Clinical trial NCT06423898: Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.
Official title: Efficacy and Safety of Ampicillin and Ceftriaxone Continuous Infusion Versus Intermittent Infusion for the Treatment of Enterococcus Faecalis Infective Endocarditis (DOBLEI)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Endocarditis, Infective
Keywords: Endocarditis, Infective
Enterococcus faecalis
Antibiotics
Outpatient Infusion Therapies
Outpatient Care
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Spanish Clinical Research Network - SCReN
First posted: 2024-05-21
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Randomized 1:1 to experimental group (continuous infusion arm) or control group (intermittent infusion arm)
Primary purpose: TREATMENT

Brief 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 intermittent infusion regimen, 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 traditional intermittent infusion. 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.

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

Primary outcomes:
measure: Clinical failure
timeFrame: One year after the end of the treatment
Secondary outcomes:
measure: Therapeutic failure
timeFrame: Up to 12 months after treatment administration
measure: Treatment switching
timeFrame: 42 days
measure: Cardiac surgeries
timeFrame: Up to 12 months after treatment administration
measure: Readmissions
timeFrame: Up to 12 months after treatment administration
measure: Serious adverse events
timeFrame: From randomisation until 30 days after the last dose administration
measure: Antibiotic treatment days
timeFrame: Up to 12 months after treatment administration
measure: Outpatient Parenteral Antimicrobial Therapy
timeFrame: Up to 12 months after treatment administration
measure: Healthcare-associated infections
timeFrame: Up to 12 months after treatment administration
measure: Recurrence
timeFrame: Up to 12 months after treatment administration
measure: Minimum free serum concentration
timeFrame: Day 14
measure: Steady-state plasma concentration
timeFrame: Day 14
measure: Pharmacokinetic parameters
timeFrame: Day 14
measure: Minimum Inhibitory Concentration
timeFrame: Day 14
Other outcomes:
Locations:
city: Alava
country: Spain
facility: Hospital Universitario de Álava
city: Barakaldo
country: Spain
facility: Hospital Universitario de Cruces
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clínico de Barcelona
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias
city: Logroño
country: Spain
facility: Hospital San Pedro
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Puerta del Hierro
city: Málaga
country: Spain
facility: Hospital Universitario Regional de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Terrassa
country: Spain
facility: Hospital Universitari MútuaTerrassa
Study officials:
affiliation: Fundación para la Gestión de la Investigación en Salud de Sevilla
name: HUVR Cesar Arístides de Alarcón González, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: