A Phase 4 interventional study of Ampicillin plus ceftriaxone in continuous infusion and Ampicillin plus ceftriaxone in intermittent infusion of 14 days, after which the treatment may be changed in Endocarditis, Infective, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Recruiting at 18 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-25.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Phase 4, Interventional, and Treatment
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.
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.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 284 is above the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 120 studies on the registry; 26 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ampicillin 12g/24h plus ceftriaxone 4g/12h continuous infusion. The duration of treatment will be 42 days.
Drug: Ampicillin plus ceftriaxone in continuous infusion
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
Drug: Ampicillin plus ceftriaxone in intermittent infusion of 14 days, after which the treatment may be changed
Continuous intravenous antibiotic infusion during 42 days for Infective Endocarditis
Also known as: Experimental regimen
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.
Also known as: Control regimen
Clinical failure
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
Time frame: One year after the end of the treatment
Therapeutic failure
Number of deaths
Time frame: Up to 12 months after treatment administration
Cardiac surgeries
Number of unplanned cardiac surgeries
Time frame: Up to 12 months after treatment administration
Readmissions
Number of unplanned readmissions
Time frame: Up to 12 months after treatment administration
Adverse events
Number of medication-related adverse events
Time frame: From randomisation until 30 days after the last dose administration
Antibiotic treatment days
Number of antibiotic treatment days
Time frame: Up to 12 months after treatment administration
Outpatient Parenteral Antimicrobial Therapy
Number of Outpatient Parenteral Antimicrobial Therapy
Time frame: Up to 12 months after treatment administration
Healthcare-associated infections
Number of healthcare-associated infections
Time frame: Up to 12 months after treatment administration
Recurrence
Number of recurrence of Enterococcus faecalis infective endocarditis
Time frame: Up to 12 months after treatment administration
Minimum free serum concentration
Minimum free serum concentration of antibiotics used
Time frame: Day 14
Steady-state plasma concentration
Steady-state plasma concentration of antibiotics used
Time frame: Day 14
Pharmacokinetic parameters
Volume of distribution, clearance, elimination constant of antibiotics used
Time frame: Day 14
Minimum Inhibitory Concentration
Minimum Inhibitory Concentration of ampicillin induced by ceftriaxone in the strains responsible for recurrences and control strains
Time frame: Day 14
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Plan to share: Yes — The results will be shared with the investigators involved in the study, and will be shared when the analysis of the results is performed.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: 6 months
Access criteria: Direct collaborators within the study
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Jul 2027, 33 months after the start.
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