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RECRUITING
NCT06323668
NA

Cardiac Implantable Electronic Device RemOval Versus Full CoUrse Medical Treatment

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

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

PROCEDURE

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