[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458361":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":76,"studyPopulation":68,"armGroups":77,"interventions":89,"overallOfficials":97,"centralContacts":102,"locations":110,"responsibleParty":213,"collaborators":215,"id":237,"slug":238,"hasResults":239,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":239,"sex":245,"minAge":246,"maxAge":68,"enrollmentInfo":247,"targetDuration":68,"studyType":250,"phases":251,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":133,"whyStopped":68,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},{"fullName":5,"class":6},"Zealand University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of patients with Blood stream infection (BSI)","Hospitalization for BSI","≤ 6 months after randomization",{"measure":14,"description":15,"timeFrame":12},"Number of patients with Severe blood culture negative infection","Hospitalization ≥ 3 days, or dies within 3 days, due to infection defined as: C-reactive protein (CRP) ≥ 75 and negative blood cultures, treated with iv antibiotics",[17,20],{"measure":18,"description":19,"timeFrame":12},"Number of patients with BSI or severe blood culture negative infection","Each of the components in the primary endpoint",{"measure":21,"description":22,"timeFrame":12},"Mortality","All-cause mortality",[24,27,30,33,36,39,42,45,48,51,54,57,60],{"measure":25,"description":26,"timeFrame":12},"Number of patients with Sepsis","Hospitalization due to sepsis or septic shock",{"measure":28,"description":29,"timeFrame":12},"Number of patients with Deep tissue infection","Infective endocarditis, osteomyelitis, and spondylodiscitis",{"measure":31,"description":32,"timeFrame":12},"Number of patients with Autoinfection","Frequency of BSI autoinfection",{"measure":34,"description":35,"timeFrame":12},"Number of patients with Clostridium difficile infection","Clostridium difficile infection - numbers and days of admission",{"measure":37,"description":38,"timeFrame":12},"Mortality due to infection - number of patients","Mortality due to infection",{"measure":40,"description":41,"timeFrame":12},"Number of CVC removals","CVC removal due to CVC infection",{"measure":43,"description":44,"timeFrame":12},"Use of Antibiotics in Difined Daily Doses","Total use of antibiotics in Defined Daily Doses",{"measure":46,"description":47,"timeFrame":12},"Healt-care economics","Health-care related economic consequences due to hospitalization and treatment of the disease",{"measure":49,"description":50,"timeFrame":12},"Number of patients with Extended Spectrum Beta-Lactamase (ESBL) infection","ESBL infections - number of patients and days of admission",{"measure":52,"description":53,"timeFrame":12},"Number of patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection","MRSA infections - number of patients and days of admission",{"measure":55,"description":56,"timeFrame":12},"Number of patients with Carbapenemase-Producing Organisms (CPO) infection","CPO infections - number og patients and days of admission",{"measure":58,"description":59,"timeFrame":12},"Number of patients with Vancomycin-resistant enterococci (VRE) infection","VRE infections - number of patients and days of admission",{"measure":61,"description":62,"timeFrame":12},"Number of patients with Cardiovascular events","Hospitalization with acute myocardial infarction, worsening heart failure or stroke",{"allocation":64,"interventionModel":65,"interventionModelDescription":66,"primaryPurpose":67,"observationalModel":68,"timePerspective":68,"maskingInfo":69},"RANDOMIZED","PARALLEL","Multicenter, randomized, single-blinded, placebo controlled study, with blinded endpoint evaluation","PREVENTION",null,{"masking":70,"maskingDescription":71,"whoMasked":72},"TRIPLE","Amoxicillin\u002Fplacebo is provided in identical containers. Amoxicillin and placebo tablets are looking similar, but by decision of the Danish