[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626955":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":37,"studyPopulation":29,"armGroups":38,"interventions":48,"overallOfficials":29,"centralContacts":58,"locations":64,"responsibleParty":135,"collaborators":29,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":141,"sex":146,"minAge":147,"maxAge":29,"enrollmentInfo":148,"targetDuration":29,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":67,"whyStopped":29,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":173},{"fullName":5,"class":6},"Copenhagen University Hospital, Rigshospitalet","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"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.\n\nDeath is defined as being registered as deceased in the Danish Civil Registration System at 6 months post-TAVI.","6 months post-TAVI",[14,17,20,23,27],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",{"measure":24,"description":25,"timeFrame":26},"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.",{"measure":28,"description":28,"timeFrame":12},"Days-out-of-hospital from TAVI to 6 months",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","CROSSOVER","Prospective, crossover, cluster-randomized study","PREVENTION",{"masking":36,"maskingDescription":29,"whoMasked":29},"NONE","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",[39,45],{"label":40,"type":41,"description":40,"interventionNames":42},"Cephalosporin (1st, 2nd or 3rd generation) + betalactam with spectrum for Enterococcus faecalis","ACTIVE_COMPARATOR",[43,44],"Drug: Beta-lactam antibiotic with spectrum for Enterococcus faecalis","Drug: Cephalosporin",{"label":46,"type":41,"description":46,"interventionNames":47},"Cephalosporin (1st, 2nd, 3rd generation)",[44],[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":29},"DRUG","Beta-lactam antibiotic with spectrum for Enterococcus faecalis","Beta-lactam antibiotic with spectrum for Enterococcus faecalis (e.g. ampicillin 2g) add-on in combination with cephalosporin as per-procedural prophylaxis in TAVI",[40],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":29},"Cephalosporin","Cephalosporin treatment",[40,46],[59],{"name":60,"role":61,"phone":62,"phoneExt":29,"email":63},"Emil L Fosbøl, MD, PhD","CONTACT","+ 45 35 45 63 40","emil.fosboel@regionh.dk",[65,82,95,106,119],{"facility":66,"status":67,"city":68,"state":29,"zip":29,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Aalborg University Hospital","RECRUITING","Aalborg","Denmark","DK",{"type":72,"coordinates":73},"Point",[74,75],9.9187,57.048,{"lat":75,"lon":74},[78],{"name":79,"role":61,"phone":80,"phoneExt":29,"email":81},"Ashkan Eftekhari","+45 20 74 88 25","asef@rn.dk",{"facility":83,"status":67,"city":84,"state":29,"zip":29,"country":69,"countryCode":70,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Aarhus University Hospital","Aarhus",{"type":72,"coordinates":86},[87,88],10.21076,56.15674,{"lat":88,"lon":87},[91],{"name":92,"role":61,"phone":93,"phoneExt":29,"email":94},"Jonas Agerlund Povlsen","+45 4013 8742","jonapovl@rm.dk",{"facility":5,"status":67,"city":96,"state":29,"zip":29,"country":69,"countryCode":70,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Copenhagen",{"type":72,"coordinates":98},[99,100],12.56553,55.67594,{"lat":100,"lon":99},[103],{"name":104,"role":61,"phone":105,"phoneExt":29,"email":63},"Emil L Fosbøl","+4535456340",{"facility":107,"status":67,"city":108,"state":29,"zip":29,"country":69,"countryCode":70,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Odense University Hospital","Odense",{"type":72,"coordinates":110},[111,112],10.38831,55.39594,{"lat":112,"lon":111},[115],{"name":116,"role":61,"phone":117,"phoneExt":29,"email":118},"Marlene Tofterup","+45 29240987","Marlene.Tofterup@rsyd.dk",{"facility":120,"status":121,"city":122,"state":29,"zip":29,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Skåne University Hospital Lund","NOT_YET_RECRUITING","Lund","Sweden","SE",{"type":72,"coordinates":126},[127,128],13.19321,55.70584,{"lat":128,"lon":127},[131],{"name":132,"role":61,"phone":133,"phoneExt":29,"email":134},"Sasha Koul","+46 46 17 10 00","sasha.koul@med.lu.se",{"type":136,"investigatorFullName":137,"investigatorTitle":138,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Emil Loldrup Fosbol","Professor, MD, PhD","100626955","the-per-procedural-antibiotic-prophylaxis-in-patients-undergoing-transcatheter-aortic-valve-implantation-trial-100626955",false,"NCT07442357","The Per-procedural Antibiotic Prophylaxis in Patients Undergoing Transcatheter Aortic Valve Implantation Trial","PAPPI","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","ALL","18 Years",{"count":149,"type":150},1986,"ESTIMATED","INTERVENTIONAL",[153],"NA","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.",[156],"Aortic Valve Stenosis",[156,158,159,160,55,161,162,163],"Aortic Valve Replacement","Transcatheter Aortic Valve Replacement","Aortic Valve","Ampicllin","Bacteremia","Per Procedure Prophylaxis","2026-10-02",{"date":166,"type":167},"2026-10-05","ACTUAL",{"date":169,"type":167},"2026-10-01",{"date":171,"type":150},"2030-03-31",{"name":5,"class":6},5]