Accelerated Treatment of Endocarditis

Endocarditis Clinical Trial

— POET II  

Official title:

Accelerated Treatment of Endocarditis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05144399
• Other study ID #: H-18028566
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Herlev Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 475
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis

Intervention

Other:
• Accelerated antibiotic treatment
E. faecalis uncomplicated: 4 weeks. E. faecalis complicated: 4 weeks. S. aureus uncomplicated: 2 weeks. S. aureus complicated: 4 weeks. Streptococci spp. NVE: 2 weeks. Streptococci spp. PVE or abscess: 3 weeks. Subsequent to cardiac surgery with a negative valve culture (organism NOT grown in laboratory from valve): Minimum 1 week after surgery regardless of previous antibiotic treatment received. Subsequent to cardiac surgery with a positive valve culture (organism grown in laboratory from valve): treatment will continue with the start date of antibiotics changed to the date of surgery. Complicated IE defined as patients with abscess, embolic event, surgically treated IE, and/or PVE. NVE: native valve endocarditis, PVE: prosthetic valve endocarditis.
• Standard treatment length
E. faecalis uncomplicated: 6 weeks. E. faecalis complicated: 6 weeks. S. aureus uncomplicated: 4 weeks. S. aureus complicated: 6 weeks. Streptococci spp. NVE: 4 weeks. Streptococci spp. PVE or abscess: 6 weeks. Subsequent to cardiac surgery with a negative valve culture (organism NOT grown in laboratory from valve): Minimum 2 weeks after surgery regardless of previous antibiotic treatment received. Subsequent to cardiac surgery with a positive valve culture (organism grown in laboratory from valve): treatment will continue with the start date of antibiotics changed to the date of surgery. Complicated IE defined as patients with abscess, embolic event, surgically treated IE, and/or PVE. NVE: native valve endocarditis, PVE: prosthetic valve endocarditis.

Locations

Country	Name	City	State
Denmark	Rigshositalet	Copenhagen
Denmark	Herlev Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined safety endpoint of: All cause mortality, embolic episodes, not planned Heart surgery	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.	6 months after randomization
Primary	Primary efficacy endpoint: Difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups	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.	6 months after randomization
Secondary	Expenses associated with admission and treatment	Combined endpoint consisting of expenses due to i admission ii medication iii transportation iv surgery v imaging vi home care	6 months after randomization
Secondary	Duration of admission	Duration of admission	6 months after randomization
Secondary	Duration of antibiotic treatment	Duration of antibiotic treatment	6 months after randomization
Secondary	Frequency of catheter complication	Frequency of catheter complication	6 months after randomization
Secondary	Unplanned Heart surgery	• 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.	6 months after randomization
Secondary	All cause mortality	All cause mortality	6 months after randomization
Secondary	Embolic events	Embolic events	6 months after randomization
Secondary	Re-bacteremia with the primary pathogen	• 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.	6 months after randomization