Medicines Agency amoxicillin tablets must not be removed from the original folio packing prior to use. Clindamycin active and placebo tablets look similar (incapsulated), and are provided in identical containers. Study medicine will be provided by 1-2 nurses at each site, who are unblinded. The patients and care providers are blinded",[73,74,75],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","After being informed about the study and potential risks all eligible patients, giving written informed consent will be included in the study. At week 0 patients will be randomized in a single blinded manner (participants and care providers) in a 1:1 manner to receive 500\u002F125mg amoxicillin\u002Fclavulanic acid 30-120 minutes before each hemodialysis with a central venous catheter (CVC) as vascular access, or corresponding placebo. The timing of antibiotic administration has been established in a pilot-study in order to secure a sufficient concentration of antibiotics during the dialysis session. In case of side effects to amoxicillin\u002Fclavulanic acid, the prophylactic antibiotic will be shifted to 600mg clindamycin. Total treatment period with prophylactic antibiotics is 6 months, with a 1 year follow-up.",[78,84],{"label":79,"type":80,"description":81,"interventionNames":82},"Active","ACTIVE_COMPARATOR","Amoxicillin\u002Fclavulanic acid 500\u002F125mg, tablets, will be administered before each hemodialysis for 6 months",[83],"Drug: Amoxicillin Clavulanic 500\u002F125mg or placebo",{"label":85,"type":86,"description":87,"interventionNames":88},"Placebo","PLACEBO_COMPARATOR","Placebo tablets, similar to the active drug, will be administered before each hemodialysis for 6 months",[83],[90],{"type":91,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"DRUG","Amoxicillin Clavulanic 500\u002F125mg or placebo","Prophylactic antibiotic treatment",[79,85],[96],"Aurobindo",[98],{"name":99,"affiliation":100,"role":101},"Niels E Bruun, Professor","Dept. cardiology, Zealand University Hospital, Roskilde, Denmark","PRINCIPAL_INVESTIGATOR",[103,107],{"name":99,"role":104,"phone":105,"phoneExt":68,"email":106},"CONTACT","+4525159309","nbru@regionsjaelland.dk",{"name":108,"role":104,"phone":68,"phoneExt":68,"email":109},"Kasper K Iversen, Professor","Kasper.Karmark.Iversen@regionh.dk",[111,131,143,156,170,184,199],{"facility":112,"status":113,"city":114,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"Rigshospitalet","NOT_YET_RECRUITING","Copenhagen","Capital Region","2100","Denmark","DK",{"type":120,"coordinates":121},"Point",[122,123],12.56553,55.67594,{"lat":123,"lon":122},[126,129],{"name":127,"role":104,"phone":68,"phoneExt":68,"email":128},"Marianne Rix, Consultant","Marianne.Rix@regionh.dk",{"name":130,"role":104,"phone":68,"phoneExt":68,"email":68},"Anne-Lise Kamper, Consultant",{"facility":132,"status":133,"city":114,"state":115,"zip":134,"country":117,"countryCode":118,"cosmosGeoPoint":135,"geoPoint":137,"contacts":138},"Herlev-Gentofte Hospital","RECRUITING","2730",{"type":120,"coordinates":136},[122,123],{"lat":123,"lon":122},[139,142],{"name":140,"role":104,"phone":68,"phoneExt":68,"email":141},"Henrik P Hansen, Consultant","Henrik.Post.Hansen@regionh.dk",{"name":108,"role":104,"phone":68,"phoneExt":68,"email":68},{"facility":144,"status":113,"city":145,"state":115,"zip":146,"country":117,"countryCode":118,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"North Zealand Hospital Hillerød","Hillerød","3400",{"type":120,"coordinates":148},[149,150],12.30081,55.92791,{"lat":150,"lon":149},[153],{"name":154,"role":104,"phone":68,"phoneExt":68,"email":155},"Marianne Bertelsen, Consultant","marianne.camilla.bertelsen@regionh.dk",{"facility":157,"status":113,"city":158,"state":159,"zip":160,"country":117,"countryCode":118,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Aarhus University Hospital","Aarhus","Middle