Accelerated Treatment of Endocarditis
ConditionEndocarditis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHerlev Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known immune incompetency,
Relapse endocarditis with 6 months,
Unable to give informed concent
Trial design
Design model
Parallel
Treatments tested in this trial
Accelerated antibiotic treatment
Other interventionE. faecalis uncomplicated: 4 weeks. E. faecalis complicated: 4 weeks. S. aureus uncomplicated: 2 weeks. S. aureus complicated: 4 weeks. Streptococci spp. NVE: 2 weeks. Streptococci spp. PVE or abscess: 3 weeks. Subsequent to cardiac surgery with a negative valve culture (organism NOT grown in laboratory from valve): Minimum 1 week after surgery regardless of previous antibiotic treatment received. Subsequent to cardiac surgery with a positive valve culture (organism grown in laboratory from valve): treatment will continue with the start date of antibiotics changed to the date of surgery. Complicated IE defined as patients with abscess, embolic event, surgically treated IE, and/or PVE. NVE: native valve endocarditis, PVE: prosthetic valve endocarditis.
Standard treatment length
Other interventionE. faecalis uncomplicated: 6 weeks. E. faecalis complicated: 6 weeks. S. aureus uncomplicated: 4 weeks. S. aureus complicated: 6 weeks. Streptococci spp. NVE: 4 weeks. Streptococci spp. PVE or abscess: 6 weeks. Subsequent to cardiac surgery with a negative valve culture (organism NOT grown in laboratory from valve): Minimum 2 weeks after surgery regardless of previous antibiotic treatment received. Subsequent to cardiac surgery with a positive valve culture (organism grown in laboratory from valve): treatment will continue with the start date of antibiotics changed to the date of surgery. Complicated IE defined as patients with abscess, embolic event, surgically treated IE, and/or PVE. NVE: native valve endocarditis, PVE: prosthetic valve endocarditis.
Treatment groups
475 Participants
are divided into 2 treatment groupsGroup A: Accelerated antibiotic treatmentExperimental treatment 1 intervention
Group B: Standard length of antibiotic treatmentOther 1 intervention
Trial outcomes
Primary outcomes
1
Combined safety endpoint of: All cause mortality, embolic episodes, not planned Heart surgery
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.
Time frame
6 months after randomization2
Primary efficacy endpoint: Difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups
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.
Time frame
6 months after randomizationSecondary outcomes
1
Expenses associated with admission and treatment
Combined endpoint consisting of expenses due to i admission ii medication iii transportation iv surgery v imaging vi home care
Time frame
6 months after randomization2
Duration of admission
Duration of admission
Time frame
6 months after randomization3
Duration of antibiotic treatment
Duration of antibiotic treatment
Time frame
6 months after randomization4
Frequency of catheter complication
Frequency of catheter complication
Time frame
6 months after randomizationSponsors and contacts
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Source ClinicalTrials.gov