An observational study in Invasive Fungal Infection, sponsored by Asan Medical Center. Terminated at 1 site in Korea, Republic of. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2014-04-10.
Sponsored by Asan Medical Center · Observational
Multiple 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.
The investigators are trying to establish that routine clinical practice for voriconazole therapeutic drug monitoring can improve the efficacy and safety outcomes.
In Korean patients with hematologic malignancy, the investigators also want to propose the optimal dosing guideline of voriconazole with different genetic polymorphisms.
539 studies on the registry are indexed under Mycoses; 55 are open to participants now.
This study's enrollment of 10 is below the median of 152 across 150 observational studies indexed under Mycoses.
Browse Mycoses studies →Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with hematologic malignancies who were given voriconazole to treat invasive (pulmonary) aspergillosis at Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Inclusion Criteria: all items below
Exclusion Criteria:
Patients with hematologic malignancies who were given voriconazole to treat invasive (pulmonary) aspergillosis at Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Drug: voriconazole
intravenous, oral administration
Successful outcome at 12 weeks after voriconazole use
Successful outcome = complete response + partial response Unsuccessful outcome = stable disease + failure of therapy + indeterminate response
Time frame: 12 weeks
IFI (invasive fungal infection)-related mortality at 12 weeks
IFI (invasive fungal infection)-related mortality at 12 weeks
Time frame: 12 weeks
Successful outcomes at various time points
Successful outcomes at 1 week,2 weeks,4 weeks, and 8 weeks after voriconazole use
Time frame: 1 week, 2 weeks, 4 weeks, and 8 weeks
Non-IFI (invasive fungal infection)-related mortality at 12 weeks
Non-IFI (invasive fungal infection)-related mortality at 12 weeks
Time frame: 12 weeks
breakthrough IFI
breakthrough IFI
Time frame: 12 weeks
Adverse drug reactions
Adverse drug reactions (liver function test impairment, visual disturbance, hallucination, photosensitive rash, renal impairment)
Time frame: 12 weeks
This study is terminated, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.
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Asan Medical Center