Accelerated Treatment of Endocarditis

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.

Conditions

• Infectious Endocarditis

Interventions

OTHER

Accelerated treatment of endocarditis

For the three main bacteria species we shorten the duration of antibiotic treatment

OTHER

Usual guideline therapy

Usual guideline therapy

Sponsors & Collaborators

• Herlev Hospital

  collaborator OTHER

• Nordsjaellands Hospital

  collaborator OTHER

• Zealand University Hospital

  collaborator OTHER

• Odense University Hospital

  collaborator OTHER

• Aarhus University Hospital

  collaborator OTHER

• Lund University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  lead OTHER

Principal Investigators

• Henning Bundgaard, MD · Rigshospitalet, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-01-17

Primary Completion

2023-06-10

Completion

2023-12-10

Countries

• Denmark

Study Locations