[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620393":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":46,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":65,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"children and adolescent patients with hematological malignancies who have breakthrough IFD",null,"children and adolescent patients with hematological malignancies who have breakthrough IFD after receiving triazoles or echinocandins prophylaxis",[13],"Drug: Patients received the Drug: liposomal amphotericin B（AmBisome） for treatment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","Patients received the Drug: liposomal amphotericin B（AmBisome） for treatment","1. This is a single center, prospective ,single-arm and observational study.\n2. Patients who meet the inclusion and exclusion criteria receive liposomal amphotericin B (L-AmB)(AmBisome) for antifungal therapy.\n\nRegarding the combination therapy: During the research period, it is allowed to combine with other antifungal drugs in combination and accurately record them. Researchers determine it based on the severity of the underlying disease, the recovery of immune suppression, and clinical response.\n\nRegarding the sequential therapy: During the research period, it is allowed to accept sequential therapy with other antifungal drugs and accurately record them. Researchers determine it based on the severity of the underlying disease, the recovery of immune suppression, and clinical response.\n\nRegarding the surgical treatment: If the patient's condition permits, surgical treatment can be accepted and explained.\n\nDosage: All medication doses are to be administered in accordance with the drug",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Wenyu Yang, Doctor","CONTACT","+86 13821596186","yangwenyu@ihcams.ac.cn",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":10,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital","RECRUITING","Tianjin","Tianjin Municipality","China","CN",{"type":35,"coordinates":36},"Point",[37,38],117.17667,39.14222,{"lat":38,"lon":37},[41,44],{"name":42,"role":23,"phone":43,"phoneExt":10,"email":25},"wenyu Yang","+8613821596186",{"name":45,"role":23,"phone":10,"phoneExt":10,"email":10},"Yang",{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[49],{"name":50,"class":51},"Gilead Sciences","INDUSTRY","100620393","a-real-world-prospective-observational-study-on-the-efficacy-and-safety-of-l-ambliposomal-amphotericin-b-for-br--ifdbreakthrough-invasive-fungal-disease-in-children-and-adolescent-patients-with-hematological-malignancies-receiving-triazoles-or-echinocandins-prophylaxis-100620393",false,"NCT07357038","A Real-world Prospective Observational Study on the Efficacy and Safety of L-AmB(Liposomal Amphotericin B) for br- IFD(Breakthrough Invasive Fungal Disease) in Children and Adolescent Patients With Hematological Malignancies Receiving Triazoles or Echinocandins Prophylaxis","A Real-world Prospective Observational Study on the Efficacy and Safety of L-AmB for br- IFD in Children and Adolescent Patients With Hematological Malignancies Receiving Triazoles or Echinocandins Prophylaxis","Inclusion Criteria:\n\n* The children and adolescent patients with hematological malignancy received echinocandin\u002Ftriazole for antifungal prophylaxis and diagnosed with br-IFD.\n\n  1. Age: from 1 month to 18 years old.\n  2. Diagnosed patients with hematological malignancy.\n  3. Received echinocandin\u002Ftriazole for antifungal prophylaxis at least 7 days.\n  4. Br-IFD is defined as a proven, probable, and possible IFD diagnosed at least 7 days after the start of primary antifungal prophylaxis and by 7 days from the end of primary antifungal prophylaxis. Definitions of proven, probable and possible IFD based on the EORTC\u002FMSG 2020 criteria.\n  5. ECOG-PS(Eastern Cooperative Oncology Group Performance Status): 0-2 points.\n  6. There are no organ dysfunction restrictions during the screening period that limit the use of this protocol.\n  7. The guardian understands the research and signs written informed consent form.\n\nExclusion Criteria:\n\n* (a) Received AmB formulation for prophylaxis or treatment within the past 30 days.\n\n  (b) Confirmed allergy\u002Frapid onset severe allergic reaction\u002Fintolerance to L-AmB (c) Has a history of other tumors and has received any treatment for this tumor within the past 3 years (d) HIV, active hepatitis B and active hepatitis C virus or syphilis infection (e) Suffering from mental illness or other conditions that prevent cooperation with research, treatment, and monitoring requirements (f) Serum creatinine level 2 times the upper limit of normal; Liver transaminase or alkaline phosphatase levels 5 times the upper limit of normal, bilirubin levels 3 times the upper limit of normal (g) Researchers believe that patients who are not suitable for inclusion","ALL","1 Month","18 Years",{"count":63,"type":64},38,"ESTIMATED","12 Weeks","OBSERVATIONAL","The goal of this observational study is to evaluate the efficacy the favorable response rate and safety of L-AmB(liposomal amphotericin B) for the treatment of br-IFD(breakthrough invasive fungal disease) in Chinese children and adolescent patients with hematological malignancies receiving triazoles\u002Fechinocandins antifungal prophylaxis.\n\nThe main question it aims to answer is:\n\n1. Whether the L-AmB have the same efficacy in the treatment of br-IFD in Chinese children and adolescent with hematological malignancies who are receiving triazoles or echinocandins antifungal prophylaxis as in adults(compared with historical data)\n2. Whether L-AmB may have better renal safety in Chinese children and adolescent than in adults (compared with historical data).\n\nChinese children and adolescent with hematological malignancies will taking L-AmB as part of their regular medical care for br-IFD. The efficacy and safety data will be recorded.",[69],"Fungal Disease",[71,72,73,74],"malignant hematological diseases","breakthrough","invasive fungal disease","liposomal amphotericin B","2026-01-15",{"date":77,"type":78},"2026-01-21","ACTUAL",{"date":80,"type":78},"2025-09-30",{"date":82,"type":64},"2027-05-31",{"name":5,"class":6},1]