Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients

Asan Medical Center

Status: Withdrawn

Conditions: Invasive Fungal Infection

Treatments: Other: Use of different strategy for voriconazole dosage adjustment

Study type: Interventional

Funder types: Other

Identifiers

NCT01185405

AVORI

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received voriconazole

Exclusion criteria

• Patients allergic to azole(s)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

EA group

Experimental group

Description:

Voriconazole dosage adjustment according to the each measurements of voriconazole levels from day 1, using NONMEM program

Treatment:

Other: Use of different strategy for voriconazole dosage adjustment

CA group

Active Comparator group

Description:

Voriconazole dosage adjustment according to the levels from day 5, using predefined protocol

Treatment:

Other: Use of different strategy for voriconazole dosage adjustment