Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.
NCT ID: NCT06423898
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
284 participants
INTERVENTIONAL
2024-10-09
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Continuous intravenous antibiotic infusion
Ampicillin 12g/24h plus ceftriaxone 4g/12h continuous infusion. The duration of treatment will be 42 days.
Ampicillin plus ceftriaxone in continuous infusion
Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis
Standard treatment
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
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, amoxicillin plus rifampin, linezolid plus moxifloxacin or linezolid plus rifampin.
Interventions
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Ampicillin plus ceftriaxone in continuous infusion
Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis
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, amoxicillin plus rifampin, linezolid plus moxifloxacin or linezolid plus rifampin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Possible or definitive diagnosis of infective endocarditis due to Enterococcus faecalis
* Signed informed consent of patients
Exclusion Criteria
* Pregnancy and lactation
* Polymicrobial infection including microorganisms different to E. faecalis
18 Years
ALL
No
Sponsors
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Spanish Clinical Research Network - SCReN
NETWORK
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
OTHER
Responsible Party
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Principal Investigators
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HUVR Cesar Arístides de Alarcón González, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Fundación para la Gestión de la Investigación en Salud de Sevilla
Locations
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Hospital Universitario de Álava
Alava, , Spain
Hospital Universitario de Cruces
Barakaldo, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clínico de Barcelona
Barcelona, , Spain
Hospital Universitario de Donostia
Donostia / San Sebastian, , Spain
Hospital Universitario Virgen de las Nieves
Granada, , Spain
Hospital San Pedro
Logroño, , Spain
Hospital Universitario Gregorio Marañón
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Puerta del Hierro
Madrid, , Spain
Hospital Universitario Regional de Málaga
Málaga, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, , Spain
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Universitari MútuaTerrassa
Terrassa, , Spain
Countries
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Central Contacts
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Facility Contacts
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MD
Role: backup
Other Identifiers
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DOBLEI
Identifier Type: -
Identifier Source: org_study_id
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