Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients
Information source: Asan Medical Center
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Invasive Fungal Infection
Intervention: Use of different strategy for voriconazole dosage adjustment (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Asan Medical Center Official(s) and/or principal investigator(s):
Sang-Ho Choi, MD, Principal Investigator, Affiliation: Asan Medical Center
Overall contact:
Sang-Ho Choi, MD, Phone: 82-2-3010-3304, Email: sangho@amc.seoul.kr
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.
Clinical Details
Official title: Prediction and Adjustment of Voriconazole Plasma Level in Critically Ill Patients
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Appropriateness of voriconazole trough level
Secondary outcome: MortalityVoriconazole-related adverse event
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who received voriconazole
Exclusion Criteria:
- Patients allergic to azole(s)
Locations and Contacts
Sang-Ho Choi, MD, Phone: 82-2-3010-3304, Email: sangho@amc.seoul.kr
Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting
Sang-Ho Choi, MD, Phone: 82-2-3010-3304, Email: sangho@amc.seoul.kr
Additional Information
Starting date: August 2010
Last updated: June 11, 2012
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