NCT06423898 Ampicillin and Ceftriaxone for the Treatment of Enterococcus Faecalis Infective Endocarditis.
| NCT ID | NCT06423898 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
| Condition | Endocarditis, Infective |
| Study Type | INTERVENTIONAL |
| Enrollment | 284 participants |
| Start Date | 2024-10-09 |
| Primary Completion | 2027-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 284 participants in total. It began in 2024-10-09 with a primary completion date of 2027-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 treatment, usually administered in hospitalized patients.
Eligibility 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
Contact & Investigator
HUVR Cesar Arístides de Alarcón González, MD-PhD
PRINCIPAL INVESTIGATOR
Fundación para la Gestión de la Investigación en Salud de Sevilla
Frequently Asked Questions
Who can join the NCT06423898 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Endocarditis, Infective. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06423898 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06423898 currently recruiting?
Yes, NCT06423898 is actively recruiting participants. Contact the research team at lauraherrerahidalgo@gmail.com for enrollment information.
Where is the NCT06423898 trial being conducted?
This trial is being conducted at Alava, Spain, Barakaldo, Spain, Barcelona, Spain, Barcelona, Spain and 11 additional locations.
Who is sponsoring the NCT06423898 clinical trial?
NCT06423898 is sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. The principal investigator is HUVR Cesar Arístides de Alarcón González, MD-PhD at Fundación para la Gestión de la Investigación en Salud de Sevilla. The trial plans to enroll 284 participants.