An observational study in Mycoses, Neutropenia and Bone Marrow Transplantation, sponsored by The Catholic University of Korea. Status unknown at 2 sites in Korea, Republic of. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2008-07-24.
Sponsored by The Catholic University of Korea · Observational
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.
539 studies on the registry are indexed under Mycoses; 55 are open to participants now.
This study's planned enrollment of 40 is below the median of 152 across 150 observational studies indexed under Mycoses.
Browse Mycoses studies →The Catholic University of Korea is the lead sponsor of 150 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
To regular setting of voriconazole TDM & establish relationship with efficacy and safety
Time frame: Prospective
To apply population pharmacokinetic-pharmacodynamic modeling and simulation technique on the clinical research of antifungal drugs.
Time frame: Prospective
This study is status unknown, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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The Catholic University of Korea