NCT05398679 Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective Endocarditis
| NCT ID | NCT05398679 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fundacion Clinic per a la Recerca Biomédica |
| Condition | Endocarditis Infective |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2022-08-17 |
| Primary Completion | 2026-12-30 |
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 360 participants in total. It began in 2022-08-17 with a primary completion date of 2026-12-30.
⚠ 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
Non-inferiority trial to determine whether partial oral treatment is non-inferior to OPAT(Outpatient parenteral therapy) in patients diagnosed with infective endocarditis
Eligibility Criteria
Inclusion Criteria: * Left-sided native or prosthetic infective endocarditis based on the modified Duke criteria infected with one of the following nonresistant microorganisms: Non-resistant streptococci and other gram positive cocci,e.g., Granulicatella and Abiotrophia; Enterococcus faecalis; Staphylococcus aureus;coagulase-negative staphylococci and HACEK group. * Male or female 18 years old or older. * 10 days or more of appropriate parenteral antibiotic treatment overall and at least one week of appropriate parenteral treatment after value surgery. * Temperature inferior to 38ºC for more than two days. 5. C-reactive protein dropped to \<25% of peak value or \<20 mg/l, and white blood cell count \<15x10\^9/l during antibiotic treatment * Transthoracic / transesophageal echocardiography performed within 48 hours of randomization Exclusion Criteria: * Body mass index \>40 * Concomitant infection requiring intravenous antibiotic therapy * Inability to give informed consent to participation * Suspicion of reduced absorption of oral treatment due to abdominal disorder * Microorganisms with no oral combinations for treatment (two active antibiotics of different families) * Any immunosuppressive disease or any medical condition at the discretion of the investigator that may preclude oral or OPAT therapy * No family or appropriate home support * Reduced compliance * Women of childbearing potential with a positive pregnancy test, or participants (male or female) who wish to plan a pregnancy during the trial period * Women in lactancy period
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05398679 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 NCT05398679 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 NCT05398679 currently recruiting?
Yes, NCT05398679 is actively recruiting participants. Contact the research team at acruceta@clinic.cat for enrollment information.
Where is the NCT05398679 trial being conducted?
This trial is being conducted at Alicante, Spain, Seville, Spain, Seville, Spain, Palma de Mallorca, Spain and 11 additional locations.
Who is sponsoring the NCT05398679 clinical trial?
NCT05398679 is sponsored by Fundacion Clinic per a la Recerca Biomédica. The trial plans to enroll 360 participants.