Continuous versus standard intermittent ampicillin plus ceftriaxone for Enterococcus faecalis endocarditis
Efficacy and Safety of Ampicillin and Ceftriaxone Continuous Infusion Versus Standard Therapy for the Treatment of Enterococcus Faecalis Infective Endocarditis (DOβLEI Study)
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 |
| Enrollment | 284 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla Academic / other |
| Locations | 18 sites (Alava and 17 other locations) |
| Trial ID | NCT06423898 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Alava and 17 other locations
- Hospital Universitario de Álava — Alava, Spain (Recruiting)
- Hospital Universitario de Cruces — Barakaldo, Spain (Active_not_recruiting)
- Hospital Universitario Vall d'Hebron — Barcelona, Spain (Not_yet_recruiting)
- 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 de Canarias — San Cristóbal de La Laguna, Spain (Recruiting)
- Hospital Universitario Marqués de Valdecilla — Santander, Spain (Recruiting)
- Hospital Universitario Virgen Macarena — Seville, Spain (Active_not_recruiting)
- Hospital Universitario Virgen del Rocío — Seville, Spain (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.