[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635926":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":40,"collaborators":11,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":11,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":67,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Amphotericin B Treatment","EXPERIMENTAL",null,[13],"Drug: Amphotericin B",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Amphotericin B","Amphotericin B is a polyene antifungal drug used to treat breakthrough fungal infections. The dosage and duration will be determined based on pathogen results and clinical guidelines.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Rui Ma","CONTACT","+86 18834948122","marui_pku_ed@163.com",[27],{"facility":5,"status":11,"city":28,"state":29,"zip":11,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Beijing","Beijing Municipality","China","CN",{"type":33,"coordinates":34},"Point",[35,36],116.39723,39.9075,{"lat":36,"lon":35},[39],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Xiao-Jun Huang","Professor","100635926","amphotericin-b-for-breakthrough-fungal-infections-after-triazole-prophylaxis-in-hematological-patients-100635926",false,"NCT07559032","Amphotericin B for Breakthrough Fungal Infections After Triazole Prophylaxis in Hematological Patients","A Multicenter, Prospective, Observational Study to Evaluate the Efficacy and Safety of Amphotericin B in the Treatment of Breakthrough Invasive Fungal Disease in Hematological Patients Receiving Triazole Prophylaxis","Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Diagnosed with hematological diseases and receiving triazole prophylaxis.\n3. Confirmed or suspected breakthrough invasive fungal disease (IFD) according to EORTC\u002FMSG 2020 criteria.\n4. Able to understand and sign the informed consent form voluntarily.\n\nExclusion Criteria:\n\n1. Severe liver or renal dysfunction (ALT\u002FAST \\> 3×ULN, Cr \\> 2×ULN).\n2. Known allergy to amphotericin B or any component of the study drug.\n3. Pregnant or lactating women.\n4. Severe underlying diseases with expected survival \\\u003C 3 months.","ALL","18 Years",{"count":54,"type":55},15,"ESTIMATED","INTERVENTIONAL",[58],"NA","The goal of this clinical trial is to learn if amphotericin B works to treat breakthrough invasive fungal disease (IFD) in patients with hematological diseases who have received azole-based prophylaxis. It will also learn about the safety of amphotericin B in this population.\n\nThe main questions it aims to answer are:\n\n1. What is the overall response rate (complete remission + partial remission) of amphotericin B in treating breakthrough IFD after azole prophylaxis?\n2. What medical problems do participants have when taking amphotericin B?\n3. What is the 6-week (42-day) overall survival rate after starting treatment?\n\nThis is a single-arm, prospective study. Participants will:\n\n1. Receive intravenous liposomal amphotericin B (3-5 mg\u002Fkg daily) for 4-6 weeks.\n2. Undergo weekly clinical and laboratory assessments, including serum G\u002FGM tests, microbiology tests, and imaging (CT) at 2, 4, and 6 weeks.\n3. Have safety monitoring including liver and kidney function, electrolytes, and ECG.\n4. Be followed for treatment response and survival.",[61],"Invasive Fungal Disease",[63,64,65,17,66],"Breakthrough fungal infection","Invasive fungal disease","Triazole prophylaxis","Hematological diseases","NOT_YET_RECRUITING","2026-04-26",{"date":70,"type":71},"2026-04-30","ACTUAL",{"date":73,"type":55},"2026-04",{"date":75,"type":55},"2028-12-31",{"name":5,"class":6},1]