Therapeutic Drug Monitoring of Voriconazole
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Mycoses
Intervention: Voriconazole (therapeutic drug monitoring) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s): Wan Beom Park, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital
Summary
The purpose of this study is to determine whether therapeutic drug monitoring of
voriconazole is useful in the treatment of invasive fungal infection.
Clinical Details
Official title: Influence of Therapeutic Drug Monitoring of Voriconazole on Incidence of Drug Adverse Reaction
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: side effects
Secondary outcome: treatment response to voriconazoledrug discontinuation of adverse events
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Additional Information
Starting date: November 2008
Last updated: February 18, 2012
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