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.
All patients > 18 years of age undergoing TAVI at sites in Denmark
Patients who do not want to participate and have chosen to "opt-out" of the trial
Crossover
Beta-lactam antibiotic with spectrum for Enterococcus faecalis
DrugBeta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) add-on in combination with cephalosporin as per-procedural prophylaxis in TAVI
Cephalosporin
DrugCephalosporin treatment
Number of patients with a composite outcome of bacteremia or death by 6 months.
Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI. Death is defined as being registered as deceased in the Danish Civil Registration System at 6 months post-TAVI.
Number of patients who died by 6 months
Death is defined as being registered as deceased in the Danish Civil Registration System 6 months post-TAVI.
Bacteremia assessed by collection of blood cultures.
Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI.
Number of patients with acute kidney failure assessed by plasma creatinine levels.
Acute kidney failure is defined as ≥50% increase in the plasma creatinine within 6 months post-TAVI and information on plasma creatinine levels is obtained from the national blood sample data.
Length of hospital stay
Length of hospital stay in relation to the TAVI-procedure
Click on the lead sponsor to view all of their trials.
