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Therapeutic Drug Monitoring of Voriconazole

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00890708
First Posted: April 30, 2009
Last Update Posted: February 22, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wan Beom Park, Seoul National University Hospital
April 29, 2009
April 30, 2009
February 22, 2012
November 2008
December 2011   (Final data collection date for primary outcome measure)
side effects [ Time Frame: during 3 months ]
severe side effects [ Time Frame: during 3 months ]
Complete list of historical versions of study NCT00890708 on ClinicalTrials.gov Archive Site
  • treatment response to voriconazole [ Time Frame: at 3 months ]
  • drug discontinuation of adverse events [ Time Frame: within 3 month ]
treatment response to voriconazole [ Time Frame: at 3 months ]
Not Provided
Not Provided
 
Therapeutic Drug Monitoring of Voriconazole
Influence of Therapeutic Drug Monitoring of Voriconazole on Incidence of Drug Adverse Reaction
The purpose of this study is to determine whether therapeutic drug monitoring of voriconazole is useful in the treatment of invasive fungal infection.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Mycoses
Drug: Voriconazole (therapeutic drug monitoring)
dosage adjustment according to trough level of voriconazole in plasma
Other Name: plasma drug level
  • No Intervention: non-TDM of voriconazole
    conventional dose
  • Experimental: TDM of voriconazole
    Intervention: Drug: Voriconazole (therapeutic drug monitoring)
Park WB, Kim NH, Kim KH, Lee SH, Nam WS, Yoon SH, Song KH, Choe PG, Kim NJ, Jang IJ, Oh MD, Yu KS. The effect of therapeutic drug monitoring on safety and efficacy of voriconazole in invasive fungal infections: a randomized controlled trial. Clin Infect Dis. 2012 Oct;55(8):1080-7. Epub 2012 Jul 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
February 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00890708
H-0808-057-254
Yes
Not Provided
Not Provided
Wan Beom Park, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Wan Beom Park, MD, PhD Seoul National University Hospital
Seoul National University Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP