NCT03851575

Accelerated Treatment of Endocarditis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-01-17
• Primary completion: 2023-06-10
• Completion: 2023-12-10
• First posted: 2019-02-22
• Last updated: 2020-02-06

Locations

7 sites across 1 country: Denmark