Therapeutic Drug Monitoring of Voriconazole | NCT00890708

Studies
Therapeutic Drug Monitoring of Voriconazole

NCT00890708

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Feb 22, 2012Estimated

Enrollment

110Actual

Phase

Not Applicable

Conditions

Mycoses

Interventions

Voriconazole (therapeutic drug monitoring)

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Dec 2011Actual

Completion Date

Feb 2012Actual

First Submitted Date

Apr 29, 2009

First Submission Date that Met QC Criteria

Apr 29, 2009

First Posted Date

Apr 30, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2012

Last Update Posted Date

Feb 22, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Wan Beom Park, Assistant Professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
non-TDM of voriconazole	No Intervention	conventional dose
TDM of voriconazole	Experimental		Drug: Voriconazole (therapeutic drug monitoring)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Voriconazole (therapeutic drug monitoring)	Drug	dosage adjustment according to trough level of voriconazole in plasma	TDM of voriconazole

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
side effects		during 3 months

Secondary Outcomes

Measure	Description	Time Frame
treatment response to voriconazole		at 3 months
drug discontinuation of adverse events		within 3 month

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wan Beom Park, MD, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		110-744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22761409	Derived	Park WB, Kim NH, Kim KH, Lee SH, Nam WS, Yoon SH, Song KH, Choe PG, Kim NJ, Jang IJ, Oh MD, Yu KS. The effect of therapeutic drug monitoring on safety and efficacy of voriconazole in invasive fungal infections: a randomized controlled trial. Clin Infect Dis. 2012 Oct;55(8):1080-7. doi: 10.1093/cid/cis599. Epub 2012 Jul 3.

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds