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Therapeutic Drug Monitoring of Voriconazole

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00890708
Collaborator
(none)
110
Enrollment
1
Location
2
Arms
39
Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Voriconazole (therapeutic drug monitoring)
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Influence of Therapeutic Drug Monitoring of Voriconazole on Incidence of Drug Adverse Reaction
Study Start Date :
Nov 1, 2008
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Feb 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • plasma drug level

    		•

    Outcome Measures

    Primary Outcome Measures

    1. side effects [during 3 months]

    Secondary Outcome Measures

    1. treatment response to voriconazole [at 3 months]

    2. drug discontinuation of adverse events [within 3 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    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

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of 110-744

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Wan Beom Park, MD, PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wan Beom Park, Assistant Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT00890708
    Other Study ID Numbers:
    • H-0808-057-254
    First Posted:
    Apr 30, 2009
    Last Update Posted:
    Feb 22, 2012
    Last Verified:
    Feb 1, 2012
    Additional relevant MeSH terms:
    Mycoses
    Voriconazole

    Study Results

    No Results Posted as of Feb 22, 2012