The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Beta-lactam antibiotic with spectrum for Enterococcus faecalis, Cephalosporin.
- Who it may be relevant to
- Registry conditions: Aortic Valve Stenosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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
Interventions
- 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
Primary outcome measures
- Number of patients with a composite outcome of bacteremia or death by 6 months. [Time frame: 6 months post-TAVI]
Secondary outcome measures (5)
- Number of patients who died by 6 months [Time frame: 6 months post-TAVI]
- Bacteremia assessed by collection of blood cultures. [Time frame: 6 months post-TAVI]
- Number of patients with acute kidney failure assessed by plasma creatinine levels. [Time frame: 6 months post-TAVI]
- Length of hospital stay [Time frame: From the day of TAVI-procedure until the day of discharge after the TAVI-procedure e.g. days from TAVI-procedure until discharge assessed up to 6 months post-TAVI due to end of follow-up.]
- Days-out-of-hospital from TAVI to 6 months [Time frame: 6 months post-TAVI]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Denmark · 1 center
- Copenhagen University Hospital, Rigshospitalet — Copenhagen
Identifiers
NCT: NCT07442357 · p-2025-19665