Clinical Trials Logo

Clinical Trial Summary

Multiple factors are associated with a large variability in voriconazole exposure following standard dose administration, such as non-linear saturable pharmacokinetics, drug-drug interactions, liver disease, patient age, and genetic polymorphism of the metabolic enzymes.

Voriconazole is extensively metabolized by the human hepatic enzymes, primarily mediated by CYP2C19. The polymorphisms account for a relatively large portion of inter-individual variance observed in voriconazole plasma concentrations.

However, there are limited data on the relationships between voriconazole blood levels and clinical outcomes or safety in Asian populations.

The purpose of this study is to investigate the relationships of voriconazole blood levels with genetic polymorphism, safety, and clinical outcomes in immunocompromised patients with invasive pulmonary aspergillosis.


Clinical Trial Description

The investigators are trying to establish that routine clinical practice for voriconazole therapeutic drug monitoring can improve the efficacy and safety outcomes.

In Korean patients with hematologic malignancy, the investigators also want to propose the optimal dosing guideline of voriconazole with different genetic polymorphisms. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT01148160
Study type Observational
Source Asan Medical Center
Contact
Status Terminated
Phase N/A
Start date August 2010
Completion date April 2014

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
Withdrawn NCT01185405 - Voriconazole Plasma Level in Intensive Care Unit (ICU) Patients 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