Study Results
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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RECRUITING
PHASE4
475 participants
INTERVENTIONAL
2019-04-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Accelerated antibiotic treatment
Patients are treated shorter than usual
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 length of antibiotic treatment
Patients are receiving the standard length of antibiotic treatment
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* \< 14 days of relevant antibiotic treatment for endocarditis
* One of the following bacteria: Streptococci, enterococcus faecalis, staphylococcus aureus
* \> 18 years old
Exclusion Criteria
* Relapse endocarditis with 6 months,
* Unable to give informed concent
18 Years
ALL
No
Sponsors
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Herlev Hospital
OTHER
Responsible Party
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Kasper Iversen
Associate professor
Locations
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Rigshositalet
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Countries
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Facility Contacts
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Other Identifiers
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H-18028566
Identifier Type: -
Identifier Source: org_study_id
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