Existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks with one or two 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 burden on health systems. Current guidelines fail to use available 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 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 750 patients, approx. 200 patients with each type of bacteria (Streptococci; Enterococcus faecalis; Staphylococcus aureus). Interim analysis will be conducted when 150 patients have been included, to assess the frequency of the event rate and inclusion rate in order to adjust the intended size of the study population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
750
For the three main bacteria species we shorten the duration of antibiotic treatment
Usual guideline therapy
Skejby Sygehus
Aarhus, Denmark
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGGentofte Hospital
Copenhagen, Denmark
RECRUITINGHerlev Hoslpital
Copenhagen, Denmark
RECRUITINGHillerød Hospital
Hillerød, Denmark
RECRUITINGOdense Sygehus
Odense, Denmark
RECRUITINGRoskilde Sygehus
Roskilde, Denmark
RECRUITINGPrimary composite endpoint
Number of patients with at least one of the following: Death (yes/no); Embolisms (yes/no); Bacteraemia with the same microorganism (yes/no), surgery not planned at randomization (yes/no).
Time frame: 6 monts after randomization
Quality of life
Quality of life assessed by completing short version 36 (SF 36) version 2
Time frame: 6 monts after randomization and after
Expenses
Expenses associated with hospitalization and treatment of the disease. I.E., expenses to admission, examinations and medicine
Time frame: 6 monts after randomization
Duration of hospitalization
Duration of hospitalization
Time frame: 6 monts after randomization
Death
Number of patients that die
Time frame: 6 monts after randomization
Embolisms
Number of patients that have an embolism
Time frame: 6 monts after randomization
Bacteraemia with the same microorganism,
Number of patients that have Bacteraemia with the same microorganism
Time frame: 6 monts after randomization
Surgery not planned at randomization
Number of patients that have Surgery not planned at randomization
Time frame: 6 monts after randomization
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