Clinical trial NCT03851575: Accelerated Treatment of Endocarditis
Official title: Accelerated Treatment of Endocarditis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infectious Endocarditis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Nordsjaellands Hospital
name: Zealand University Hospital
name: Odense University Hospital
name: Aarhus University Hospital
name: Lund University Hospital
First posted: 2019-02-22
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Patients hospitalized and diagnosed with bacterial, left-sided endocarditis as determined by the department clinician responsible based on the revised Duke criteria.
2. The patient may be included \<14 days after beginning of relevant antibiotic treatment.
3. Left-sided endocarditis with one of the following microorganisms: Streptococci; Enterococcus faecalis; Staphylococcus aureus.
4. Patients ≥ 18 years.

Exclusion Criteria:

1. Known / suspected immunocompetence (HIV, chemotherapy, prednisolone treatment (\> 20 mg / day)).
2. Incapability to give informed consent for participation.
3. Relapse Endocarditis (Endocarditis with the same bacteria within six months).

Primary outcomes:
measure: Primary composite endpoint
timeFrame: 6 monts after randomization
Secondary outcomes:
measure: Quality of life
timeFrame: 6 monts after randomization and after
measure: Expenses
timeFrame: 6 monts after randomization
measure: Duration of hospitalization
timeFrame: 6 monts after randomization
measure: Death
timeFrame: 6 monts after randomization
measure: Embolisms
timeFrame: 6 monts after randomization
measure: Bacteraemia with the same microorganism,
timeFrame: 6 monts after randomization
measure: Surgery not planned at randomization
timeFrame: 6 monts after randomization
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Skejby Sygehus
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Copenhagen
country: Denmark
facility: Gentofte Hospital
city: Copenhagen
country: Denmark
facility: Herlev Hoslpital
city: Hillerød
country: Denmark
facility: Hillerød Hospital
city: Odense
country: Denmark
facility: Odense Sygehus
city: Roskilde
country: Denmark
facility: Roskilde Sygehus
Study officials:
affiliation: Rigshospitalet, Denmark
name: Henning Bundgaard, MD
role: STUDY_CHAIR
References: