Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:26 AM
Study NCT ID:
NCT07442357
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008997', 'term': 'Monobactams'}, {'id': 'D002511', 'term': 'Cephalosporins'}], 'ancestors': [{'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013843', 'term': 'Thiazines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Prospective, crossover, cluster-randomized study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1986}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with a composite outcome of bacteremia or death by 6 months.', 'timeFrame': '6 months post-TAVI', 'description': 'Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI.\n\nDeath is defined as being registered as deceased in the Danish Civil Registration System at 6 months post-TAVI.'}], 'secondaryOutcomes': [{'measure': 'Number of patients who died by 6 months', 'timeFrame': '6 months post-TAVI', 'description': 'Death is defined as being registered as deceased in the Danish Civil Registration System 6 months post-TAVI.'}, {'measure': 'Bacteremia assessed by collection of blood cultures.', 'timeFrame': '6 months post-TAVI', 'description': 'Bacteremia is defined as having positive blood cultures (excluding all enterobacterales) registered in the Danish Microbiological Database at 6 months post-TAVI.'}, {'measure': 'Number of patients with acute kidney failure assessed by plasma creatinine levels.', 'timeFrame': '6 months post-TAVI', 'description': '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.'}, {'measure': 'Length of hospital stay', 'timeFrame': '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.', 'description': 'Length of hospital stay in relation to the TAVI-procedure'}, {'measure': 'Days-out-of-hospital from TAVI to 6 months', 'timeFrame': '6 months post-TAVI', 'description': 'Days-out-of-hospital from TAVI to 6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic Valve Stenosis', 'Aortic Valve Replacement', 'Transcatheter Aortic Valve Replacement', 'Aortic Valve', 'Cephalosporin', 'Ampicllin', 'Bacteremia', 'Per Procedure Prophylaxis'], 'conditions': ['Aortic Valve Stenosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe primary outcome of the PAPPI trial will be a composite of the following components within 6 months post TAVI:\n\n* Bacteremia (excluding all enterobacterales)\n* Death\n\nSecondary 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;\n\n* Bacteremia (excluding all enterobacterales)\n* Acute kidney failure\n* Death\n* Length of hospital stay\n* Days-out-of-hospital from TAVI to 6 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients \\> 18 years of age undergoing TAVI at sites in Denmark\n\nExclusion Criteria:\n\n* Patients who do not want to participate and have chosen to "opt-out" of the trial'}, 'identificationModule': {'nctId': 'NCT07442357', 'acronym': 'PAPPI', 'briefTitle': 'The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial', 'orgStudyIdInfo': {'id': 'p-2025-19665'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis', 'description': 'Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis', 'interventionNames': ['Drug: Beta-lactam antibiotic with spectrum for Enterococcus faecalis', 'Drug: Cephalosporin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cephalosporin (1st, 2nd, 3rd generation)', 'description': 'Cephalosporin (1st, 2nd, 3rd generation)', 'interventionNames': ['Drug: Cephalosporin']}], 'interventions': [{'name': 'Beta-lactam antibiotic with spectrum for Enterococcus faecalis', 'type': 'DRUG', 'description': 'Beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) add-on in combination with cephalosporin as per-procedural prophylaxis in TAVI', 'armGroupLabels': ['Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis']}, {'name': 'Cephalosporin', 'type': 'DRUG', 'description': 'Cephalosporin treatment', 'armGroupLabels': ['Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis', 'Cephalosporin (1st, 2nd, 3rd generation)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Copenhagen University Hospital, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Emil L Fosbøl, MD, PhD', 'role': 'CONTACT', 'email': 'emil.fosboel@regionh.dk', 'phone': '+ 45 35 45 63 40'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD', 'investigatorFullName': 'Emil Loldrup Fosbol', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}