[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599799":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":25,"overallStatus":39,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Meropenem and Pralurbactam","EXPERIMENTAL","Meropenem and Pralurbactam (180min infusion)",[13],"Drug: Meropenem and Pralurbactam",{"label":15,"type":16,"description":17,"interventionNames":18},"Best Available Therapy","ACTIVE_COMPARATOR","Subjects will receive Best Available Therapy (IV antibiotics)",[19],"Drug: Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","3g，q8h，180min infusion，Dose adjustments are available for participants with eGFR(mL\u002Fmin)",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)","The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Haihui Huang, PhD","CONTACT","021-52888195","Huanghaihui73@aliyun.com",[37],{"facility":38,"status":39,"city":40,"state":25,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Huashan Hospital, Fudan Universit","RECRUITING","Shanghai","China","CN",{"type":44,"coordinates":45},"Point",[46,47],121.45806,31.22222,{"lat":47,"lon":46},[50],{"name":51,"role":33,"phone":34,"phoneExt":25,"email":35},"HuangHai Hui",{"type":53,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","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":65,"type":66},80,"ESTIMATED","INTERVENTIONAL",[69],"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).",[72,73,74,75,76],"Hospital-acquired Bacterial Pneumonia (HABP)","Ventilator-associated Bacterial Pneumonia (VABP)","Complicated Intra-abdominal Infection (cIAI)","Complicated Urinary Tract Infection (cUTI)","Bloodstream Infection (BSI)","2025-07-27",{"date":79,"type":80},"2025-07-30","ACTUAL",{"date":82,"type":80},"2025-04-12",{"date":84,"type":66},"2027-04",{"name":5,"class":6},1]