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

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status and phase: Enrolling; Phase 4

Conditions: Endocarditis, Infective

Treatments: Drug: Ampicillin plus ceftriaxone in continuous infusion; Drug: Ampicillin plus ceftriaxone in intermittent infusion of 14 days, after which the treatment may be changed

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06423898

DOBLEI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 284 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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284 participants in 2 patient groups

Continuous intravenous antibiotic infusion

Experimental group

Description:

Ampicillin 12g/24h plus ceftriaxone 4g/12h continuous infusion. The duration of treatment will be 42 days.

Treatment:

Drug: Ampicillin plus ceftriaxone in continuous infusion

Standard treatment

Active Comparator group

Description:

Ampicillin 2g/4h plus ceftriaxone 2g/12h intermittent infusion for a minimum of 14 days. Starting on day 14 of treatment, if the patient is discharged from the hospital, the following treatments will be permitted: 1. Intravenous treatment in TADE programs according to the following regimens: 1. Ampicillin 2g/4h plus ceftriaxone 2g/12h as an intermittent infusion 2. Teicoplanin 10-12mg/kg/24h 3. Daptomycin 10-12mg/kg/24h 4. Dalbavancin: Initial dose: 2 doses of 1500mg every 2 weeks. Maintenance dose: 1500mg every 15days. 5. Linezolid: 600mg/12hours 2. Oral treatment according to the following regimens: 1. Amoxicillin 1 g/6h + Moxifloxacin 400mg/24h. 2. Amoxicillin 1 g/6h + Linezolid 600 mg/12h. 3. Amoxicillin 1 g/6h + Rifampin 600 mg/12h. 4. Linezolid 600 mg/12h + Moxifloxacin 400mg/24h. 5. Linezolid 600 mg/12h + Rifampin 600 mg/12h. The duration of treatment will be 42 days

Treatment:

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