Accelerated Treatment of Endocarditis (POET II)

Herlev Hospital

Status and phase: Enrolling; Phase 4

Conditions: Endocarditis

Treatments: Other: Accelerated antibiotic treatment; Other: Standard treatment length

Study type: Interventional

Funder types: Other

Identifiers

NCT05144399

H-18028566

Details and patient eligibility

About

Existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks one or more 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 financial burden on the health systems. Current guidelines fail to use available clinical and paraclinical, 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 individual 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 475 patients, approx. 125 patients with each type of bacteria (Streptococci; Enterococcus faecalis; Staphylococcus aureus).

Enrollment: 475 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admitted with left-sided infectious endocarditis (duke criteria)
• < 14 days of relevant antibiotic treatment for endocarditis
• One of the following bacteria: Streptococci, enterococcus faecalis, staphylococcus aureus
• > 18 years old

Exclusion criteria

• Known immune incompetency,
• Relapse endocarditis with 6 months,
• Unable to give informed concent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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475 participants in 2 patient groups

Accelerated antibiotic treatment

Experimental group

Description:

Patients are treated shorter than usual

Treatment:

Other: Accelerated antibiotic treatment

Standard length of antibiotic treatment

Other group

Description:

Patients are receiving the standard length of antibiotic treatment

Treatment:

Other: Standard treatment length