Back to resultsTherapeutic Drug Monitoring of Voriconazole
Primary Purpose
Mycoses
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Voriconazole (therapeutic drug monitoring)
Sponsored by
About this trial
This is an interventional treatment trial for Mycoses
Eligibility 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
non-TDM of voriconazole
TDM of voriconazole
Arm Description
conventional dose
Outcomes
Primary Outcome Measures
side effects
Secondary Outcome Measures
treatment response to voriconazole
drug discontinuation of adverse events
Full Information
NCT ID
NCT00890708
First Posted
April 29, 2009
Last Updated
February 18, 2012
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00890708
Brief Title
Therapeutic Drug Monitoring of Voriconazole
Official Title
Influence of Therapeutic Drug Monitoring of Voriconazole on Incidence of Drug Adverse Reaction
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
non-TDM of voriconazole
Arm Type
No Intervention
Arm Description
conventional dose
Arm Title
TDM of voriconazole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Voriconazole (therapeutic drug monitoring)
Other Intervention Name(s)
plasma drug level
Intervention Description
dosage adjustment according to trough level of voriconazole in plasma
Primary Outcome Measure Information:
Title
side effects
Time Frame
during 3 months
Secondary Outcome Measure Information:
Title
treatment response to voriconazole
Time Frame
at 3 months
Title
drug discontinuation of adverse events
Time Frame
within 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan Beom Park, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22761409
Citation
Park WB, Kim NH, Kim KH, Lee SH, Nam WS, Yoon SH, Song KH, Choe PG, Kim NJ, Jang IJ, Oh MD, Yu KS. The effect of therapeutic drug monitoring on safety and efficacy of voriconazole in invasive fungal infections: a randomized controlled trial. Clin Infect Dis. 2012 Oct;55(8):1080-7. doi: 10.1093/cid/cis599. Epub 2012 Jul 3.
Results Reference
derived
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Therapeutic Drug Monitoring of Voriconazole
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