Pharmacologic Optimization 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

PHASE3

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2017-01-31

Brief Summary

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The objective of this study proposal is to determine whether pharmacologic optimization of voriconazole by means of therapeutic drug monitoring (TDM) results in improved patient outcomes (efficacy and safety) and is more cost-effective compared to the current standard of care.

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Detailed Description

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Patients with haematological malignancies and chemotherapy-induced prolonged neutropenia are at risk for severe bacterial and fungal infections. These opportunistic infections can result in prolonged hospital stay, increases costs and greater mortality. Voriconazole has now been recommended as the first line agent for invasive pulmonary aspergillosis. Retrospective observational studies of voriconazole serum concentration suggest that serum concentration correlate with toxicity and clinical response. These observations were however made in small series of patients and data were collected retrospectively. These inherent methodological flaws make it impossible to draw definite conclusions about the effect of voriconazole serum level monitoring on the outcome of IA, and therefore considered insufficient proof to recommend voriconazole concentration determination in blood as standard of care. The impact that so called serum concentration guided dosing of voriconazole will have on treatment success can only be evaluated through a prospective randomized clinical trial.

For this purpose, we designed a prospective stratified cluster randomized cross-over trial of therapeutic drug monitoring in patients with haematological disease who have developed IA. The order of periods (TDM or standard of care, each 12 months) will be randomized per centre. During the TDM episode, the voriconazole dosage will be adjusted to achieve trough blood concentrations in a predefined window of 2-5 mg/L. A sample size of n=192 is needed to detect a 20% absolute reduction in the number of treatment failures (40% to 20 %) compared to control.

Conditions

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Invasive Fungal Infection Hematological Malignancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

Voriconazole dosing based on SPC

Group Type ACTIVE_COMPARATOR

voriconazole (dosing according to the SPC)

Intervention Type DRUG

No serum concentrations are determined

TDM

Voriconazole serum concentration based dosing

Group Type EXPERIMENTAL

voriconazole

Intervention Type DRUG

TDM (through level of 2-5mg/L).

Interventions

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voriconazole

TDM (through level of 2-5mg/L).

Intervention Type DRUG

voriconazole (dosing according to the SPC)

No serum concentrations are determined

Intervention Type DRUG

Other Intervention Names

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Vfend Vfend

Eligibility Criteria

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Inclusion Criteria

* are at least 18 years of age
* have received chemotherapy for haematological malignancies or have received a hematopoietic stem cell transplant
* proven, probable or possible invasive fungal disease according to the EORTC/MSG criteria
* treatment with voriconazole