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NCT Number: NCT07442357

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Bacteremia Bacterial Infections Bacterial Infections and Mycoses Cardiovascular Diseases Heart Diseases Heart Valve Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beta-lactam antibiotic with spectrum for Enterococcus faecalis

Drug

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

cephalosporin

Drug

Cephalosporin treatment

Primary outcomes

  1. Number of patients with a composite outcome of bacteremia or death by 6 months.

    Time frame: 6 months post-TAVI

    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.

Secondary outcomes

  1. Number of patients who died by 6 months

    Time frame: 6 months post-TAVI

    Death is defined as being registered as deceased in the Danish Civil Registration System 6 months post-TAVI.

  2. Bacteremia assessed by collection of blood cultures.

    Time frame: 6 months post-TAVI

    Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI.

  3. Number of patients with acute kidney failure assessed by plasma creatinine levels.

    Time frame: 6 months post-TAVI

    Acute kidney failure is defined as ≥50% increase in the plasma creatinine within 6 months post-TAVI and information on plasma creatinine levels is obtained from the national blood sample data.

  4. 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.

    Length of hospital stay in relation to the TAVI-procedure

  5. Days-out-of-hospital from TAVI to 6 months

    Time frame: 6 months post-TAVI

    Days-out-of-hospital from TAVI to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Emil L Fosbøl, MD, PhD

CONTACT

[email protected]

+ 45 35 45 63 40

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Acronym: PAPPI

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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