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Therapeutic Drug Monitoring of Voriconazole

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Seoul National University

Status

Completed

Conditions

Mycoses

Treatments

Drug: Voriconazole (therapeutic drug monitoring)

Study type

Interventional

Funder types

Other

Identifiers

NCT00890708
H-0808-057-254

Details and patient eligibility

About

The purpose of this study is to determine whether therapeutic drug monitoring of voriconazole is useful in the treatment of invasive fungal infection.

Full description

Voriconazole is an anti-fungal agent, which is used in the treatment of invasive fungal infection, especially aspergillosis. The serious side effects of voriconazole include liver function abnormality, encephalopathy, etc. Recently, the several studies showed that the blood level of voriconazole is variable and it is associated with drug side effect and treatment outcome. However, there is no randomized controlled study which proves that therapeutic drug monitoring of voriconazole can improve the clinical outcome in routine clinical practice.

Enrollment

110 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients who were 16 years of age or older
  • receiving voriconazole in order to treat invasive fungal infections or for empirical use

Exclusion criteria

  • who experienced the serious side effect of voriconazole
  • were hypersensitive to azoles
  • had an aminotransferase, bilirubin, or alkaline phosphatase level higher than five times the upper limit of normal

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

110 participants in 2 patient groups

non-TDM of voriconazole
No Intervention group
Description:
conventional dose
TDM of voriconazole
Experimental group
Treatment:
Drug: Voriconazole (therapeutic drug monitoring)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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