The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
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.
The PAPPI trial is designed as a prospective, crossover, unblinded, cluster randomized trial. The study includes all TAVI centers in Denmark. Each center will be included for either single dose cephalosporin (1st, 2nd or 3rd generation) plus a beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) or single dose of a cephalosporin (1st, 2nd or 3rd generation) as antibiotic prophylaxis in relation to TAVI. The antibiotic(s) will be given as a single dose intravenously per-procedural. Patients will be followed from date of TAVI procedure until 6 months post procedure.
The primary outcome of the PAPPI trial will be a composite of the following components within 6 months post TAVI:
Secondary outcomes will be each separate component of the primary outcome and will be ana-lyzed separately as time-to-first event analysis. Additional secondary outcomes will be;
Inclusion Criteria:
Exclusion Criteria:
emil.fosboel@regionh.dk+ 45 35 45 63 40