Accelerated Treatment of Endocarditis

NCT ID: NCT03851575

Last Updated: 2020-02-06

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2023-12-10

Brief Summary

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Existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks with one or two 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 burden on health systems. Current guidelines fail to use available 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 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 750 patients, approx. 200 patients with each type of bacteria (Streptococci; Enterococcus faecalis; Staphylococcus aureus). Interim analysis will be conducted when 150 patients have been included, to assess the frequency of the event rate and inclusion rate in order to adjust the intended size of the study population.

Detailed Description

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Conditions

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Infectious Endocarditis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control arm

Usual guideline therapy

Group Type ACTIVE_COMPARATOR

Usual guideline therapy

Intervention Type OTHER

Usual guideline therapy

Accelerated arm

Accelerated treatment of endocarditis

Group Type EXPERIMENTAL

Accelerated treatment of endocarditis

Intervention Type OTHER

For the three main bacteria species we shorten the duration of antibiotic treatment

Interventions

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Accelerated treatment of endocarditis

For the three main bacteria species we shorten the duration of antibiotic treatment

Intervention Type OTHER

Usual guideline therapy

Usual guideline therapy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients hospitalized and diagnosed with bacterial, left-sided endocarditis as determined by the department clinician responsible based on the revised Duke criteria.
2. The patient may be included \<14 days after beginning of relevant antibiotic treatment.
3. Left-sided endocarditis with one of the following microorganisms: Streptococci; Enterococcus faecalis; Staphylococcus aureus.
4. Patients ≥ 18 years.

Exclusion Criteria

1. Known / suspected immunocompetence (HIV, chemotherapy, prednisolone treatment (\> 20 mg / day)).
2. Incapability to give informed consent for participation.
3. Relapse Endocarditis (Endocarditis with the same bacteria within six months).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role collaborator

Aarhus University Hospital

OTHER

Sponsor Role collaborator

Lund University Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Kasper Iversen

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Henning Bundgaard, MD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

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Skejby Sygehus

Aarhus, , Denmark

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Gentofte Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Herlev Hoslpital

Copenhagen, , Denmark

Site Status RECRUITING

Hillerød Hospital

Hillerød, , Denmark

Site Status RECRUITING

Odense Sygehus

Odense, , Denmark

Site Status RECRUITING

Roskilde Sygehus

Roskilde, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Kasper K Iversen, MD

Role: CONTACT

+4528712753

Facility Contacts

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Henrik Wiggers, MD

Role: primary

Henning Bundgaard

Role: primary

Niels Bruun, MD

Role: primary

Kasper Iversen

Role: primary

Niels Tønder

Role: primary

Sabine Gill, MD

Role: primary

Hanne Elming

Role: primary

Other Identifiers

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H-18028566

Identifier Type: -

Identifier Source: org_study_id

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