Therapeutic Drug Monitoring of Voriconazole

Mycoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00890708
• Other study ID #: H-0808-057-254
• Status: Completed
• Phase: N/A
• First received: April 29, 2009
• Last updated: February 18, 2012
• Start date: November 2008
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mycoses

Intervention

Drug:
• Voriconazole (therapeutic drug monitoring)
dosage adjustment according to trough level of voriconazole in plasma

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	side effects		during 3 months	No
Secondary	treatment response to voriconazole		at 3 months	No
Secondary	drug discontinuation of adverse events		within 3 month	No