[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carbapenem-resistant-enterobacterales\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carbapenem-resistant-enterobacterales":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,71],{"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":5},"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",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":4,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100617874","perianal-mbl-cre-colonization-and-infection-in-allogeneic-hematopoietic-stem-cell-transplant-patients-100617874","NCT07324291","Perianal MBL-CRE Colonization and Infection in Allogeneic Hematopoietic Stem Cell Transplant Patients","Prospective Cohort Study of Perianal MBL-CRE Colonization and Infection in Allogeneic Hematopoietic Stem Cell Transplant Recipients","Inclusion Criteria:\n\n* Adult patients (≥18 years) who received allogeneic hematopoietic stem cell transplantation;\n\nExclusion Criteria:\n\n* Engraftment failure.",{"count":57,"type":21},1000,"OBSERVATIONAL","The goal of this observational study is to characterize the clinical features of metallo-β-lactamase-producing carbapenem-resistant Enterobacterales (MBL-CRE) colonization and subsequent infection in patients after allogeneic hematopoietic stem cell transplantation (HSCT). The study aims to estimate the incidence of perianal MBL-CRE colonization, the proportion of subsequent infections, the associated risk factors, mortality, and the underlying antibiotic resistance mechanisms.\n\nThe main questions this study seeks to answer are:\n\n1. What is the incidence of perianal MBL-CRE colonization following allogeneic HSCT?\n2. Among colonized patients, what proportion subsequently develop MBL-CRE infections?\n3. What are the risk factors for colonization and infection, the patterns of antimicrobial resistance, and the mortality among infected patients? Participants will undergo perianal swab screening for CRE as part of their routine post-transplant care. MBL-CRE isolates identified from perianal swabs will undergo antimicrobial resistance genomic analysis to investigate bacterial transmission dynamics and resistance mechanisms.",[61,28],"ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION","2025-12-23",{"date":64,"type":41},"2026-01-07",{"date":66,"type":21},"2026-01",{"date":68,"type":21},"2027-06",{"name":70,"class":48},"Institute of Hematology & Blood Diseases Hospital, China",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100596583","prospective-study-evaluate-the-timing-of-empirical-treatment-for-carbapenem-resistant-bacterials-croeat-study-100596583","NCT07047352","Prospective Study Evaluate the Timing of Empirical Treatment for Carbapenem-resistant Bacterials (CROEAT Study)","A Multi-center Single Arm Prospective Study in Patients of Hematological Malignancies Colonized With Carbapenem-resistant Bacterials to Evaluate the Timing of Empirical Antibiotic Treatment (CROEAT Study)","Inclusion Criteria:\n\n* Patients with hematological malignancies receiving hospital treatment such as chemotherapy\u002Fimmunotherapy\u002Fhematopoietic stem cell transplantation;\n* Those with a recent history of CRO colonization or who have been screened for CRO once a week continuously since admission;\n* Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:\n\n  1. Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate\\>20% among recently hospitalized patients);\n  2. Presence of fever or other possible signs and symptoms of infection;\n  3. Neutropenia(ANC\\\u003C0.1×10\\^9\u002FL)expected to last for ≥7 days,and having any of the following:\n\n     * Gastrointestinal mucositis\u002Fperi-anal infection\u002Fintestinal obstruction;\n\n       * Shock or severe sepsis;\n\n         * Respiratory failure:deoxygenated PaO2\\\u003C60 mmHg or requiring mechanical ventilation;\n\n           * Disseminated intravascular coagulation;\n\n             * Altered mental status or psychiatric abnormalities;\n\n               * Congestive heart failure requiring treatment;\n\n                 * Arrhythmia requiring treatment;\n\n                   * Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).\n* The patient or their legal guardian has signed the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women;\n* Individuals who are expected to die within 14 days of hospitalization or have an expected hospital stay of less than 7 days;\n* Any conditions that the investigator believes may increase the risk to the patient;\n* Severe psychological or psychiatric disorders with poor estimated compliance;\n* The presence of any other conditions that the investigator deems unsuitable for participation in this study.","75 Years",{"count":80,"type":21},91,[82],"NA","In this study, we will evaluate the feasibility and clinical outcomes of risk adaptive empirical therapy to cover carbapenem resistance gram negative bacteria (CRO) in patients with hematological malignancies colonized with CRO. Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:\n\n1. Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate\\>20% among recently hospitalized patients);\n2. Presence of fever or other possible signs and symptoms of infection;\n3. Neutropenia(ANC\\\u003C0.1×10\\^9\u002FL)expected to last for ≥7 days,and having any of the following:\n\n   * Gastrointestinal mucositis\u002Fperi-anal infection\u002Fintestinal obstruction;\n\n     * Shock or severe sepsis;\n\n       * Respiratory failure:deoxygenated PaO2\\\u003C60 mmHg or requiring mechanical ventilation;\n\n         * Disseminated intravascular coagulation;\n\n           * Altered mental status or psychiatric abnormalities;\n\n             * Congestive heart failure requiring treatment;\n\n               * Arrhythmia requiring treatment;\n\n                 * Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).\n\nThe endpoints of study include incidence of blood-stream infection by CRO, incidence of all causes mortality, incidences of clinical and microbiology response.",[28,85,86],"Neutropenia","Hematological Malignancies",[36,88,89,90],"hematological malignancies","neutropenia","empirical therapy","2025-06-24",{"date":93,"type":41},"2025-07-02",{"date":95,"type":21},"2025-08-01",{"date":97,"type":21},"2026-06-30",{"name":99,"class":48},"Shanghai Jiao Tong University School of Medicine",1]