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

Study acronym: PAPPI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Mar 31, 2029 → Mar 31, 2030
See other at-risk trials from Copenhagen University Hospital, Rigshospitalet

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Mar 31, 2029 to Mar 31, 2030
  2. Recruitment opened Show 6 more changesShow less
    • Lead sponsor: Rigshospitalet, Denmark to Copenhagen University Hospital, Rigshospitalet
    • Start date: Jun 1, 2026 to Oct 1, 2026
    • Trial sites expanded: 1 → 5 locations
    • Primary and study completion moved earlier from Jun 1, 2029 to Mar 31, 2029
    • Study description expanded, about 7 words
    • Eligibility criteria expanded, about 2 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07442357
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Conditions
(from sponsor)		 Aortic Valve Stenosis
Related terms Aortic Valve Stenosis, Bacteremia
Enrollment 1,986 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov