Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.

Last updated: July 24, 2025
Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Overall Status: Active - Recruiting

Phase

4

Condition

Heart Disease

Cardiovascular Disease

Cardiac Disease

Treatment

Experimental regimen

Ampicillin plus ceftriaxone in continuous infusion

Control regimen

Clinical Study ID

NCT06423898
DOBLEI
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Adult patients

  • Possible or definitive diagnosis of infective endocarditis due to Enterococcusfaecalis

  • Signed informed consent of patients

Exclusion

Exclusion Criteria:

  • Allergy to penicillins or cephalosporins

  • Pregnancy and lactation

  • Polymicrobial infection including microorganisms different to E. faecalis

Study Design

Total Participants: 284
Treatment Group(s): 4
Primary Treatment: Experimental regimen
Phase: 4
Study Start date:
October 09, 2024
Estimated Completion Date:
December 31, 2028

Study Description

The aim of the study is to prove that the continuous infusion of antibiotic treatment for the patients with Enterococcus faecalis infective endocarditis is as effective and safe as the standard treatment. The continuous infusion modality of treatment is expected to provide numerous benefits for individual patients, global health, and for the National Health Care System by reducing to hospital stays from 4-6 weeks to approximately 2-3 weeks and hospital-driven complications.

The mortality, rate of serious adverse events, total number of days of antibiotic treatment and days of hospitalization, among others, are included as secondary objectives.

This is a pragmatic study as the number or visits performed for the study are similar to the normal clinical follow-up for this patients. Final contact and final visit for the study will be performed at 365 days after the 42 days of treatment.

Connect with a study center

  • Hospital Universitario de Álava

    Alava, 01009
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Barakaldo, 48903
    Spain

    Site Not Available

  • Hospital Clínico de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario de Donostia

    Donostia, 20014
    Spain

    Site Not Available

  • Hospital Universitario Virgen de las Nieves

    Granada, 18014
    Spain

    Site Not Available

  • Hospital Universitario de Canarias

    La Laguna, 38320
    Spain

    Active - Recruiting

  • Hospital San Pedro

    Logroño, 26006
    Spain

    Site Not Available

  • Hospital Clínico San Carlos

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario La Paz

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Puerta del Hierro

    Madrid, 28222
    Spain

    Site Not Available

  • Hospital Universitario Regional de Málaga

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitari MútuaTerrassa

    Terrassa, 08221
    Spain

    Site Not Available

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