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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Ampicillin plus ceftriaxone in continuous infusion
  Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis
• Препарат 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,

Первичные конечные точки

• Clinical failure [Срок оценки: One year after the end of the treatment]

Вторичные конечные точки (12)

• Therapeutic failure [Срок оценки: Up to 12 months after treatment administration]
• Cardiac surgeries [Срок оценки: Up to 12 months after treatment administration]
• Readmissions [Срок оценки: Up to 12 months after treatment administration]
• Adverse events [Срок оценки: From randomisation until 30 days after the last dose administration]
• Antibiotic treatment days [Срок оценки: Up to 12 months after treatment administration]
• Outpatient Parenteral Antimicrobial Therapy [Срок оценки: Up to 12 months after treatment administration]
• Healthcare-associated infections [Срок оценки: Up to 12 months after treatment administration]
• Recurrence [Срок оценки: Up to 12 months after treatment administration]
• Minimum free serum concentration [Срок оценки: Day 14]
• Steady-state plasma concentration [Срок оценки: Day 14]
• Pharmacokinetic parameters [Срок оценки: Day 14]
• Minimum Inhibitory Concentration [Срок оценки: Day 14]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Испания · 18 центров

• 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
• … и ещё 10 центров

Идентификаторы

NCT: NCT06423898 · DOBLEI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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