[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531008":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":11,"studyPopulation":11,"armGroups":47,"interventions":58,"overallOfficials":11,"centralContacts":66,"locations":72,"responsibleParty":91,"collaborators":11,"id":93,"slug":11,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":11,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":11,"enrollmentInfo":101,"targetDuration":11,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":11,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Fujian Shengdi Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluate overall success (mycological eradication and resolution of systemic signs attributable to candidemia and\u002For invasive candidiasis [IC]) of HRS9432 IV in subjects with candidemia and\u002For IC in the Microbiological Intent-to-treat (mITT) population",null,"Day 14",[14,17,20,22,25,28,31,34],{"measure":15,"description":11,"timeFrame":16},"Evaluate overall success (mycological eradication and resolution of systemic signs attributable to candidemia and\u002For IC) of HRS9432 IV in the mITT population","Day 5, Day 28, End of treatment(≤2 days of last dose) and End of Study (Day 56±3 days)]",{"measure":18,"description":11,"timeFrame":19},"Evaluate clinical cure as assessed by the Investigator for HRS9432 IV in the mITT population","Day 5, Day 14, Day 28, End of Treatment (≤2 days of last dose) and End of Study (Day 56±3 days)",{"measure":21,"description":11,"timeFrame":19},"Evaluate mycological success(eradication) of HRS9432 IV in the mITT population",{"measure":23,"description":11,"timeFrame":24},"Evaluate All cause Mortality in the mITT population","Day 28 and End of Study (Day 56±3 days)",{"measure":26,"description":11,"timeFrame":27},"The time when two consecutive negative candida cultures occurred for the first time with an interval of ≥12h in the mITT population","Day1 through End of Study (Day 56±3 days)",{"measure":29,"description":11,"timeFrame":30},"Percentage of Participants with mycological recurrence in the mITT population","End of Treatment (≤2 days of last dose) andEnd of Study (Day 56±3 days)",{"measure":32,"description":11,"timeFrame":33},"Time of the first mycological recurrence in the mITT population","Day1 through End of Study (Day 56±3 days",{"measure":35,"description":11,"timeFrame":27},"Number of Participants With Adverse Events and severity",{"allocation":37,"interventionModel":38,"interventionModelDescription":11,"primaryPurpose":39,"observationalModel":11,"timePerspective":11,"maskingInfo":40},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":41,"maskingDescription":11,"whoMasked":42},"QUADRUPLE",[43,44,45,46],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[48,53],{"label":49,"type":50,"description":11,"interventionNames":51},"HRS9432","EXPERIMENTAL",[52],"Drug: HRS9432",{"label":54,"type":55,"description":11,"interventionNames":56},"Caspofungin Acetate for Injection","ACTIVE_COMPARATOR",[57],"Drug: Caspofungin Acetate for Injection",[59,63],{"type":60,"name":49,"description":61,"armGroupLabels":62,"otherNames":11},"DRUG","Dosing frequency: intravenously once week",[49],{"type":60,"name":54,"description":64,"armGroupLabels":65,"otherNames":11},"Dosing frequency: D1 70mg，followed by 50mg intravenously once daily",[54],[67],{"name":68,"role":69,"phone":70,"phoneExt":11,"email":71},"Xiaopeng Wang","CONTACT","+86-182-6038-7118","xiaopeng.wang@hengrui.com",[73],{"facility":74,"status":75,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"The First Affiliated Hospital Of University Of South China","RECRUITING","Hengyang","Hunan","421001","China","CN",{"type":82,"coordinates":83},"Point",[84,85],112.61888,26.88946,{"lat":85,"lon":84},[88],{"name":89,"role":90,"phone":11,"phoneExt":11,"email":11},"Feng Wen","PRINCIPAL_INVESTIGATOR",{"type":92,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100531008",false,"NCT06194201","A Trial of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and\u002For Invasive Candidiasis","A Multi-centre, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase II Study to Evaluate the Efficacy and Safety of Intravenous HRS9432 in the Treatment of Subjects With Candidemia and\u002For Invasive Candidiasis","Inclusion Criteria:\n\n1. Males or females ≥18 years；\n2. Established or clinical diagnosis of candidemia and\u002For IC ；\n3. Present of 1 or more systemic signs attribute to candidemia and\u002For IC 4 days prior to randomization;\n4. Women of childbearing potential or male subjects whose partner is a fertile female agree to use highly effective form of contraception from the time of signed ICF till 6 months after end of treatment；\n5. Able and willing to provide a written informed consent\n\nExclusion Criteria:\n\n1. Any of the following forms of IC: including osteomyelitis, endocarditis or myocarditis, meningitis, endophthalmitis, or any central nervous system infection, urinary tract infection or chronic disseminated candidiasis；\n2. Severe hepatic impairment in subjects with a history of chronic cirrhosis；\n3. History of severe ataxia, tremor, or neuropathy or a diagnosis of multiple sclerosis or a movement;\n4. Laboratory abnormalities in baseline specimens obtained at screening;\n5. ECG with clinical significance and may cause obvious safety risk to the subjects at screening;\n6. Received systemic treatment with an antifungal agent at approved doses for treatment of candidemia or IC for \\>48 hours;\n7. Vascular catheter or device that cannot be removed, or abscess that cannot be drained, and may be the source of candidemia or IC;\n8. A history of drug use, alcohol, or drug abuse within 1 year prior to randomization;\n9. Participated in, any other clinical study involving the administration of active investigational or experimental medication prior to the randomization, or 5 half-lives, whichever is longer, prior to Screening;\n10. Females who are in gestation or lactating period or planned pregnancy during the study\n11. Known history of hypersensitivity or allergic reaction to HRS9432, caspofungin etc echinocandins drugs;\n12. In the judgment of the Investigator, other reasons unsuitable for study.","ALL","18 Years",{"count":102,"type":103},40,"ESTIMATED","INTERVENTIONAL",[106],"PHASE2","The Purpose of this study is to evaluate the efficacy and safety of intravenous HRS9432 in patients with candidemia and\u002For invasive candidiasis",[109],"Patients With Candidemia and\u002For Invasive Candidiasis","2024-11-15",{"date":112,"type":113},"2024-11-18","ACTUAL",{"date":115,"type":113},"2024-04-27",{"date":117,"type":103},"2026-06",{"name":5,"class":6},1]