NCT00890708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

3.1 years

First QC Date

April 29, 2009

Last Update Submit

February 18, 2012

Conditions

Mycoses

Outcome Measures

Primary Outcomes (1)

  • side effects

    during 3 months

Secondary Outcomes (2)

  • treatment response to voriconazole

    at 3 months

  • drug discontinuation of adverse events

    within 3 month

Study Arms (2)

non-TDM of voriconazole

NO INTERVENTION

conventional dose

TDM of voriconazole

EXPERIMENTAL
Drug: Voriconazole (therapeutic drug monitoring)

Interventions

Voriconazole (therapeutic drug monitoring)DRUG

dosage adjustment according to trough level of voriconazole in plasma

Also known as: plasma drug level
TDM of voriconazole

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients who were 16 years of age or older
  • receiving voriconazole in order to treat invasive fungal infections or for empirical use

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 22761409DERIVED

MeSH Terms

Conditions

Mycoses

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Wan Beom Park, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 29, 2009

First Posted

April 30, 2009

Study Start

November 1, 2008

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

KR(1)