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CompletedNCT00890708Updated Feb 22, 2012

Therapeutic Drug Monitoring of Voriconazole

An interventional study of Voriconazole (therapeutic drug monitoring) in Mycoses, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2012-02-22.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
16 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Mycoses

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03

In context

Mycoses

539 studies on the registry are indexed under Mycoses; 55 are open to participants now.

This study's enrollment of 110 is above the median of 46 across 358 interventional studies indexed under Mycoses.

Browse Mycoses studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,859 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
110 participants (actual)

Study arms

  • No intervention
    non-TDM of voriconazole

    conventional dose

  • Experimental
    TDM of voriconazole

    Drug: Voriconazole (therapeutic drug monitoring)

Interventions

  • DrugVoriconazole (therapeutic drug monitoring)

    dosage adjustment according to trough level of voriconazole in plasma

    Also known as: plasma drug level

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What researchers measure

Primary outcomes

  1. side effects

    Time frame: during 3 months

Secondary outcomes

  1. treatment response to voriconazole

    Time frame: at 3 months

  2. drug discontinuation of adverse events

    Time frame: within 3 month

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
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References and documents

Publications

  • 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. doi: 10.1093/cid/cis599. Epub 2012 Jul 3. PubMed 22761409 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00890708
Lead sponsor
Seoul National University Hospital
Responsible party
Wan Beom Park (Assistant Professor, Seoul National University Hospital) — Principal investigator
First posted
Apr 30, 2009
Start date
Nov 2008
Primary completion
Dec 2011
Completion
Feb 2012
Last update
Feb 22, 2012

Study contacts

Wan Beom Park, MD, PhD
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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