Mycoses
Conditions
Brief summary
The purpose of this study is to determine whether therapeutic drug monitoring of voriconazole is useful in the treatment of invasive fungal infection.
Detailed description
Voriconazole is an anti-fungal agent, which is used in the treatment of invasive fungal infection, especially aspergillosis. The serious side effects of voriconazole include liver function abnormality, encephalopathy, etc. Recently, the several studies showed that the blood level of voriconazole is variable and it is associated with drug side effect and treatment outcome. However, there is no randomized controlled study which proves that therapeutic drug monitoring of voriconazole can improve the clinical outcome in routine clinical practice.
Interventions
DRUGVoriconazole (therapeutic drug monitoring)
dosage adjustment according to trough level of voriconazole in plasma
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients who were 16 years of age or older * receiving voriconazole in order to treat invasive fungal infections or for empirical use
Exclusion criteria
* who experienced the serious side effect of voriconazole * were hypersensitive to azoles * had an aminotransferase, bilirubin, or alkaline phosphatase level higher than five times the upper limit of normal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| side effects | during 3 months |
Secondary
| Measure | Time frame |
|---|---|
| treatment response to voriconazole | at 3 months |
| drug discontinuation of adverse events | within 3 month |
Countries
South Korea
Outcome results
None listed