Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.
- Conditions
- Endocarditis, Infective
- Interventions
- Drug: Control regimenDrug: Experimental regimen
- Registration Number
- NCT06423898
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 284
- Adult patients
- Possible or definitive diagnosis of infective endocarditis due to Enterococcus faecalis
- Signed informed consent of patients
- Allergy to penicillins or cephalosporins
- Pregnancy and lactation
- Polymicrobial infection including microorganisms different to E. faecalis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intermittent intravenous antibiotic infusion Control regimen Ampicillin 2g/4h plus ceftriaxone 2g/12h intermittent infusion. The duration of treatment will be 42 days. Continuous intravenous antibiotic infusion Experimental regimen Ampicillin 2g/4h plus ceftriaxone 2g/12h intermittently infused. The duration of treatment will be 42 days.
- Primary Outcome Measures
Name Time Method Clinical failure One year after the end of the treatment 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
- Secondary Outcome Measures
Name Time Method Antibiotic treatment days Up to 12 months after treatment administration Number of antibiotic treatment days
Minimum Inhibitory Concentration Day 14 Minimum Inhibitory Concentration of ampicillin induced by ceftriaxone in the strains responsible for recurrences and control strains
Cardiac surgeries Up to 12 months after treatment administration Number of unplanned cardiac surgeries
Recurrence Up to 12 months after treatment administration Number of recurrence of Enterococcus faecalis infective endocarditis
Minimum free serum concentration Day 14 Minimum free serum concentration of antibiotics used
Therapeutic failure Up to 12 months after treatment administration Number of deaths
Readmissions Up to 12 months after treatment administration Number of unplanned readmissions
Treatment switching 42 days Number of patient of treatment switching
Serious adverse events From randomisation until 30 days after the last dose administration Number of medication-related adverse events
Outpatient Parenteral Antimicrobial Therapy Up to 12 months after treatment administration Number of Outpatient Parenteral Antimicrobial Therapy
Healthcare-associated infections Up to 12 months after treatment administration Number of healthcare-associated infections
Steady-state plasma concentration Day 14 Steady-state plasma concentration of antibiotics used
Pharmacokinetic parameters Day 14 Volume of distribution, clearance, elimination constant of antibiotics used
Trial Locations
- Locations (17)
Hospital Universitario de Cruces
🇪🇸Barakaldo, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Hospital Clínico de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitario de Donostia
🇪🇸Donostia, Spain
Hospital Universitario de Canarias
🇪🇸La Laguna, Spain
Hospital San Pedro
🇪🇸Logroño, Spain
Hospital Universitario Puerta del Hierro
🇪🇸Madrid, Spain
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Universitari MútuaTerrassa
🇪🇸Terrassa, Spain
Hospital Universitario de Álava
🇪🇸Alava, Spain
Hospital Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Málaga, Spain
Hospital Universitario Regional de Málaga
🇪🇸Málaga, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain