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Antibiotics Vs Antibiotics and Surgical ThERapy for Infective Endocarditis
Sponsor: Emil Loldrup Fosbol
Summary
Infective endocarditis (IE) is a deadly disease and the incidence is increasing. An important initial assessment of patients with IE includes whether surgical treatment is indicated; yet, appropriate data to guide this assessment do not exist. The ASTERIx study will assess whether a surgical approach in addition to medical care for treatment of IE is superior to medical care alone. In total, 496 patients will be included in the study over four years. The study is event-driven and will require at least 240 events. The study will assess the primary composite outcome of death, embolization, relapse of IE, new heart failure or reinfection. Study participants who survive to discharge will be followed by routine clinical check-ups at one- and four-weeks post-discharge and at three months. Additionally a 12-month study follow-up is planned. The investigators will also conduct a small substudy to assess the frequency of silent emboli.
Key Details
Gender
All
Age Range
18 Years - 84 Years
Study Type
INTERVENTIONAL
Enrollment
496
Start Date
2021-09-09
Completion Date
2026-06-01
Last Updated
2024-11-14
Healthy Volunteers
No
Conditions
Interventions
Heart valve surgery
Heart valve surgery will be performed as soon as possible and preferably within 48 hours
Locations (15)
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
University Hospital of Copenhagen, Rigshospitalet
Copenhagen, Denmark
Amager Hvidovre Hospital
Copenhagen, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Herlev and Gentofte Hospital
Gentofte Municipality, Denmark
Nordsjællands Hospital
Hillerød, Denmark
Odense University Hospital
Odense, Denmark
Zealand University Hospital
Roskilde, Denmark
Leipzig Heart Center
Leipzig, Germany
Amsterdam University Medical Center
Amsterdam, Netherlands
Catharina Hospital
Eindhoven, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Karolinska Institutet
Stockholm, Solna, Sweden
Linköping Heart Center, University Hospital
Linköping, Sweden