Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients

Status Withdrawn

Clinical Trial 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 Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01185405
Study type	Interventional
Source	Asan Medical Center
Contact
Status	Withdrawn
Phase	N/A
Start date	August 2010
Completion date	December 2013

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01888458` - Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD)	Phase 2
Completed	`NCT00412893` - Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis	Phase 3
Completed	`NCT03066011` - Registry of Patients Treated With Systemic Mold-Active Triazoles
Completed	`NCT04004078` - An Individualized Administration Research of Voriconazole Based on CYP2C19 Gene Polymorphism and TDM
Completed	`NCT01576653` - Prospective Clinical Evaluation of Beta-D-Glucan Assay in Blood and BAL	N/A
Enrolling by invitation	`NCT02510053` - Pharmacokinetics and Pharmacodynamics of Caspofungin (Cancidas ®) and Drug Tolerance of Fungi to Patients With an Invasive Fungal Infection in the Intensive Care Unit	N/A
Completed	`NCT01198236` - Efficacy of Itraconazole as Secondary Prophylaxis in Patients Undergoing Allogeneic Stem Cell Transplantation or Chemotherapy With Prior Invasive Fungal Infection	Phase 4
Recruiting	`NCT06137690` - Factors on Therapeutic Drug Monitoring and Safety of Voriconazole in Critically Ill Elderly Patients
Completed	`NCT01783379` - Pharmacokinetics of Micafungin in Patients Intensive Care Unit
Completed	`NCT01533558` - Pharmacokinetics of Caspofungin (Cancidas ®) Given Intravenously as Therapy to Patients With an Invasive Fungal Infection in the Intensive Care Unit - a Search for Co-variates
Recruiting	`NCT03149562` - Association of Plasma Transfusions and Invasive Fungal Infection
Recruiting	`NCT04665037` - Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)	Phase 2
Terminated	`NCT01148160` - Voriconazole Trough Plasma Levels : Genetic Polymorphism, Efficacy, Safety in Patients With Hematologic Malignancy	N/A
Completed	`NCT00893555` - Pharmacologic Optimization of Voriconazole	Phase 3
Unknown status	`NCT00460330` - Evaluate Three Methods for Diagnosis of Invasive Fungal Infection in Chinese Patients After HSCT	N/A
Completed	`NCT02823132` - Study of the Level of a Protein Which Could Predict the Development of a Fungal Infection in Patients With Acute Leukemia	N/A