Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients
- Conditions
- Invasive Fungal Infection
- Interventions
- Other: Use of different strategy for voriconazole dosage adjustment
- Registration Number
- NCT01185405
- Lead Sponsor
- Asan Medical Center
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Patients who received voriconazole
- Patients allergic to azole(s)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EA group Use of different strategy for voriconazole dosage adjustment Voriconazole dosage adjustment according to the each measurements of voriconazole levels from day 1, using NONMEM program CA group Use of different strategy for voriconazole dosage adjustment Voriconazole dosage adjustment according to the levels from day 5, using predefined protocol
- Primary Outcome Measures
Name Time Method Appropriateness of voriconazole trough level Day 3, day 5, day 10, and day 14
- Secondary Outcome Measures
Name Time Method Mortality 2 week, 4 week, 8 week, 12 week, and 24 week Voriconazole-related adverse event 1 week, 2 week
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of