Accelerated Treatment of Endocarditis

Phase 4

Recruiting

• Conditions: Endocarditis
• Interventions: Other: Accelerated antibiotic treatment; Other: Standard treatment length

• Registration Number: NCT05144399
• Lead Sponsor: Herlev Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-01
• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 475

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Accelerated antibiotic treatment	Accelerated antibiotic treatment	Patients are treated shorter than usual
Standard length of antibiotic treatment	Standard treatment length	Patients are receiving the standard length of antibiotic treatment

Primary Outcome Measures

Name	Time	Method
Combined safety endpoint of: All cause mortality, embolic episodes, not planned Heart surgery	6 months after randomization	The primary endpoint is a combined endpoint consisting of the following events occurring within six months after the earliest time of potential treatment discontinuation: Death; Embolisms; Heart surgery not planned at the time of randomization.
Primary efficacy endpoint: Difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups	6 months after randomization	The primary efficacy endpoint is the difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups, assessed from and until 6 months after randomization.

Secondary Outcome Measures

Name	Time	Method
Duration of admission	6 months after randomization	Duration of admission
Duration of antibiotic treatment	6 months after randomization	Duration of antibiotic treatment
Frequency of catheter complication	6 months after randomization	Frequency of catheter complication
Unplanned Heart surgery	6 months after randomization	• Unplanned cardiac valve surgery defined as any cardiac surgery which is not planned at the time of randomization. Data will be extracted from the electronic patient journal.
Expenses associated with admission and treatment	6 months after randomization	Combined endpoint consisting of expenses due to i admission ii medication iii transportation iv surgery v imaging vi home care
Embolic events	6 months after randomization	Embolic events
Re-bacteremia with the primary pathogen	6 months after randomization	• Relapse of bacteremia defined as a positive blood culture with the same microorganism as during the initial IE admission (streptococci spp., S. aureus, or E. faecalis). Data will be extracted from the electronic patient journal.
All cause mortality	6 months after randomization	All cause mortality

Trial Locations

Locations (2)

Herlev Hospital; 🇩🇰 Herlev, Denmark

Rigshositalet; 🇩🇰 Copenhagen, Denmark