Region","8200",{"type":120,"coordinates":162},[163,164],10.21076,56.15674,{"lat":164,"lon":163},[167],{"name":168,"role":104,"phone":68,"phoneExt":68,"email":169},"Jens D Jensen, Consultant","jenjesen@rm.dk",{"facility":171,"status":133,"city":172,"state":173,"zip":174,"country":117,"countryCode":118,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Aalborg University Hospital","Aalborg","North Region","9100",{"type":120,"coordinates":176},[177,178],9.9187,57.048,{"lat":178,"lon":177},[181],{"name":182,"role":104,"phone":68,"phoneExt":68,"email":183},"Bo Madsen, Consultant","bom@rn.dk",{"facility":185,"status":133,"city":186,"state":187,"zip":188,"country":117,"countryCode":118,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"ZUH Roskilde","Roskilde","Region Sjælland","4000",{"type":120,"coordinates":190},[191,192],12.08035,55.64152,{"lat":192,"lon":191},[195,196],{"name":99,"role":104,"phone":105,"phoneExt":68,"email":106},{"name":197,"role":104,"phone":68,"phoneExt":68,"email":198},"Rikke Borg, Consultant","rbor@regionsjaelland.dk",{"facility":200,"status":133,"city":201,"state":202,"zip":203,"country":117,"countryCode":118,"cosmosGeoPoint":204,"geoPoint":208,"contacts":209},"Odense University Hospital","Odense","Region South","5000",{"type":120,"coordinates":205},[206,207],10.38831,55.39594,{"lat":207,"lon":206},[210],{"name":211,"role":104,"phone":68,"phoneExt":68,"email":212},"Per B Jensen, Consultant","Per.Bruno.Jensen@rsyd.dk",{"type":214,"investigatorFullName":68,"investigatorTitle":68,"investigatorAffiliation":68,"oldNameTitle":68,"oldOrganization":68},"SPONSOR",[216,218,220,222,224,225,226,228,230,232,233,235],{"name":217,"class":6},"Herlev Hospital",{"name":219,"class":6},"Rigshospitalet, Denmark",{"name":221,"class":6},"Holbaek Sygehus",{"name":223,"class":6},"Nordsjaellands Hospital",{"name":200,"class":6},{"name":157,"class":6},{"name":227,"class":6},"Kolding Sygehus",{"name":229,"class":6},"Gødstrup Hospital",{"name":231,"class":6},"Viborg Regional Hospital",{"name":171,"class":6},{"name":234,"class":6},"Esbjerg Hospital - University Hospital of Southern Denmark",{"name":236,"class":6},"Hospital of Southern Jutland","100458361","prophylactic-antibiotic-treatment-in-hemodialysis-100458361",false,"NCT05248620","Prophylactic Antibiotic Treatment in Hemodialysis","Prophylactic Antibiotic Treatment in End Stage Kidney Disease and Central Venous Catheter as Hemodialysis Vascular Access","PANTHEM","Inclusion Criteria:\n\n* End Stage Kidney Disease (ESKD) patients who receive an uncuffed or cuffed CVC for expected chronic HD, regardless of previous ESKD treatment modality (PD or KTX) and hemodialysis access (AV-fistula or AV-graft))\n* ≥18 years\n* Ability to understand the study background, risk and benefit of treatment and to give written informed consent\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Known intolerance to beta-lactam antibiotics and clindamycin\n* Active infection treated with antibiotics\n* Breastfeeding\n* Pregnancy. In women of childbearing age, an approved birth control must be ensured at least 1 month before and during all the 6 months of antibiotic\u002Fplacebo treatment.\n\nPatients may be rescreened later i.e. within a time period of one month from start of HD, if exclusion criteria are reversible.","ALL","18 Years",{"count":248,"type":249},800,"ESTIMATED","INTERVENTIONAL",[252],"NA","The purpose of this study is to assess the efficacy of prophylactic antibiotic treatment on blood stream infections and severe culture negative infections, in patients on newly started hemodialysis(HD), with a central venous catheter as vascular access.",[255],"Hemodialysis",[257,258,259,255,260],"Blood stream infections","Severe culture negative infections","Central venous catheter","Antibiotic prophylaxis","2026-09-07",{"date":263,"type":264},"2026-09-10","ACTUAL",{"date":266,"type":264},"2022-02-14",{"date":268,"type":249},"2029-05",{"name":5,"class":6},7]