Antibiotic Prophylaxis for TAVI: Is Adding a beta-lactam effective?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PAPPI trial is a prospective, cluster-randomized, crossover study conducted across Danish TAVI centers to compare two antibiotic prophylaxis strategies given as a single pre-procedural dose. One group receives cephalosporin alone, while the other receives cephalosporin plus a beta-lactam antibiotic targeting Enterococcus faecalis. The primary outcome is a composite of bacteremia (excluding Enterobacterales) or death within six months after the TAVI procedure; secondary analyses consider each component separately and other clinical outcomes. All patients undergoing TAVI at participating centers are eligible, with follow-up through six months post-procedure. The study is unblinded and includes all Danish centers performing TAVI, with results used to guide prophylaxis recommendations.

Why it matters

Who can join: the full rules

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

Where it's running

• Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Copenhagen University Hospital, Rigshospitalet
  Copenhagen, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting
• Skåne University Hospital Lund
  Lund, Sweden Not yet recruiting

Study contacts

• Study coordinator: Emil L Fosbøl, MD, PhD
• Email: emil.fosboel@regionh.dk
• Phone: + 45 35 45 63 40

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• How the type of sedation affects recovery after TAVR

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.