[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"opportunistic-infections\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:opportunistic-infections":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,82],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"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":20,"type":21},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.",[25,26,27],"Invasive Fungal Infection","Solid Organ Transplantation","Opportunistic Infections",[29,26,30,31,32,33,34,35,36,37],"Liposomal Amphotericin B","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":41,"type":42},"2026-06-24","ACTUAL",{"date":44,"type":21},"2026-07-01",{"date":46,"type":21},"2028-06-30",{"name":48,"class":49},"Sichuan Provincial People's Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":50},"100284461","early-phase-1-t-cell-therapy-of-opportunistic-cytomegalovirus-infection-100284461","NCT02982902","T Cell Therapy of Opportunistic Cytomegalovirus Infection","Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant","Inclusion Criteria:\n\n* Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration\n* Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met)\n\n  * Patients may have asymptomatic viremia (\\>1000 copies\u002Fml) OR presence of symptoms secondary to CMV infection, AND\n  * Patients must have ONE OF THE NEXT FOUR CRITERIA:\n\n    * Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold) or\n    * New, persistent and\u002For worsening CMV-related symptoms, signs and\u002For markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet, or\n    * Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet.\n    * Second recurrence of CMV viremia, CMV-related symptoms, signs and\u002For markers of end organ compromise.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3\n* Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women are excluded from this study.\n* Patients with opportunistic viral infections other than CMV.\n* Patients with active, grade 2-4, acute graft vs. host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (\\>0.5 mg\u002Fkg\u002Fday prednisone or its equivalent) as treatment\n* Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.\n* Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.\n\nDonor eligibility\n\n* Related donor of T cells must be at least partially HLA compatible, matching with recipient in at least 3\u002F6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this).\n* Must have evidence of a serologic response (i.e. be seropositive) against CMV.\n* Age ≥ 18 years\n* Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program\n* Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood","3 Months",{"count":60,"type":21},20,"INTERVENTIONAL",[63],"EARLY_PHASE1","The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV.\n\nAdoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).",[66,67,27],"Cytomegalovirus Infections","Hematopoietic Stem Cell Transplant",[69,70,71],"Immunotherapy","T-Cell Therapy","Lymphoproliferative Disorder","RECRUITING","2025-10-20",{"date":75,"type":42},"2025-10-22",{"date":77,"type":42},"2020-05-27",{"date":79,"type":21},"2028-08",{"name":81,"class":49},"Mari Dallas",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":89,"targetDuration":91,"studyType":22,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":50},"100243993","vicente-ferrer-hiv-cohort-study-100243993","NCT02454569","Vicente Ferrer HIV Cohort Study","VFHCS","Inclusion Criteria:\n\n* Positive serology for HIV\n\nExclusion Criteria:\n\n* Refuse to consent",{"count":90,"type":21},30000,"30 Years","The VFHCS is a long-term prospective cohort study of HIV infected patients from a resource-poor rural setting in India. The aim of the study is to use data collected from routine clinical care in order to describe the epidemiology of HIV and its related conditions in the investigators area, and to study the effectiveness of health interventions in a \"real-world\" setting (implementation and operational research).",[94,95,96,27,97],"HIV","Tuberculosis","Cryptococcosis","Noncommunicable Diseases","2023-03-28",{"date":100,"type":42},"2023-03-29",{"date":102,"type":4},"2009-09",{"date":104,"type":21},"2040-01",{"name":106,"class":49},"Rural Development Trust Hospital"]