This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Therapeutic Drug Monitoring of Voriconazole

This study has been completed.
Information provided by (Responsible Party):
Wan Beom Park, Seoul National University Hospital Identifier:
First received: April 29, 2009
Last updated: February 18, 2012
Last verified: February 2012
The purpose of this study is to determine whether therapeutic drug monitoring of voriconazole is useful in the treatment of invasive fungal infection.

Condition Intervention
Mycoses Drug: Voriconazole (therapeutic drug monitoring)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Influence of Therapeutic Drug Monitoring of Voriconazole on Incidence of Drug Adverse Reaction

Resource links provided by NLM:

Further study details as provided by Wan Beom Park, Seoul National University Hospital:

Primary Outcome Measures:
  • side effects [ Time Frame: during 3 months ]

Secondary Outcome Measures:
  • treatment response to voriconazole [ Time Frame: at 3 months ]
  • drug discontinuation of adverse events [ Time Frame: within 3 month ]

Enrollment: 110
Study Start Date: November 2008
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: non-TDM of voriconazole
conventional dose
Experimental: TDM of voriconazole Drug: Voriconazole (therapeutic drug monitoring)
dosage adjustment according to trough level of voriconazole in plasma
Other Name: plasma drug level

Detailed 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.

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00890708

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Wan Beom Park, MD, PhD Seoul National University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wan Beom Park, Assistant Professor, Seoul National University Hospital Identifier: NCT00890708     History of Changes
Other Study ID Numbers: H-0808-057-254
Study First Received: April 29, 2009
Last Updated: February 18, 2012

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors processed this record on June 23, 2017