Continuous versus standard intermittent ampicillin plus ceftriaxone for Enterococcus faecalis endocarditis
Official title: Efficacy and Safety of Ampicillin and Ceftriaxone Continuous Infusion Versus Standard Therapy for the Treatment of Enterococcus Faecalis Infective Endocarditis (DOβLEI Study)
Run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · NCT06423898 · Data updated 2026-11-12
This study will see if giving ampicillin plus ceftriaxone as a continuous infusion works as well and is as safe as the usual intermittent dosing for adults with Enterococcus faecalis infective endocarditis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 284 (estimated) |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Academic / other |
| Locations | 18 sites (Alava and 17 other locations) |
| Status | Recruiting |
| Started | October 9, 2024 |
| Main results expected | July 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT06423898 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a possible or definite diagnosis of Enterococcus faecalis infective endocarditis who can give informed consent and do not have allergy to penicillins/cephalosporins, pregnancy/lactation, or polymicrobial infection.
✕Probably not a fit
Patients with penicillin or cephalosporin allergy, pregnancy or lactation, polymicrobial infections including organisms other than E. faecalis, or clinical situations requiring prolonged inpatient care are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase IV, open-label, randomized multicenter non-inferiority trial comparing continuous infusion of ampicillin plus ceftriaxone with the standard intermittent regimen for Enterococcus faecalis infective endocarditis. Adult patients with a possible or definite diagnosis are randomized to continuous infusion or standard care, with most treatment delivered in settings approximating routine outpatient care. Key outcomes include treatment success, mortality, serious adverse events, total antibiotic days, and days of hospitalization, with treatment lasting around 42 days and final follow-up at 365 days after treatment. The protocol is pragmatic, aiming to keep study visits similar to normal clinical follow-up to reflect real-world practice.
Why it matters
Potential benefit: If successful, the continuous-infusion approach could shorten hospital stays, lower hospital-related complications, and allow more treatment to be given safely as outpatient care.
How similar studies have gone: Smaller observational studies and outpatient infusion programs have suggested continuous beta-lactam infusions can be effective, but high-quality randomized non-inferiority data specific to E. faecalis endocarditis remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Hospital Universitario de Álava
Alava, Spain Recruiting -
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain Recruiting -
Hospital Universitario Marqués de Valdecilla
Santander, Spain Recruiting -
Hospital Universitario Virgen del Rocío
Seville, Spain Recruiting -
Hospital Universitario de Cruces
Barakaldo, Spain Active not recruiting -
Hospital Universitario Vall d'Hebron
Barcelona, Spain Not yet recruiting
Show 12 more locations
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Hospital Clínico de Barcelona
Barcelona, Spain Not yet recruiting -
Hospital Universitario de Donostia
Donostia / San Sebastian, Spain Active not recruiting -
Hospital Universitario Virgen de las Nieves
Granada, Spain Active not recruiting -
Hospital San Pedro
Logroño, Spain Active not recruiting -
Hospital Universitario Gregorio Marañón
Madrid, Spain Active not recruiting -
Hospital Clínico San Carlos
Madrid, Spain Not yet recruiting -
Hospital Universitario La Paz
Madrid, Spain Not yet recruiting -
Hospital Universitario Puerta del Hierro
Madrid, Spain Active not recruiting -
Hospital Universitario Regional de Málaga
Málaga, Spain Active not recruiting -
Hospital Universitario Virgen de la Victoria
Málaga, Spain Active not recruiting -
Hospital Universitario Virgen Macarena
Seville, Spain Active not recruiting -
Hospital Universitari MútuaTerrassa
Terrassa, Spain Active not recruiting
Study contacts
- Principal investigator: HUVR Cesar Arístides de Alarcón González, MD-PhD — Fundación para la Gestión de la Investigación en Salud de Sevilla
- Study coordinator: Laura Herrera Hidalgo, MD-PhD
- Email: lauraherrerahidalgo@gmail.com
- Phone: +34955013414
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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San Matteo Endocarditis Registry (STEADY)
This registry collects health and treatment information from people diagnosed with infective endocarditis at San Matteo to better understand their care and outcomes.
-
Comparing oral antibiotics to outpatient parenteral therapy for infective endocarditis
This study is testing if taking oral antibiotics at home is just as effective as getting antibiotics through an IV for patients with left-sided infective endocarditis.
-
Prognosis of Infectious Endocarditis
This study looks at how infectious endocarditis affects people with both natural and artificial heart valves to better understand the disease and improve treatment outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.