Aortic Valve StenosisPAPPINCT07442357
The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
A study testing Beta-lactam antibiotic with spectrum for Enterococcus faecalis and Cephalosporin in people with Aortic Valve Stenosis, run by Copenhagen University Hospital, Rigshospitalet at 5 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Beta-lactam antibiotic with spectrum for Enterococcus faecalis and Cephalosporin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,986 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Oct 2026to 31 Mar 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients > 18 years of age undergoing TAVI at sites in Denmark
Who cannot join
- Patients who do not want to participate and have chosen to "opt-out" of the trial
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Denmark4 sites, 4 recruiting
- Recruiting
Aalborg University Hospital
Aalborg
Ashkan Eftekhari, +45 20 74 88 25, asef@rn.dk
- Recruiting
Aarhus University Hospital
Aarhus
Jonas Agerlund Povlsen, +45 4013 8742, jonapovl@rm.dk
- Recruiting
Copenhagen University Hospital, Rigshospitalet
Copenhagen
Emil L Fosbøl, +4535456340, emil.fosboel@regionh.dk
- Recruiting
Odense University Hospital
Odense
Marlene Tofterup, +45 29240987, Marlene.Tofterup@rsyd.dk
Sweden1 site, 1 recruiting
- Not yet recruiting
Skåne University Hospital Lund
Lund
Sasha Koul, +46 46 17 10 00, sasha.koul@med.lu.se
About this study
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.
Read the 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
- Conditions
- Aortic Valve Stenosis
- Being tested
- Beta-lactam antibiotic with spectrum for Enterococcus faecalis, Cephalosporin
- Keywords
- Aortic Valve Stenosis, Aortic Valve Replacement, Transcatheter Aortic Valve Replacement, Aortic Valve, Cephalosporin, Ampicllin, Bacteremia, Per Procedure Prophylaxis
- Medical subject headings
- Aortic Valve Stenosis, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis | Active comparator | Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis Receives: Drug: Beta-lactam antibiotic with spectrum for Enterococcus faecalis; Drug: Cephalosporin |
| Cephalosporin (1st, 2nd, 3rd generation) | Active comparator | Cephalosporin (1st, 2nd, 3rd generation) Receives: Drug: Cephalosporin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months post-TAVI
Secondary outcomes (5)
Number of patients who died by 6 months
Death is defined as being registered as deceased in the Danish Civil Registration System 6 months post-TAVI.
Measured: 6 months post-TAVI
Bacteremia assessed by collection of blood cultures.
Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI.
Measured: 6 months post-TAVI
Number of patients with acute kidney failure assessed by plasma creatinine levels.
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.
Measured: 6 months post-TAVI
Length of hospital stay
Length of hospital stay in relation to the TAVI-procedure
Measured: 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
Days-out-of-hospital from TAVI to 6 months
Measured: 6 months post-TAVI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Oct 2026
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, crossover, cluster-randomized study
- Masking
- None (open label)
- Enrolment
- 1,986 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emil Loldrup Fosbol, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442357
- Sponsor's protocol ID
- p-2025-19665
- Acronym
- PAPPI
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No