Accelerated Treatment of Endocarditis

NCT ID: NCT05144399

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

475 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Endocarditis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Accelerated antibiotic treatment

Patients are treated shorter than usual

Group Type EXPERIMENTAL

Accelerated antibiotic treatment

Intervention Type 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.

Standard length of antibiotic treatment

Patients are receiving the standard length of antibiotic treatment

Group Type OTHER

Standard treatment length

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kasper Iversen

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rigshositalet

Copenhagen, , Denmark

Site Status RECRUITING

Herlev Hospital

Herlev, , Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Henning Bundgaard

Role: primary

+4535450512

kasper iversen

Role: primary

+4538686009

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H-18028566

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Bacterial Vaginosis
NCT00324818 COMPLETED PHASE4