Accelerated Treatment of Endocarditis

Study Overview
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Brief Summary
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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.

Official Title
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Accelerated Treatment of Endocarditis

Conditions
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Infectious Endocarditis

Intervention / Treatment
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* Other: Accelerated treatment of endocarditis
* Other: Usual guideline therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalized and diagnosed with bacterial, left-sided endocarditis as determined by the department clinician responsible based on the revised Duke criteria. The patient may be included <14 days after beginning of relevant antibiotic treatment. Left-sided endocarditis with one of the following microorganisms: Streptococci; Enterococcus faecalis; Staphylococcus aureus. Patients ≥ 18 years. Exclusion Criteria: Known / suspected immunocompetence (HIV, chemotherapy, prednisolone treatment (> 20 mg / day)). Incapability to give informed consent for participation. Relapse Endocarditis (Endocarditis with the same bacteria within six months).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control arm<br>Usual guideline therapy | Other: Usual guideline therapy<br>* Usual guideline therapy<br>|
| Experimental: Accelerated arm<br>Accelerated treatment of endocarditis | Other: Accelerated treatment of endocarditis<br>* For the three main bacteria species we shorten the duration of antibiotic treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary 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). | 6 monts after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life assessed by completing short version 36 (SF 36) version 2 | 6 monts after randomization and after | 
| Expenses | Expenses associated with hospitalization and treatment of the disease. I.E., expenses to admission, examinations and medicine | 6 monts after randomization | 
| Duration of hospitalization | Duration of hospitalization | 6 monts after randomization | 
| Death | Number of patients that die | 6 monts after randomization | 
| Embolisms | Number of patients that have an embolism | 6 monts after randomization | 
| Bacteraemia with the same microorganism, | Number of patients that have Bacteraemia with the same microorganism | 6 monts after randomization | 
| Surgery not planned at randomization | Number of patients that have Surgery not planned at randomization | 6 monts after randomization |