[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aspergillosis-invasive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aspergillosis-invasive":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100618907","liposomal-amphotericin-b-in-invasive-aspergillosis-with-hepatic-dysfunction-100618907",false,"NCT07337720","Liposomal Amphotericin B in Invasive Aspergillosis With Hepatic Dysfunction","Liposomal Amphotericin B in Patients With Invasive Aspergillosis and Hepatic Dysfunction: A Prospective Study","Inclusion Criteria\n\nPatients must meet all of the following criteria to be eligible for enrollment:\n\n1. Willing to participate in the study and able to provide written informed consent;\n2. Hospitalized patients admitted to the intensive care unit (ICU);\n3. Age ≥ 18 years, with no restriction on sex;\n4. Proven or probable invasive aspergillosis (IA), defined as follows:\n\nProven IA\n\nProven IA is diagnosed if at least one of the following criteria is met:\n\n1. Histopathological or cytopathological evidence of invasive Aspergillus spp. hyphae in tissue specimens obtained from a sterile site or the lung (e.g., biopsy or needle aspiration), with confirmation by culture or polymerase chain reaction (PCR);\n2. Isolation of Aspergillus spp. by culture from a specimen obtained from a sterile site (e.g., biopsy or needle aspiration), with the lesion consistent with an infectious process.\n\nProbable IA\n\nProbable IA requires the presence of all of the following criteria:\n\n1. At least one host factor (e.g., COVID-19, influenza, solid malignancy, HIV infection with CD4 \\\u003C200 cells\u002FµL, decompensated liver cirrhosis, or moderate to severe chronic obstructive pulmonary disease \\[COPD\\]);\n2. At least one compatible clinical feature (e.g., fever ≥38.3 °C lasting ≥3 days, pleuritic chest pain, dyspnea, hemoptysis, or worsening respiratory failure despite appropriate antibacterial therapy);\n3. At least one compatible radiological finding (e.g., newly developed pulmonary infiltrates on chest computed tomography, or cavitary lesions not explained by other causes);\n4. At least one mycological criterion (e.g., positive culture for Aspergillus spp. from bronchoalveolar lavage fluid \\[BALF\\], serum galactomannan \\>0.5 optical density index \\[ODI\\], or BALF galactomannan ≥1.0 ODI).\n5. Concomitant hepatic dysfunction meeting at least one of the following conditions:\n\n   * Aminotransferase levels \\>3 times the upper limit of normal (ULN) and \\\u003C10 times ULN;\n   * Child-Pugh class A or B;\n6. Expected to receive antifungal therapy for ≥5 days.\n\nExclusion Criteria\n\nPatients meeting any of the following criteria will be excluded:\n\n1. Pregnant or breastfeeding women;\n2. Known allergy or hypersensitivity to amphotericin B or any of its formulations;\n3. Previous treatment with extracorporeal membrane oxygenation (ECMO);\n4. Expected life expectancy \\\u003C48 hours;\n5. Patients who, at the time of enrollment, are confirmed to require antifungal agents other than those specified in the study protocol;\n6. Presence of any of the following severe comorbid conditions that may interfere with assessment of study efficacy or safety:\n\n   * Acute liver failure or acute decompensation of chronic liver failure;\n   * Known or suspected active pulmonary tuberculosis, cystic fibrosis, lung abscess, empyema, or obstructive pneumonia;\n7. Severe renal impairment, defined as any of the following:\n\n   * Creatinine clearance (CrCL) \\\u003C16 mL\u002Fmin at enrollment;\n   * Requirement for hemodialysis, peritoneal dialysis, or other renal replacement therapy at enrollment;\n8. Participation in another clinical trial within 3 months prior to enrollment;\n9. Previous enrollment in this study;\n10. Any condition that may affect study compliance or outcome assessment (e.g., planned major surgery, or inability to comply with the study protocol due to disease severity or poor adherence);\n11. Any other condition deemed by the investigator to make the patient unsuitable for participation.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","Liposomal amphotericin B is an antifungal agent commonly used to treat invasive aspergillosis, a severe fungal infection associated with high mortality in critically ill patients. However, evidence regarding its safety and effectiveness in patients with hepatic dysfunction is limited.\n\nIn China, patients diagnosed with invasive aspergillosis complicated by hepatic dysfunction will be recruited from multiple centers. Eligible patients will receive treatment with liposomal amphotericin B according to the study protocol. The safety and effectiveness of liposomal amphotericin B in this patient population will be evaluated.