Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2022-12-31

Brief Summary

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This is a phase IV pragmatic, multicentre, randomised, simple-blind, parallel arm, centre-stratified clinical trial. The main objective is to compare efficiency of voriconazole preemptive genotyping strategy, compared with routine practice.

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Detailed Description

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Primary outcome is serum level of voriconazole on fifth day. Secondary outcome is a combined variable of therapeutic failure and adverse events, associated with voriconazole. A total of 146 patients with risk of undergoing invasive aspergillosis who potentially will receive voriconazole will be recruited, and CYP2C19 will be genotyped. If the patient receives voriconazole finally, he will be randomized (1:1 experimental/control). In the experimental arm patients receive dose according to pharmacogenetic algorithm including CYP2C19 genotype and clinical and demographic information. In the control arm patients receive dose according to clinical practice guidelines. In addition, a Spain national health system (NHS) point-of-view cost-effectiveness evaluation is going to be done. Direct costs calculation of each arm will be done.

Conditions

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Invasive Fungal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group

Based on the genetic study carried out and the patient's characteristics (age, weight, indication), the Pharmacogenetics Unit of the University Hospital La Paz will indicate the dose to be administered based on the therapeutic individualization protocol guided by pharmacogenetics.

Group Type EXPERIMENTAL

Voriconazole preemptive genotyping strategy

Intervention Type DRUG

The patients who finally receives voriconazole will be randomized to receive the dose according to a pharmacogenetic algorithm including CYP2C19 genotype and clinical and demographic information.

Control group

No information will be provided and procedure will be carried out according to normal clinical practice, with clinical monitoring by the doctor in charge.

Group Type ACTIVE_COMPARATOR

Voriconazole clinical practice

Intervention Type DRUG

The patients who finally receives voriconazole will be randomized to receive the dose according to clinical practice

Interventions

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Voriconazole preemptive genotyping strategy

The patients who finally receives voriconazole will be randomized to receive the dose according to a pharmacogenetic algorithm including CYP2C19 genotype and clinical and demographic information.

Intervention Type DRUG

Voriconazole clinical practice

The patients who finally receives voriconazole will be randomized to receive the dose according to clinical practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patient at risk of developing invasive aspergillosis, that will potentially receive treatment or prophylaxis with voriconazole:

A. Pediatric population: children who are going to receive a transplant of hematopoietic precursors (HSCT) and acute myeloid leukemias, as well as relapses of it.

B. Adult population: patients diagnosed with acute leukemia, and those patients with expected prolonged neutropenia, secondary to hematological process and / or after specific treatment (aplastic anemia and variants, myelodysplastic syndrome, solid organ or bone marrow transplant, etc.), and those whose responsible clinician consider individually that they could present a risk of developing a fungal infection.
2. Those who agree to participate in the study by signing informed consent (patients equal or over 18 years old)
3. Subjects under 18 years old whose representative / legal guardian has voluntarily signed the informed consent.
4. In the case of mature under 18 years subjects (12-17 years of age), in addition to the consent signed by the legal guardian, the consent of the subject will be obtained.

Exclusion Criteria

1. Patients who for any reason should not be included in the study according to the criteria of the research team.
2. Subjects who are not capable to understand the information sheet and unable to sign the informed consent.

Eligible Sex

ALL

Accepts Healthy Volunteers

No