The Correlation of Voriconazole Trough Plasma Levels With Genetic Polymorphism, Efficacy, and Safety Outcomes in Hematologic Malignancy Patients With Invasive Pulmonary Aspergillosis
15 Years
N/A
Both
Invasive Fungal Infection
Trial Information
The Correlation of Voriconazole Trough Plasma Levels With Genetic Polymorphism, Efficacy, and Safety Outcomes in Hematologic Malignancy Patients With Invasive Pulmonary Aspergillosis
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.
Inclusion Criteria:
all items below- 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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Successful outcome at 12 weeks after voriconazole use
Outcome Description:
Successful outcome = complete response + partial response Unsuccessful outcome = stable disease + failure of therapy + indeterminate response
Outcome Time Frame:
12 weeks
Safety Issue:
No
Authority:
South Korea: Institutional Review Board
Study ID:
VCZ-IPA-HEM-2010
NCT ID:
NCT01148160
Start Date:
August 2010
Completion Date:
December 2012
Related Keywords:
- Invasive Fungal Infection
- voriconazole
- invasive pulmonary aspergillosis
- hematologic malignancy
- therapeutic drug monitoring
- genetic polymorphism
- efficacy
- safety
- Aspergillosis
- Neoplasms
- Mycoses
- Invasive Pulmonary Aspergillosis
- Hematologic Neoplasms
- Pulmonary Aspergillosis
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