DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Therapeutic Drug Monitoring of Voriconazole

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mycoses

Intervention: Voriconazole (therapeutic drug monitoring) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Wan Beom Park, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital

Summary

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

Clinical Details

Official title: Influence of Therapeutic Drug Monitoring of Voriconazole on Incidence of Drug Adverse Reaction

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

Primary outcome: side effects

Secondary outcome:

treatment response to voriconazole

drug discontinuation of adverse events

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

Minimum age: 16 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Additional Information

Starting date: November 2008
Last updated: February 18, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017