- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04238884
Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy (VORIGENPHARM)
Randomized and Multicenter Clinical Trial to Evaluate the Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy in Patients With Risk of Aspergillosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Madrid, Spain, 28046
- Recruiting
- La Paz University Hospital
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Contact:
- Alberto M Borobia, PI
- Phone Number: +34917277558
- Email: alberto.borobia@salud.madrid.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
- Those who agree to participate in the study by signing informed consent (patients equal or over 18 years old)
- Subjects under 18 years old whose representative / legal guardian has voluntarily signed the informed consent.
- 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:
- Patients who for any reason should not be included in the study according to the criteria of the research team.
- Subjects who are not capable to understand the information sheet and unable to sign the informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 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.
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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.
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ACTIVE_COMPARATOR: 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.
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The patients who finally receives voriconazole will be randomized to receive the dose according to clinical practice
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum voriconazole concentration
Time Frame: Day 5 of treatment
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Serum voriconazole concentration within the therapeutic range, in μg/mL.
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Day 5 of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Therapeutic failure
Time Frame: Within 3 months
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% of patients with therapeutic failure. A patient has a therapeutic failure if:
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Within 3 months
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Adverse event
Time Frame: Within 3 months
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% of patients with a dose-dependent drug adverse event reaction. It will be considered dose-dependent drug adverse reactions:
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Within 3 months
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Costs by adverse event
Time Frame: Day 90 of treatment
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Quantifying economic burden (in euros) associated with management of severe adverse events.
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Day 90 of treatment
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Quality adjusted life years (QALY)
Time Frame: Day 90 of treatment
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Measure of disease burden, including both the quality and the quantity of life lived.
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Day 90 of treatment
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Collaborators and Investigators
Investigators
- Principal Investigator: Alberto M Borobia, MD, PhD, La Paz University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections and Mycoses
- Mycoses
- Invasive Fungal Infections
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- 14-alpha Demethylase Inhibitors
- Voriconazole
Other Study ID Numbers
- 2019-000376-41
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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