Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing...
Acute Myeloid LeukemiaAdult Acute Monoblastic Leukemia26 moreThis randomized phase III trial compares the effectiveness of caspofungin to fluconazole in preventing invasive fungal infections in patients receiving chemotherapy for acute myeloid leukemia (AML). Antifungal prophylaxis is considered standard of care in children and adults with prolonged neutropenia after chemotherapy for AML however the ideal antifungal agent for prophylaxis in children is not known. Caspofungin has activity against yeast and some molds while fluconazole coverage is limited to just yeasts. Adult randomized trials suggest that agents with activity against yeasts and molds are more effective than those with just activity against yeasts. There are limited data to answer this comparative question in children. This study will establish much needed pediatric data to guide clinical decision making on optimal antifungal prophylaxis.
A Bioequivalence Study of APX001 High-load and Low-load Tablets
Invasive Fungal InfectionsA study to learn about the bioequivalence (the biochemical similarity of two medicines that share the same active ingredient and desired outcome for patients) of the study medicine called APX001 in healthy participants.
Liposomal Amphotericin B With or Without Sargramostim in Treating Patients With Invasive Fungal...
InfectionRATIONALE: Drugs like liposomal amphotericin B may be able to relieve fungal infection which can be a side effect of chemotherapy. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether receiving liposomal amphotericin B plus sargramostim is more effective than receiving liposomal amphotericin B alone in treating patients with invasive fungal infection. PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of liposomal amphotericin B with or without sargramostim in treating patients with invasive fungal infection.
Pharmacokinetics and Safety of AmBisome and DKF-5122
Invasive Fungal InfectionsNeutropenic FeverThe purpose of the study is to assess the Safety and Pharmacokinetic Characteristics of AmBisome and DKF-5122
Efficacy and Safety of Micafungin for Injection in Prevention and Treatment of Fungal Infection...
Hematological Tumors Patients With High Risk Factors of Invasive Fungal DiseaseThis is a multi-center, prospective, open, observational and optimal clinical research to evaluate the clinical effectiveness and safety of different doses of micafungin sodium for injection in patients with hematological tumors.
Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy
Invasive Fungal InfectionsThis is a phase IV pragmatic, multicentre, randomised, simple-blind, parallel arm, centre-stratified clinical trial. The main objective is to compare efficiency of voriconazole preemptive genotyping strategy, compared with routine practice.
Caspofungin Based Combined Anti-fungal Therapy for Proven or Probable Invasive Fungal Infection...
LeukemiaTransplantation1 moreIn this prospective phase II observational study, we plan to assess the efficacy and tolerability of caspofungin based combined anti-fungal therapy for proven or probable IFI in a group of patients received allo-HSCT transplantation with high risk of IFI: HLA matched unrelated donor or mismatched donor conditioning with ATG containing regimen or present III-IV aGVHD or extensive GVHD undergoing high-dose steroid treatment.
Voriconazole Trough Plasma Levels : Genetic Polymorphism, Efficacy, Safety in Patients With Hematologic...
Invasive Fungal InfectionMultiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes. Voriconazole is extensively metabolized by the human hepatic enzymes, primarily mediated by CYP2C19. The polymorphisms account for a relatively large portion of inter-individual variance observed in voriconazole plasma concentrations. However, there are limited data on the relationships between voriconazole blood levels and clinical outcomes or safety in Asian populations. The purpose of this study is to investigate the relationships of voriconazole blood levels with genetic polymorphism, safety, and clinical outcomes in immunocompromised patients with invasive pulmonary aspergillosis.
Pharmacokinetics and Pharmacodynamics of Caspofungin (Cancidas ®) and Drug Tolerance of Fungi to...
Invasive Fungal InfectionTo investigate pharmacokinetics(PK) and pharmacodynamics(PD) of Caspofungin in ICU patients after received a loading dose of 70mg followed by 50mg (35mg if Child-Pugh score is 7-9), 40 patients will be recruited. Blood samplings for PK analysis will be collected on day 4 in this study. Caspofungin plasma concentrations are measured by using solid phase extraction and reverse phase high-performance liquid chromatography. Safety analyses will be taken daily during the treatment of Caspofungin. Tests for drug tolerance of fungi and efficacy assessment (clinical and mycological responses) will be taken every 3 days by clinical and mycological tests.
Hepatosplenic CANdidiasis : PETscan and Immune Response Analysis
Invasive Fungal DiseaseChronic Disseminated Candidiasis3 moreThe purpose of this study is to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.