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

N/ANot Yet RecruitingNCT07442357

Rigshospitalet, Denmark1,986 enrolled

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,986

Conditions

Aortic Valve Stenosis

Interventions

Beta-lactam antibiotic with spectrum for Enterococcus faecalisDRUG

Beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) add-on in combination with cephalosporin as per-procedural prophylaxis in TAVI

CephalosporinDRUG

Cephalosporin treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Outcomes

Primary Outcomes

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.