Accelerated Treatment of Endocarditis

NCT05144399 | Recruiting Phase 4 DMC

• 1 other identifier: H-18028566
• Study Type: interventional
• Target: 475
• Locations: 1 country
• Sites: 2

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).

Conditions

Endocarditis

Outcome Measures

Primary Outcomes (2)

• 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 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 Outcomes (8)

• Expenses associated with admission and treatment

  6 months after randomization

• Duration of admission

  6 months after randomization

• Duration of antibiotic treatment

  6 months after randomization

• Frequency of catheter complication

  6 months after randomization

• Unplanned Heart surgery

  6 months after randomization

Study Arms (2)

Accelerated antibiotic treatment

EXPERIMENTAL

Patients are treated shorter than usual

Other: Accelerated antibiotic treatment

Standard length of antibiotic treatment

OTHER

Patients are receiving the standard length of antibiotic treatment

Other: Standard treatment length

Interventions

Accelerated antibiotic treatment OTHER

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.

Accelerated antibiotic treatment

Standard treatment length OTHER

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.

Standard length of antibiotic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (2)

Rigshositalet

Copenhagen, 2100, Denmark

RECRUITING

Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: December 3, 2021
• Study Start: April 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)