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Therapeutic Drug Monitoring (TDM) of Voriconazole and Correlation With CYP2C19 Genotype in Korean Populations

NCT ID: NCT00673348

Last Updated: 2008-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-04-30

Brief Summary

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Voriconazole (VCZ), the antifungal drug active against Candida and Aspergillus is a substrate of CYP2C19, whose proportion of poor metabolizers is about \~20% in Asian population. The AUC's of VCZ differs over 4 folds by CYP2C19 genotypes of homozygotic wild type, heterozygote, and homozygotic poor metabolizers. The Asian population enrolled in the metabolism of VCZ were mainly Japanese and Chinese, without Korean subjects. The proportion of poor metabolizers in Korean population is known to be around 12% (Pharmacogenetics. 1996 Dec;6(6):547-51). The importance of CYP2C19 genotypes on the pharmacokinetics (PK) of voriconazole is well established, Hence, it is desirable to individualize the dosage regimen of VCZ according to the genotypes of patients. Fungal infection in immunocompromised patients is a life threatening condition which needs critical care. Although the PK change by genotypes are well known, its clinical implication or need for different dosage regimen by genotypes is not established, yet.

Detailed Description

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The investigators are trying to set up voriconazole (VCZ) therapeutic drug monitoring (TDM) \& establish relationship with efficacy and safety in Korea. The investigators also want to propose the optimal dosage regimen for VCZ over different genotypes of CYP2C19 in the immunocompromised patients in Korea.

Conditions

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Mycoses Neutropenia Bone Marrow Transplantation

Keywords

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Mycoses Voriconazole

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients suspected of invasive fungal infection (proven or probable cases) with immunocompromised state (for example, during neutropenia, receiving HSCT) in Catholic Hematopoietic Stem Cell Transplantation \[HSCT\] Center in Seoul, Korea.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Immunocompromised adults who are treated with voriconazole due to proven or probable invasive fungal infections

Exclusion Criteria

* Patients who have been treated with other investigational drugs
* Patients with liver dysfunction (aminotransferase level ≥ 5 times the upper limit of normal, bilirubin or alkaline phosphatase level \> 3 times the upper limit of normal)
* Patients with renal dysfunction (Cr level \> 2.5 times the upper limit of normal)
* Pregnant women
* Patients younger than 15 years of age
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Division of Infectious Diseases, Department of Internal Medicine

Principal Investigators

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Dong-Gun Lee, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

St. Mary's Hospital, The Catholic Univ. of Korea

Locations

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St. Mary's Hospital

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

St. Mary's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dong-Gun Lee, M.D., Ph.D.

Role: CONTACT

Phone: 82-2-3779-1114

Email: [email protected]

Dong-Seok Yim, M.D., Ph.D.

Role: CONTACT

Phone: 82-2-590-1114

Email: [email protected]

Facility Contacts

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Dong-Gun Lee, M.D., Ph.D.

Role: primary

Hae-Young Youn, Pharm D

Role: primary

References

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Kim SH, Yim DS, Choi SM, Kwon JC, Han S, Lee DG, Park C, Kwon EY, Park SH, Choi JH, Yoo JH. Voriconazole-related severe adverse events: clinical application of therapeutic drug monitoring in Korean patients. Int J Infect Dis. 2011 Nov;15(11):e753-8. doi: 10.1016/j.ijid.2011.06.004. Epub 2011 Aug 9.

Reference Type DERIVED
PMID: 21831685 (View on PubMed)

Other Identifiers

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VCZ_TDM_Korea

Identifier Type: -

Identifier Source: org_study_id