Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients

NCT01185405 | Withdrawn DMC

• 1 other identifier: AVORI
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Fungal Infection

Keywords

Voriconazole; Therapeutic drug monitoring; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• Appropriateness of voriconazole trough level

  Day 3, day 5, day 10, and day 14

Secondary Outcomes (2)

• Mortality

  2 week, 4 week, 8 week, 12 week, and 24 week

• Voriconazole-related adverse event

  1 week, 2 week

Study Arms (2)

EA group

EXPERIMENTAL

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

Other: Use of different strategy for voriconazole dosage adjustment

CA group

ACTIVE COMPARATOR

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

Other: Use of different strategy for voriconazole dosage adjustment

Interventions

Use of different strategy for voriconazole dosage adjustment OTHER

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.

CA group; EA group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who received voriconazole

You may not qualify if:

• Patients allergic to azole(s)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Study Officials

• Sang-Ho Choi, MD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 17, 2010
• First Posted: August 20, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

KR (1)