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

NCT06423898 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2025-07-25

No results posted yet for this 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.

Conditions

  • Endocarditis, Infective

Interventions

DRUG

Ampicillin plus ceftriaxone in continuous infusion

Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis

DRUG

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.

Sponsors & Collaborators

  • Spanish Clinical Research Network - SCReN

    collaborator NETWORK

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • HUVR Cesar Arístides de Alarcón González, MD-PhD · Fundación para la Gestión de la Investigación en Salud de Sevilla

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-09
Primary Completion
2027-07-31
Completion
2028-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06423898 on ClinicalTrials.gov