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The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
Sponsor: Copenhagen University Hospital, Rigshospitalet
Summary
The study is a prospective, crossover, cluster randomized trial in patients undergoing transcatheter aortic valve implantation (TAVI). The study tests whether cephalosporin plus beta-lactam antibiotic with spectrum for Enterococcus faecalis as per procedural prophylaxis is superior to cephalosporin alone in reducing the composite outcome of bacteremia or death at 6 months post-TAVI.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1986
Start Date
2026-10-01
Completion Date
2030-03-31
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Interventions
Beta-lactam antibiotic with spectrum for Enterococcus faecalis
Beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) add-on in combination with cephalosporin as per-procedural prophylaxis in TAVI
Cephalosporin
Cephalosporin treatment
Locations (5)
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Skåne University Hospital Lund
Lund, Sweden