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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| To regular setting of voriconazole TDM & establish relationship with efficacy and safety | Prospective |
| Measure | Description | Time Frame |
|---|---|---|
| To apply population pharmacokinetic-pharmacodynamic modeling and simulation technique on the clinical research of antifungal drugs. | Prospective |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong-Gun Lee, M.D., Ph.D. | Contact | 82-2-3779-1114 | 1099 | symonlee@catholic.ac.kr |
| Dong-Seok Yim, M.D., Ph.D. | Contact | 82-2-590-1114 | 1201 | yimds@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Dong-Gun Lee, M.D., Ph.D. | St. Mary's Hospital, The Catholic Univ. of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Mary's Hospital | Not yet recruiting | Seoul | 150-713 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21831685 | Derived | 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. |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
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| St. Mary's Hospital | Recruiting | Seoul | 150-713 | South Korea |
|
| D000095542 |
| Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |