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Recruiting NCT06423898

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

Phase IV Interventional Endocarditis, Infective

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ampicillin plus ceftriaxone in continuous infusion, Ampicillin plus ceftriaxone in intermittent infusion of 14 days, after which the treatment may be changed.
Who it may be relevant to
Registry conditions: Endocarditis, Infective. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Ampicillin and Ceftriaxone Continuous Infusion Versus Standard Therapy for the Treatment of Enterococcus Faecalis Infective Endocarditis (DOβLEI Study)

Overview

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.

Detailed 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.

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,

Primary outcome measures

  • Clinical failure [Time frame: One year after the end of the treatment]
Secondary outcome measures (12)
  • Therapeutic failure [Time frame: Up to 12 months after treatment administration]
  • Cardiac surgeries [Time frame: Up to 12 months after treatment administration]
  • Readmissions [Time frame: Up to 12 months after treatment administration]
  • Adverse events [Time frame: From randomisation until 30 days after the last dose administration]
  • Antibiotic treatment days [Time frame: Up to 12 months after treatment administration]
  • Outpatient Parenteral Antimicrobial Therapy [Time frame: Up to 12 months after treatment administration]
  • Healthcare-associated infections [Time frame: Up to 12 months after treatment administration]
  • Recurrence [Time frame: Up to 12 months after treatment administration]
  • Minimum free serum concentration [Time frame: Day 14]
  • Steady-state plasma concentration [Time frame: Day 14]
  • Pharmacokinetic parameters [Time frame: Day 14]
  • Minimum Inhibitory Concentration [Time frame: Day 14]

Eligibility criteria

Inclusion criteria

  • Adult patients
  • Possible or definitive diagnosis of infective endocarditis due to Enterococcus faecalis
  • Signed informed consent of patients

Exclusion criteria

  • Allergy to penicillins or cephalosporins
  • Pregnancy and lactation
  • Polymicrobial infection including microorganisms different to E. faecalis

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 18 centers
  • Hospital Universitario de Álava — Alava
  • Hospital Universitario de Cruces — Barakaldo
  • Hospital Universitario Vall d'Hebron — Barcelona
  • Hospital Clínico de Barcelona — Barcelona
  • Hospital Universitario de Donostia — Donostia / San Sebastian
  • Hospital Universitario Virgen de las Nieves — Granada
  • Hospital San Pedro — Logroño
  • Hospital Universitario Gregorio Marañón — Madrid
  • … and 10 more centers

Identifiers

NCT: NCT06423898 · DOBLEI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