[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641346":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":34,"centralContacts":38,"locations":43,"responsibleParty":59,"collaborators":62,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":10,"enrollmentInfo":76,"targetDuration":10,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":94,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Sichuan Provincial People's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Liposomal Amphotericin B Cohort",null,"Solid organ transplant recipients with invasive fungal disease receiving liposomal amphotericin B therapy.",[13],"Drug: Liposomal Amphotericin B",{"label":15,"type":10,"description":16,"interventionNames":17},"Historical Control Cohort","Historical control patients with invasive fungal disease treated with alternative systemic antifungal regimens.",[18],"Drug: Alternative Systemic Antifungal Therapy",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Liposomal Amphotericin B","Liposomal amphotericin B administered for treatment of proven, probable, or possible invasive fungal disease in solid organ transplant recipients according to routine clinical practice. Dose adjustment and treatment duration are determined by treating physicians.",[9],[26],"L-AmB",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Alternative Systemic Antifungal Therapy","Alternative systemic antifungal agents including azoles, echinocandins, or other standard antifungal therapies administered according to routine clinical practice in historical control patients with invasive fungal disease.",[15],[32,33],"Azoles","Echinocandins",[35],{"name":36,"affiliation":5,"role":37},"Lingai Pan, MD","PRINCIPAL_INVESTIGATOR",[39],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":42},"CONTACT","+86 17708130236","panlingai2004@163.com",[44],{"facility":45,"status":10,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital","Chengdu","Sichuan","610072","China","CN",{"type":52,"coordinates":53},"Point",[54,55],104.06667,30.66667,{"lat":55,"lon":54},[58],{"name":36,"role":40,"phone":41,"phoneExt":10,"email":42},{"type":37,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Lingai Pan","Director, Organ Donation Program",[63],{"name":64,"class":65},"Beijing Science and Technology Innovation Medical Development Foundation","UNKNOWN","100641346","liposomal-amphotericin-b-for-invasive-fungal-disease-in-solid-organ-transplant-recipients-100641346",false,"NCT07656493","Liposomal Amphotericin B for Invasive Fungal Disease in Solid Organ Transplant Recipients","A Real-World Observational Study of the Effectiveness, Safety, and Therapeutic Drug Monitoring of Liposomal Amphotericin B in Solid Organ Transplant Recipients With Invasive Fungal Disease","LAMB-SOT","Inclusion Criteria:\n\n* Age 18 to 75 years.\n* Recipient of a solid organ transplant.\n* Diagnosis of invasive fungal disease (IFD) according to EORTC\u002FMSGERC criteria.\n* Receiving liposomal amphotericin B therapy as part of routine clinical care.\n* Provision of informed consent for prospective participants.\n\nExclusion Criteria:\n\n* Known hypersensitivity to amphotericin B formulations.\n* Severe hepatic dysfunction (ALT or AST \\>5× upper limit of normal, or total bilirubin \\>2× upper limit of normal).\n* Severe renal dysfunction requiring permanent discontinuation of antifungal therapy at baseline.\n* Pregnancy or breastfeeding.\n* Participation judged inappropriate by the investigator.","ALL","18 Years",{"count":77,"type":78},120,"ESTIMATED","OBSERVATIONAL","This real-world observational study aims to evaluate the effectiveness, safety, and therapeutic drug monitoring (TDM) of liposomal amphotericin B (L-AmB) in solid organ transplant recipients with invasive fungal disease (IFD). IFD is a major cause of morbidity and mortality in transplant recipients because of long-term immunosuppressive therapy and increased susceptibility to opportunistic fungal infections.\n\nThis is a single-center ambispective cohort study conducted at Sichuan Provincial People's Hospital. The study includes a prospective cohort of solid organ transplant recipients receiving L-AmB therapy and a historical control cohort treated with alternative systemic antifungal regimens. Clinical management and treatment decisions will be determined by treating physicians according to routine clinical practice, and no study-specific intervention will be introduced.\n\nThe study will collect information on demographic characteristics, transplant type, immunosuppressive regimens, fungal pathogens, infection sites, antifungal treatment strategies, laboratory findings, and clinical outcomes. Particular attention will be given to renal safety, electrolyte abnormalities, and therapeutic drug monitoring of liposomal amphotericin B. Plasma concentrations of L-AmB, treatment modifications, temporary treatment discontinuation, and concentration-related safety and effectiveness outcomes will be recorded during antifungal therapy.\n\nThe primary outcomes are the 28-day clinical response rate and 84-day all-cause mortality. Secondary outcomes include mycological clearance, acute kidney injury, electrolyte abnormalities, breakthrough fungal infection, treatment discontinuation due to adverse events, liposomal amphotericin B plasma concentrations, and the associations between L-AmB exposure and clinical outcomes or treatment-related toxicities.\n\nThe study is expected to provide real-world evidence regarding the effectiveness, safety, and pharmacokinetic characteristics of L-AmB in transplant recipients, support optimization of antifungal treatment strategies, and inform individualized dosing and monitoring approaches in this high-risk population.",[82,83,84],"Invasive Fungal Infection","Solid Organ Transplantation","Opportunistic Infections",[22,83,86,87,88,89,90,91,92,93],"Invasive Fungal Disease","Antifungal Therapy","Tacrolimus","Cyclosporine","Therapeutic Drug Monitoring","Drug-Drug Interaction","Real-World Study","Transplant Infection","NOT_YET_RECRUITING","2026-06-19",{"date":97,"type":98},"2026-06-24","ACTUAL",{"date":100,"type":78},"2026-07-01",{"date":102,"type":78},"2028-06-30",{"name":5,"class":6},1]