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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.
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:
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Cephalosporin (1st, 2nd, 3rd generation) | Active Comparator | Cephalosporin (1st, 2nd, 3rd generation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-TAVI |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-TAVI |
| Bacteremia assessed by collection of blood cultures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emil L Fosbøl, MD, PhD | Contact | + 45 35 45 63 40 | emil.fosboel@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Rigshospitalet | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D016470 | Bacteremia |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008997 | Monobactams |
| D002511 | Cephalosporins |
| ID | Term |
|---|---|
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 |
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Prospective, crossover, cluster-randomized study
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| Cephalosporin | Drug | Cephalosporin treatment |
|
Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI.
| 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. | 6 months post-TAVI |
| Length of hospital stay | Length of hospital stay in relation to the TAVI-procedure | 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 | 6 months post-TAVI |
| D014694 |
| Ventricular Outflow Obstruction |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013843 | Thiazines |