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
  Purpose

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


Condition Intervention
Mycoses
Drug: Voriconazole (therapeutic drug monitoring)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Influence of Therapeutic Drug Monitoring of Voriconazole on Incidence of Drug Adverse Reaction

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • side effects [ Time Frame: during 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 110
Study Start Date: November 2008
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: plasma drug level

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890708

Locations
Korea, Republic of
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
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wan Beom Park, Assistant Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00890708     History of Changes
Other Study ID Numbers: H-0808-057-254
Study First Received: April 29, 2009
Last Updated: February 18, 2012
Health Authority: South Korea: Institutional Review Board

Additional relevant MeSH terms:
Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 26, 2014