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: Not yet enrolling; Phase 4

Conditions: Endocarditis, Infective

Treatments: Drug: Control regimen; Drug: Experimental regimen

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 intermittent infusion regimen, 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 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.

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 2g/4h plus ceftriaxone 2g/12h intermittently infused. The duration of treatment will be 42 days.

Treatment:

Drug: Experimental regimen

Intermittent intravenous antibiotic infusion

Active Comparator group

Description:

Ampicillin 2g/4h plus ceftriaxone 2g/12h intermittent infusion. The duration of treatment will be 42 days.

Treatment:

Drug: Control regimen