ClinicalTrials.gov
ClinicalTrials.gov Menu

Therapeutic Drug Monitoring of Voriconazole

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00890708
Recruitment Status : Completed
First Posted : April 30, 2009
Last Update Posted : February 22, 2012
Sponsor:
Information provided by (Responsible Party):
Wan Beom Park, Seoul National University Hospital

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
Mycoses Drug: Voriconazole (therapeutic drug monitoring) Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : November 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine


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 Name: plasma drug level




Primary Outcome Measures :
  1. side effects [ Time Frame: during 3 months ]

Secondary Outcome Measures :
  1. treatment response to voriconazole [ Time Frame: at 3 months ]
  2. drug discontinuation of adverse events [ Time Frame: within 3 month ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 30, 2009    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Mycoses
Voriconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors