NCT05144399 Accelerated Treatment of Endocarditis
| NCT ID | NCT05144399 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Herlev Hospital |
| Condition | Endocarditis |
| Study Type | INTERVENTIONAL |
| Enrollment | 475 participants |
| Start Date | 2019-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 475 participants in total. It began in 2019-04-01 with a primary completion date of 2026-12-31.
⚠ 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
Existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks one or more types of intravenously administered antibiotics. The long hospitalization increases several risks for the patient, including mental strain and increased loss of function. Furthermore, it poses a significant financial burden on the health systems. Current guidelines fail to use available clinical and paraclinical, data collected from patients (echo, temperature, CRP, leukocytes, procalcitonin etc.) to determine duration of treatment. A strategy including these data in treatment algorithms ensures an individualized treatment, targeting the individual patient's course and response to treatment. Thus, the purpose of this open-label, prospective, non-inferiority, RCT study is to investigate the safety and effectiveness of shortening treatment of endocarditis based on the individual patient's initial treatment response, sampling 475 patients, approx. 125 patients with each type of bacteria (Streptococci; Enterococcus faecalis; Staphylococcus aureus).
Eligibility Criteria
Inclusion Criteria: * Admitted with left-sided infectious endocarditis (duke criteria) * \< 14 days of relevant antibiotic treatment for endocarditis * One of the following bacteria: Streptococci, enterococcus faecalis, staphylococcus aureus * \> 18 years old Exclusion Criteria: * Known immune incompetency, * Relapse endocarditis with 6 months, * Unable to give informed concent
Frequently Asked Questions
Who can join the NCT05144399 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Endocarditis. 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 NCT05144399 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 NCT05144399 currently recruiting?
Yes, NCT05144399 is actively recruiting participants. Visit ClinicalTrials.gov or contact Herlev Hospital to inquire about joining.
Where is the NCT05144399 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Herlev, Denmark.
Who is sponsoring the NCT05144399 clinical trial?
NCT05144399 is sponsored by Herlev Hospital. The trial plans to enroll 475 participants.