Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients
Primary Purpose
Invasive Fungal Infection
Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Use of different strategy for voriconazole dosage adjustment
Sponsored by
About this trial
This is an interventional treatment trial for Invasive Fungal Infection focused on measuring Voriconazole, Therapeutic drug monitoring, Intensive care unit
Eligibility Criteria
Inclusion Criteria:
- Patients who received voriconazole
Exclusion Criteria:
- Patients allergic to azole(s)
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EA group
CA group
Arm Description
Voriconazole dosage adjustment according to the each measurements of voriconazole levels from day 1, using NONMEM program
Voriconazole dosage adjustment according to the levels from day 5, using predefined protocol
Outcomes
Primary Outcome Measures
Appropriateness of voriconazole trough level
Secondary Outcome Measures
Mortality
Voriconazole-related adverse event
Full Information
NCT ID
NCT01185405
First Posted
August 17, 2010
Last Updated
September 29, 2013
Sponsor
Asan Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01185405
Brief Title
Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients
Official Title
Prediction and Adjustment of Voriconazole Plasma Level in Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Withdrawn
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Voriconazole, a newer triazole-derivative, has become the drug of choice for many invasive fungal infections, including invasive Aspergillosis. Recently, therapeutic drug monitoring of voriconazole has been issued because of wide variations and unpredictability of voriconazole blood concentration. The objective of this study is 1) to characterize the pharmacokinetics of voriconazole in ICU patients on voriconazole prophylaxis or treatment, and 2) to develop and evaluate the prediction and adjustment models for voriconazole plasma levels.
Detailed Description
Patients will be randomly assigned into 2 groups: conventional adjustment group (CA group) and early adjustment group (EA group). Voriconazole plasma levels will be measured on day 1 (both peak and trough levels), day 3, day 5, day 10, and day 14 (all trough levels). For CA group patients, voriconazole dosage will be adjusted according to the trough levels of day 5 (steady-state level). Predefined dose adjustment protocol will be used (< 1 µg/ml: 50% increase, 1~5.5 µg/ml: no change, > 5.5 µg/ml: 50% decrease). For EA group patients, voriconazole dosage will be adjusted according to the each measurements of voriconazole levels from day 1. Adjusted dosage will be calculated using the NONMEN software. The target range of trough level is between 1.0 µg/ml and 5.5 µg/ml. The appropriateness of voriconazole level (day 5, day 10, and day 14), mortality, ICU stay, and the frequency of voriconazole-related adverse events will be compared. CYP2C19 polymorphism will be analyzed for all patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Fungal Infection
Keywords
Voriconazole, Therapeutic drug monitoring, Intensive care unit
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EA group
Arm Type
Experimental
Arm Description
Voriconazole dosage adjustment according to the each measurements of voriconazole levels from day 1, using NONMEM program
Arm Title
CA group
Arm Type
Active Comparator
Arm Description
Voriconazole dosage adjustment according to the levels from day 5, using predefined protocol
Intervention Type
Other
Intervention Name(s)
Use of different strategy for voriconazole dosage adjustment
Intervention Description
Patients will be randomly assigned into 2 groups: conventional adjustment group (CA group) and early adjustment group (EA group). Voriconazole plasma levels will be measured on day 1 (both peak and trough levels), day 3, day 5, day 10, and day 14 (all trough levels). For CA group patients, voriconazole dosage will be adjusted according to the trough levels of day 5 (steady-state level). Predefined dose adjustment protocol will be used (< 1 µg/ml: 50% increase, 1~5.5 µg/ml: no change, > 5.5 µg/ml: 50% decrease). For EA group patients, voriconazole dosage will be adjusted according to the each measurements of voriconazole levels from day 1. Adjusted dosage will be calculated using the NONMEN software.
Primary Outcome Measure Information:
Title
Appropriateness of voriconazole trough level
Time Frame
Day 3, day 5, day 10, and day 14
Secondary Outcome Measure Information:
Title
Mortality
Time Frame
2 week, 4 week, 8 week, 12 week, and 24 week
Title
Voriconazole-related adverse event
Time Frame
1 week, 2 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who received voriconazole
Exclusion Criteria:
Patients allergic to azole(s)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Ho Choi, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
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Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients
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