[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535373":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":57,"collaborators":24,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":24,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":24,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Immediate reimplantation","EXPERIMENTAL","Reimplantation in same procedure as removal of device or shortly thereafter.",[13],"Other: Timing of reimplantation",{"label":15,"type":16,"description":17,"interventionNames":18},"Standart care","ACTIVE_COMPARATOR","Reimplantation of device in a second procedure at a later date, after infection has been stabilized\u002Fcleared",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Timing of reimplantation","Patients will be rendomized 1:1 by computer to recieve either standart care or intervention prior to removal of infected system",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Henning Henning","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Henning Bundgaard, MD, DMSc","CONTACT","35453534","henning.bundgaard@regionh.dk",{"name":36,"role":32,"phone":24,"phoneExt":24,"email":37},"Mia M Pries-Heje, MD, PhD","mia.marie.pries-heje.01@regionh.dk",[39],{"facility":40,"status":41,"city":42,"state":24,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Rigshospitalet","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":47,"coordinates":48},"Point",[49,50],12.56553,55.67594,{"lat":50,"lon":49},[53],{"name":54,"role":32,"phone":55,"phoneExt":24,"email":56},"Henning Bundgaard, MD","+45 3545 0512","Henning.Bundgaard@Regionh.DK",{"type":28,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Henning Bundgaard","Professor","100535373","phase-3-new-treatment-of-cardiac-device-infections-immediate-reimplantation-after-removal-of-infected-system-100535373",false,"NCT06250985","New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System","New Treatment of Cardiovascular Implantable Electronic Device (CIED) Infections; Immediate Reimplantation After Removal of Infected System","POET-PPM","Inclusion Criteria:\n\n* Culture positive or negative infection of a CIED acording to PI\n* Indication for removal of device\n* Clinical indication of device removal of existing device (concurrent left-sided IE is not a contraindication).\n* Indication for reimplantation of new device\n* A minimum of 3 days of sufficient antibiotic treatment (intravenous or oral) has been administered and\u002For culture negative antibiotic regimen have been adminstered until blood culture is examined.\n* stabilization criteria fulfilled i.e. I) negativ blood cultures, II) WBC \\\u003C 15 mia\u002FL or reduction of min. 25% and III) CRP \\\u003C50 or min. 25% reduction.\n\nExclusion Criteria:\n\n* Immunoincompetence (active chemotherapy or prednisone treatment \\> 20mg\u002Fday\n* Device-infection within last 6 months (relaps)\n* Septic shock\n* Stabilization criteria not fulfilled after 10 days of suficient antibiotic treatment","ALL","18 Years","110 Years",{"count":72,"type":73},176,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","The goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections, compared to standard care, i.e. reimplantation at a later procedure date.\n\nThe primary outcome is the occurence of the composite primary endpoint within 6 months of randomization consisting of\n\n* Death\n* Symptomatic embolism (systemic arterial embolism or pulmonary embolism)\n* Bacteremia og pocket-infection\n* Removal of a CIED due to new infection",[79],"Endocarditis, Bacterial","2025-10-06",{"date":82,"type":83},"2025-10-08","ACTUAL",{"date":85,"type":83},"2024-04-29",{"date":87,"type":73},"2037-12-31",{"name":5,"class":6},1]