[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cre-colonization\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cre-colonization":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100651431","phase-3-targeted-versus-standard-peri-operative-antibiotic-prophylaxis-in-patients-colonized-with-carbapenemase-producing-enterobacterales-undergoing-liver-transplantation-100651431",false,"NCT07759453","Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase Producing Enterobacterales Undergoing Liver Transplantation","Targeted Versus Standard Peri-operative Antibiotic Prophylaxis in Patients Colonized With Carbapenemase-producing Enterobacterales Undergoing Liver Transplantation: a Stepped Wedge Cluster Randomization Trial","TAILOR","Inclusion Criteria:\n\n* Adult (≥18 years) patients colonized with Carbapenemase-Producing Enterobacterales (CPE) undergoing liver transplantation (LT)\n* Informed consent signed by the enrolled patients\n\nExclusion Criteria:\n\n* Active infection from any Gram-negative bacteria at the time of LT\n* High risk of donor-derived CPE infection (e.g., donors known to be colonized or infected with CPE at the time of death, or CPE isolated from donor blood or preservation fluid samples)\n* Hypersensitivity to the active substance or to any of the excipients\n* Pregnancy and breastfeeding\n* Participation in a clinical trial in which an investigational drug was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer.\n* History of severe immediate hypersensitivity reactions (e.g., anaphylaxis) to beta-lactam agents (e.g., cephalosporins, carbapenems, or monobactams).\n* Colonization by strains resistant to all Investigational Medicinal Products (IMPs)","ALL","18 Years",{"count":20,"type":21},168,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter stepped-wedge cluster randomized trial, conducted over a 2-year period at three hospitals. The trial is structured into four phases, each lasting six months. During phase 1 (pre-rollout), all hospitals will use standard antibiotic prophylaxis for all patients. In each of phases 2 to 4, one hospital will switch to targeted antibiotic prophylaxis, so that by phase 4 all hospitals will be using it. The order in which hospitals switch is determined by computer-generated randomization performed centrally by an independent statistician, ensuring each hospital has an equal chance of switching at any given phase and minimizing selection bias.\n\nThe goal of this clinical trial is to learn whether targeted antibiotic prophylaxis works better than standard antibiotic prophylaxis at preventing infections in liver transplant patients who carry resistant bacteria called CPE (carbapenemase-producing Enterobacterales). It will also learn about the effects of these antibiotics on gut bacteria.\n\nThe main questions it aims to answer are:\n\n* Does targeted antibiotic prophylaxis reduce the number of CPE infections occurring in the first two weeks after liver transplant, compared to standard prophylaxis?\n* How do targeted and standard antibiotic prophylaxis affect the gut microbiome after transplant?\n* Is there a link between achieving optimal antibiotic blood levels and the risk of developing an infection after transplant?\n\nResearchers will compare targeted antibiotic prophylaxis (chosen based on the specific bacteria each patient carries) to standard antibiotic prophylaxis (used routinely at each hospital) to see which approach better prevents infection.\n\nThis study does not involve the administration of any drugs or instrumental examinations beyond those already part of standard clinical care at each center. However, additional blood tests will be performed by collecting one extra blood sample (and a bile sample, if the patient has a Kehr's tube, which is a drain placed in the bile duct after surgery) during blood draws already scheduled as part of routine clinical practice, in order to measure drug levels in the blood. Stool samples will also be collected specifically for the study to investigate the gut microbiome.",[27,28,29],"Liver Transplant","Carbapenem-resistant Enterobacterales","CRE Colonization",[31,32,33,34,35,36],"CRE colonization","liver transplant","stepped-wedge cluster randomized trial","therapeutic drug monitoring","gut microbiome","carbapenem-resistant enterobacterales","NOT_YET_RECRUITING","2026-08-06",{"date":40,"type":41},"2026-08-12","ACTUAL",{"date":43,"type":21},"2026-10-01",{"date":45,"type":21},"2029-09-30",{"name":47,"class":48},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",3]