NCT07442357

The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,986 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DRUG	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
DRUG	Cephalosporin	Cephalosporin treatment

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2026-03-02
• Last updated: 2026-03-02

Locations

1 site across 1 country: Denmark