Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy (VORIGENPHARM)
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|ClinicalTrials.gov Identifier: NCT04238884|
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Invasive Fungal Infections||Drug: Voriconazole preemptive genotyping strategy Drug: Voriconazole clinical practice||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized and Multicenter Clinical Trial to Evaluate the Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy in Patients With Risk of Aspergillosis|
|Actual Study Start Date :||January 2, 2020|
|Actual Primary Completion Date :||January 18, 2020|
|Estimated Study Completion Date :||December 31, 2022|
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.
Drug: 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.
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.
Drug: Voriconazole clinical practice
The patients who finally receives voriconazole will be randomized to receive the dose according to clinical practice
- Serum voriconazole concentration [ Time Frame: Day 5 of treatment ]Serum voriconazole concentration within the therapeutic range, in μg/mL.
- Therapeutic failure [ Time Frame: Within 3 months ]
% of patients with therapeutic failure. A patient has a therapeutic failure if:
- In patient with suspected or confirmed invasive aspergillosis: drug change or association, because of bad clinical or radiological evolution of the disease.
- In patient who receive prophylactic treatment: the necessity of change because of suspected or confirmed invasive fungal disease.
- Adverse event [ Time Frame: Within 3 months ]
% of patients with a dose-dependent drug adverse event reaction.
It will be considered dose-dependent drug adverse reactions:
- Visual disturbances (photopsias)
- Skin reactions
- Neurotoxicity (confusion and visual hallucinations) and
- Corrected QT interval (QTc) lengthening
- Costs by adverse event [ Time Frame: Day 90 of treatment ]Quantifying economic burden (in euros) associated with management of severe adverse events.
- Quality adjusted life years (QALY) [ Time Frame: Day 90 of treatment ]Measure of disease burden, including both the quality and the quantity of life lived.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238884
|Contact: Alberto M Borobia, MD, PhDfirstname.lastname@example.org|
|La Paz University Hospital||Recruiting|
|Madrid, Spain, 28046|
|Contact: Alberto M Borobia, PI +34917277558 email@example.com|
|Principal Investigator:||Alberto M Borobia, MD, PhD||La Paz University Hospital|