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Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients

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ClinicalTrials.gov Identifier: NCT01185405
Recruitment Status : Withdrawn
First Posted : August 20, 2010
Last Update Posted : October 1, 2013
Sponsor:
Information provided by (Responsible Party):
Sang-Ho Choi, Asan Medical Center

August 17, 2010
August 20, 2010
October 1, 2013
August 2010
December 2013   (Final data collection date for primary outcome measure)
Appropriateness of voriconazole trough level [ Time Frame: Day 3, day 5, day 10, and day 14 ]
Same as current
Complete list of historical versions of study NCT01185405 on ClinicalTrials.gov Archive Site
  • Mortality [ Time Frame: 2 week, 4 week, 8 week, 12 week, and 24 week ]
  • Voriconazole-related adverse event [ Time Frame: 1 week, 2 week ]
Same as current
Not Provided
Not Provided
 
Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients
Prediction and Adjustment of Voriconazole Plasma Level in Critically Ill Patients
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.
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Invasive Fungal Infection
Other: Use of different strategy for voriconazole dosage adjustment
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.
  • Experimental: EA group
    Voriconazole dosage adjustment according to the each measurements of voriconazole levels from day 1, using NONMEM program
    Intervention: Other: Use of different strategy for voriconazole dosage adjustment
  • Active Comparator: CA group
    Voriconazole dosage adjustment according to the levels from day 5, using predefined protocol
    Intervention: Other: Use of different strategy for voriconazole dosage adjustment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
100
December 2013
December 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who received voriconazole

Exclusion Criteria:

  • Patients allergic to azole(s)
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01185405
AVORI
Yes
Not Provided
Not Provided
Sang-Ho Choi, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Sang-Ho Choi, MD Asan Medical Center
Asan Medical Center
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP