laguna
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Hospital Universitario Virgen Macarena
ACTIVE_NOT_RECRUITING
Seville
Hospital Universitari MútuaTerrassa
ACTIVE_NOT_RECRUITING
Terrassa
Contact Information
Primary
Laura Herrera Hidalgo, MD-PhD
lauraherrerahidalgo@gmail.com
+34955013414
Backup
Clara M Rosso Fernández, MD-PhD
claram.rosso.sspa@juntadeandalucia.es
+34955013414
Time Frame
Start Date: 2024-10-09
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 284
Treatments
Experimental: Continuous intravenous antibiotic infusion
Ampicillin 12g/24h plus ceftriaxone 4g/12h continuous infusion. The duration of treatment will be 42 days.
Active_comparator: Standard treatment
Ampicillin 2g/4h plus ceftriaxone 2g/12h intermittent infusion for a minimum of 14 days. Starting on day 14 of treatment, if the patient is discharged from the hospital, the following treatments will be permitted:~1. Intravenous treatment in TADE programs according to the following regimens:~ 1. Ampicillin 2g/4h plus ceftriaxone 2g/12h as an intermittent infusion~ 2. Teicoplanin 10-12mg/kg/24h~ 3. Daptomycin 10-12mg/kg/24h~ 4. Dalbavancin: Initial dose: 2 doses of 1500mg every 2 weeks. Maintenance dose: 1500mg every 15days.~ 5. Linezolid: 600mg/12hours~2. Oral treatment according to the following regimens:~ 1. Amoxicillin 1 g/6h + Moxifloxacin 400mg/24h.~ 2. Amoxicillin 1 g/6h + Linezolid 600 mg/12h.~ 3. Amoxicillin 1 g/6h + Rifampin 600 mg/12h.~ 4. Linezolid 600 mg/12h + Moxifloxacin 400mg/24h.~ 5. Linezolid 600 mg/12h + Rifampin 600 mg/12h. The duration of treatment will be 42 days
Related Therapeutic Areas
Sponsors
Collaborators: Spanish Clinical Research Network - SCReN
Leads: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla