[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574200":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":25,"studyPopulation":25,"armGroups":32,"interventions":45,"overallOfficials":54,"centralContacts":59,"locations":25,"responsibleParty":65,"collaborators":25,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":25,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":89,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":25},{"fullName":5,"class":6},"Capital Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"4-week favourable response rate","The percentage of patients with favourable response by 4 week. Favourable response is defined as lesion absorption in chest CT.","4 week",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"12-week mortality","Defined as the proportion of patients who died by 12 week.","12 week",{"measure":19,"description":20,"timeFrame":21},"24-week mortality","Defined as the proportion of patients who died by week 24.","24 week",{"measure":23,"description":24,"timeFrame":12},"Frequency of adverse events","Treatment-related adverse event frequency",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Single drug group","ACTIVE_COMPARATOR","Liposomal amphotericin B (AmBisome®)",[38],"Drug: Liposomal Amphotericin B",{"label":40,"type":41,"description":42,"interventionNames":43},"Combination therapy","EXPERIMENTAL","Liposomal amphotericin B (AmBisome®) combination with Isavuconazole",[44],"Drug: Combination therapy group",[46,50],{"type":47,"name":48,"description":42,"armGroupLabels":49,"otherNames":25},"DRUG","Combination therapy group",[40],{"type":47,"name":51,"description":52,"armGroupLabels":53,"otherNames":25},"Liposomal Amphotericin B","Liposomal amphotericin B (AmBisome®) alone",[34],[55],{"name":56,"affiliation":57,"role":58},"Bin Cao","China-Japan Friendship Hospital","PRINCIPAL_INVESTIGATOR",[60],{"name":61,"role":62,"phone":63,"phoneExt":25,"email":64},"Bin Cao, M.D.","CONTACT","+010086 15210682464","zhibo_liu1985@163.com",{"type":66,"investigatorFullName":56,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Professor","100574200","phase-4-antifungal-drugs-in-pulmonary-mucormycosis-100574200",false,"NCT06756191","Antifungal Drugs in Pulmonary Mucormycosis","Evaluation on Efficacy and Safety of Liposomal Amphotericin B(AmBisome® ) Combination with Isavuconazole Versus AmBisome® Alone for Treatment of Patients with Pulmonary Mucormycosis","Inclusion Criteria\n\n* Patients aged 18 years or older diagnosed with pulmonary mucormycosis (PM).\n* Individuals with Probable or proved PM, as indicated by clinical and radiological findings.\n\nExclusion Criteria:\n\n* Patients with a history of pulmonary mucormycosis (PM) who have previously been treated with amphotericin B for a duration exceeding 5 days.\n* Patients who have documented allergies to azoles or amphotericin B regimens\n* Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or bilirubin levels exceeding five times the upper limit of normal (ULN).\n* Patients with irreversible heart or liver failure, or those experiencing massive, fatal hemoptysis.\n* Patients who have experienced a myocardial infarction or cerebral infarction.\n* Patients currently receiving extracorporeal membrane oxygenation (ECMO) treatment.\n* Pregnant or breastfeeding individuals. 8.Patients with individual reasons that may prevent them from completing the treatment protocol.","ALL","18 Years",{"count":78,"type":79},312,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","Pulmonary mucormycosis (PM) poses a substantial clinical challenge, particularly among immunocompromised patients. The aim of the study is to determine the effectiveness and safety of administering AmBisome at a dose of 5mg\u002Fkg\u002Fday combined with isavuconazole versus using AmBisome for the management of pulmonary mucormycosis",[85],"Pulmonary Mucormycosis",[85,87,88],"Amphotericin B liposome","isavuconazole","NOT_YET_RECRUITING","2024-12-25",{"date":92,"type":93},"2025-01-01","ACTUAL",{"date":95,"type":79},"2025-01-10",{"date":97,"type":79},"2026-12-31",{"name":56,"class":6}]