Overview
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.
Description
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:
- Bacteremia (excluding all enterobacterales)
- Death
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;
- Bacteremia (excluding all enterobacterales)
- Acute kidney failure
- Death
- Length of hospital stay
- Days-out-of-hospital from TAVI to 6 months
Eligibility
Inclusion Criteria:
- All patients \> 18 years of age undergoing TAVI at sites in Denmark
Exclusion Criteria:
- Patients who do not want to participate and have chosen to "opt-out" of the trial
