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Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment
Sponsor: Rigshospitalet, Denmark
Summary
The CIEDOUT study is an open label randomized trial in patients with possible cardiac implantable electronic device (CIED) infection. The hypothesis is that CIED removal + guideline antibiotic therapy is better than 6-weeks antibiotic therapy alone in preventing death or relapse of bacteremia in patients with bacteremia and possible CIED infection (not definite CIED infection). The objective of this study is to test whether CIED removal + guideline antibiotic therapy is superior to 6-weeks antibiotic therapy alone in prevention of the composite endpoint of death or relapse bacteremia after 6 months of follow-up in patients with CIED and systemic infection but without definite CIED infection.
Official title: Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment - the CIEDOUT Study - a Randomized Clinical Trial
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2024-05-17
Completion Date
2038-01-31
Last Updated
2024-11-20
Healthy Volunteers
No
Interventions
Cardiac implantable electronic device extraction
The CIED removal will be done as soon as possible within 7 days.
Locations (1)
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark