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Therapeutic Drug Monitoring of Voriconazole

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wan Beom Park, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00890708
First received: April 29, 2009
Last updated: February 18, 2012
Last verified: February 2012

April 29, 2009
February 18, 2012
November 2008
December 2011   (final data collection date for primary outcome measure)
side effects [ Time Frame: during 3 months ] [ Designated as safety issue: No ]
severe side effects [ Time Frame: during 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00890708 on ClinicalTrials.gov Archive Site
  • treatment response to voriconazole [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
  • drug discontinuation of adverse events [ Time Frame: within 3 month ] [ Designated as safety issue: No ]
treatment response to voriconazole [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00890708
H-0808-057-254
Yes
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