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Completed

NCT Number: NCT00890708

Therapeutic Drug Monitoring of Voriconazole

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

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Key information

Conditions

Mycoses Bacterial Infections and Mycoses Infections

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voriconazole (therapeutic drug monitoring)

Drug

dosage adjustment according to trough level of voriconazole in plasma

Other names: plasma drug level

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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Influence of Therapeutic Drug Monitoring of Voriconazole on Incidence of Drug Adverse Reaction

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Apr 30, 2009
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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