[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596583":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":32,"responsibleParty":52,"collaborators":18,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":18,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":18,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":80,"whyStopped":18,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Study: empirical treatment","EXPERIMENTAL","Empirical treatment to cover carbapenem-resistant enterobacterales",[13],"Other: Empirical treatment",[15],{"type":6,"name":16,"description":11,"armGroupLabels":17,"otherNames":18},"Empirical treatment",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Jiong Hu","Ruijin Hospital","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"jiong hu","CONTACT","86-13764313546","hj10709@rjh.com.cn",{"name":31,"role":27,"phone":18,"phoneExt":18,"email":18},"Ling Wang",[33],{"facility":34,"status":18,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Rui Jin Hospital","Shanghai","Shanghai Municipality","200025","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47,49,51],{"name":48,"role":27,"phone":28,"phoneExt":18,"email":29},"Jiong HU",{"name":50,"role":27,"phone":18,"phoneExt":18,"email":18},"Ling wang",{"name":48,"role":23,"phone":18,"phoneExt":18,"email":18},{"type":53,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100596583","prospective-study-evaluate-the-timing-of-empirical-treatment-for-carbapenem-resistant-bacterials-croeat-study-100596583",false,"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.","ALL","18 Years","75 Years",{"count":65,"type":66},91,"ESTIMATED","INTERVENTIONAL",[69],"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.",[72,73,74],"Carbapenem-resistant Enterobacterales","Neutropenia","Hematological Malignancies",[76,77,78,79],"carbapenem-resistant enterobacterales","hematological malignancies","neutropenia","empirical therapy","NOT_YET_RECRUITING","2025-06-24",{"date":83,"type":84},"2025-07-02","ACTUAL",{"date":86,"type":66},"2025-08-01",{"date":88,"type":66},"2026-06-30",{"name":5,"class":6},1]