Therapeutic Drug Monitoring of Voriconazole
- Conditions
- Mycoses
- Interventions
- Registration Number
- NCT00890708
- Lead Sponsor
- Seoul National University Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- patients who were 16 years of age or older
- receiving voriconazole in order to treat invasive fungal infections or for empirical use
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TDM of voriconazole Voriconazole (therapeutic drug monitoring) -
- Primary Outcome Measures
Name Time Method side effects during 3 months
- Secondary Outcome Measures
Name Time Method treatment response to voriconazole at 3 months drug discontinuation of adverse events within 3 month
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of