Therapeutic Drug Monitoring of Voriconazole

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-02-29

Brief Summary

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

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Detailed Description

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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.

Conditions

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Mycoses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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non-TDM of voriconazole

conventional dose

Group Type NO_INTERVENTION

No interventions assigned to this group

TDM of voriconazole

Group Type EXPERIMENTAL

Voriconazole (therapeutic drug monitoring)

Intervention Type DRUG

dosage adjustment according to trough level of voriconazole in plasma

Interventions

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Voriconazole (therapeutic drug monitoring)

dosage adjustment according to trough level of voriconazole in plasma

Intervention Type DRUG

Other Intervention Names

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plasma drug level

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No