[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"complicated-urinary-tract-infection-cuti\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:complicated-urinary-tract-infection-cuti":30},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100599799","phase-3-study-to-assess-the-efficacy-and-safety-of-meropenem-and-pralurbactam-in-carbapenem-resistant-enterobacteriaceae-infections-100599799",false,"NCT07089186","Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections","A Phase 3, Multicenter, Randomized, Open-label, Active-controlled, Parallel-design Clinical Study to Evaluate the Efficacy and Safety of Meropenem and Pralubactam for Injection in the Treatment of Carbapenem-Resistant Enterobacteriaceae Infections","Inclusion Criteria:\n\n* Hospitalized male or female≥18 and ≤80 years of age，\n* Participant must have a diagnosis of an infection (HABP\u002FVABP, cUTI, cIAI, BSI) due to confirmed Carbapenem-Resistant Enterobacteriaceae infection, requiring administration of IV antibacterial therapy\n* Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy\n* The estimated survival time is more than 28 days\n* Understand and abide by the research procedures and methods, voluntarily participate in this research, and sign an informed consent form\n\nExclusion Criteria:\n\n* Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)\n* Participant is expected to require more than 21 days of treatment\n* Acute Physiology and Chronic Health Evaluation (APACHE) II score \\>30 using the most recent available data\n* Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n* Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices","ALL","18 Years","80 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), and Bloodstream Infection (BSI).",[27,28,29,30,31],"Hospital-acquired Bacterial Pneumonia (HABP)","Ventilator-associated Bacterial Pneumonia (VABP)","Complicated Intra-abdominal Infection (cIAI)","Complicated Urinary Tract Infection (cUTI)","Bloodstream Infection (BSI)","RECRUITING","2025-07-27",{"date":35,"type":36},"2025-07-30","ACTUAL",{"date":38,"type":36},"2025-04-12",{"date":40,"type":21},"2027-04",{"name":42,"class":43},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY"]