Voriconazole Trough Plasma Levels : Genetic Polymorphism, Efficacy, Safety in Patients With Hematologic Malignancy

NCT ID: NCT01148160

Last Updated: 2014-04-10

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2014-04-30

Brief 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.

Detailed 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.

Conditions

Invasive Fungal Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Patients with hematologic malignancies who were given voriconazole to treat invasive (pulmonary) aspergillosis at Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

voriconazole

Intervention Type: DRUG

intravenous, oral administration

Interventions

voriconazole

intravenous, oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• male or female ≥ 15 years of age
• immunocompromised patients with hematologic disorders
• patients received voriconazole due to treat proven, probable invasive (pulmonary) aspergillosis

Exclusion Criteria

• severe hepatic dysfunction (t.bil, AST, ALT, ALP > 5 x upper normal limit)
• who experienced hypersensitivity to azoles
• pregnant women

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sung-Han Kim

Assistantant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center, University of Ulsan College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

VCZ-IPA-HEM-2010

Identifier Type: -

Identifier Source: org_study_id