\n\nThis study aims to provide clinical evidence to support antifungal treatment decisions for patients with invasive aspergillosis and impaired liver function.",[26],"Aspergillosis Invasive",[28,29,30,31,32],"Invasive Aspergillosis","Liposomal Amphotericin B","Hepatic Dysfunction","Critically Ill Patients","Antifungal Therapy","NOT_YET_RECRUITING","2026-01-04",{"date":36,"type":37},"2026-01-13","ACTUAL",{"date":39,"type":20},"2025-12-20",{"date":41,"type":20},"2027-03-20",{"name":43,"class":44},"Southeast University, China","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":17,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100549965","study-on-theraputic-drug-monitoring-and-phamacokinetics-of-isavuconazole-in-children-100549965","NCT06440915","Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children","Inclusion Criteria:\n\n* Patients who intend to take isavuconazole for the treatment of invasive mycosis;\n* Aged 0-18 years, gender unlimited;\n* The subject and his\u002Fher guardian are willing to comply with the procedures and operations specified in the study protocol;\n* The guardian of the subject and the subject of independent informed age are willing and able to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* The subject is known to be allergic to any azole antifungal therapy or other ingredients contained in the study drug;\n* The researcher believes that the condition of the child may interfere with study participation or other inappropriate conditions.",{"count":52,"type":20},200,[23],"The goal of this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. It will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. The main questions it aims to answer are:\n\nWhat is the plasma concentration after using isavuconazole in pediatric patients? What is the effective range of plasma concentration of isavuconazole in pediatric patients? What is the safe range of plasma concentration of isavuconazole in pediatric patients? Researchers will measure the plasma concentration of isavuconazole to see whether it is appropriate.\n\nParticipants will:\n\nTake drug isavuconazole as prescribed by the doctor;\n\n1mL of blood is drawn 30min before the next dose.",[26,56],"Mucormycosis","RECRUITING","2024-12-09",{"date":60,"type":37},"2024-12-13",{"date":62,"type":37},"2024-06-06",{"date":64,"type":20},"2026-06-30",{"name":66,"class":44},"Shanghai Children's Medical Center",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":67},"100560825","phase-4-individualized-first-maintenance-doses-of-voriconazole-through-a-multiparametric-algorithm-100560825","NCT06582186","Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm","Individualization of First Maintenance Doses of Voriconazole Using a Multiparametric Algorithm in Hematology Patients: a Prospective Single-arm Interventional Study","VORIPRECI","Inclusion Criteria:\n\n* adult patient suffering from haematological malignancy\n* followed in the clinical hematology department or in the hematology day hospital of the Grenoble Alps University Hospital\n* consenting to carrying out CYP2C19 genotyping\n* likely to start treatment with voriconazole (for curative or prophylactic purposes as part of care)\n* having signed a written consent to participate\n* affiliated to a social security system\n\nExclusion Criteria:\n\n* comedication with strong inhibitors\u002Finducers (valproic acid, phenytoin, carbamazepine, rifampicin)\n* Subject during exclusion period from another study,\n* Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman, parturient woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, persons subject to care psychiatric pursuant to articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, persons admitted to a health or social establishment for purposes other than research , minors, person subject to a legal protection measure or unable to express their consent)",{"count":77,"type":20},30,[79],"PHASE4","The goal of this interventional single-arm study is to evaluate the interest of a multiparametric algorithm for individualization of first voriconazole maintenance doses for improvement of initial voriconazole exposure in adult patients with haematological malignancies. The main objective it aims is to determine the percentage of patients with initial voriconazole trough concentrations in the therapeutic range after individualization of first maintenance doses.\n\nParticipants will benefited from individualization of first voriconazole maintenance doses through a previously developed and validated multiparametric algorithm (publication in progress) taking into account CYP2C19 genotype, C reactive protein level and age.",[26,82,83],"Fungal Infection","Hematologic Malignancy",[85,86,87],"model-informed precision dosing","single-arm prospective interventional study","Simon design","2024-08-29",{"date":90,"type":37},"2024-09-03",{"date":92,"type":20},"2024-10",{"date":94,"type":20},"2027-10",{"name":96,"class":44},"University Hospital, Grenoble"]