RecruitingPhase 4NCT06423898

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)


Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Enrollment

284 participants

Start Date

Oct 9, 2024

Study Type

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

Min Age: 18 Years

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAmpicillin plus ceftriaxone in continuous infusion

Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis

DRUGAmpicillin 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06423898


Related Trials