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

ConditionEndocarditis, Infective
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación Pública Andaluza para la gestión de la Investigación en Sevilla

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Adult patients

Possible or definitive diagnosis of infective endocarditis due to Enterococcus faecalis

Signed informed consent of patients

Disqualifiers

Allergy to penicillins or cephalosporins

Pregnancy and lactation

Polymicrobial infection including microorganisms different to E. faecalis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ampicillin plus ceftriaxone in continuous infusion

    Drug

    Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis

  • Ampicillin plus ceftriaxone in intermittent infusion of 14 days, after which the treatment may be changed

    Drug

    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.

Treatment groups

284 Participants
are divided into 2 treatment groups
Group A: Continuous intravenous antibiotic infusionExperimental treatment 1 intervention
Group B: Standard treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical failure

It is defined as follow: i) Confirmed recurrence of E. faecalis infective endocarditis, ii) all-cause mortality. A composite primary endpoint has been chosen to include both a very clinically relevant variable and a hard variable such as survival

Time frame
One year after the end of the treatment

Secondary outcomes

1

Therapeutic failure

Number of deaths

Time frame
Up to 12 months after treatment administration
2

Cardiac surgeries

Number of unplanned cardiac surgeries

Time frame
Up to 12 months after treatment administration
3

Readmissions

Number of unplanned readmissions

Time frame
Up to 12 months after treatment administration
4

Adverse events

Number of medication-related adverse events

Time frame
From randomisation until 30 days after the last dose administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Lead sponsor

Spanish Clinical Research Network - SCReN

Collaborator

Source ClinicalTrials.gov
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