Accelerated Treatment of Endocarditis
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Herlev Hospital
- Enrollment
- 475
- Locations
- 2
- Primary Endpoint
- Combined safety endpoint of: All cause mortality, embolic episodes, not planned Heart surgery
Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Combined safety endpoint of: All cause mortality, embolic episodes, not planned Heart surgery
Time Frame: 6 months after randomization
The primary endpoint is a combined endpoint consisting of the following events occurring within six months after the earliest time of potential treatment discontinuation: Death; Embolisms; Heart surgery not planned at the time of randomization.
Primary efficacy endpoint: Difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups
Time Frame: 6 months after randomization
The primary efficacy endpoint is the difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups, assessed from and until 6 months after randomization.
Secondary Outcomes
- Duration of admission(6 months after randomization)
- Duration of antibiotic treatment(6 months after randomization)
- Frequency of catheter complication(6 months after randomization)
- Unplanned Heart surgery(6 months after randomization)
- Expenses associated with admission and treatment(6 months after randomization)
- Embolic events(6 months after randomization)
- Re-bacteremia with the primary pathogen(6 months after randomization)
- All cause mortality(6 months after randomization)
Investigators
Kasper Iversen
Associate professor
Herlev Hospital