Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Grenoble
About this trial
The goal of this interventional single-arm study is to evaluate the interest of a multiparametric algorithm for individualization of first voriconazole maintenance doses for improvement of initial voriconazole exposure in adult patients with haematological malignancies. The main objective it aims is to determine the percentage of patients with initial voriconazole trough concentrations in the therapeutic range after individualization of first maintenance doses.
Participants will benefited from individualization of first voriconazole maintenance doses through a previously developed and validated multiparametric algorithm (publication in progress) taking into account CYP2C19 genotype, C reactive protein level and age.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patient suffering from haematological malignancy
followed in the clinical hematology department or in the hematology day hospital of the Grenoble Alps University Hospital
consenting to carrying out CYP2C19 genotyping
likely to start treatment with voriconazole (for curative or prophylactic purposes as part of care)
Disqualifiers
comedication with strong inhibitors/inducers (valproic acid, phenytoin, carbamazepine, rifampicin)
Subject during exclusion period from another study,
Persons referred to in articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman, parturient woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, persons subject to care psychiatric pursuant to articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of article L. 1121-8, persons admitted to a health or social establishment for purposes other than research , minors, person subject to a legal protection measure or unable to express their consent)
Trial design
Design model
Single group
Treatments tested in this trial
Individualization of first voriconazole maintenance doses
DrugIndividualization of first voriconazole maintenance doses
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: individualized maintenance dosesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients with initial plasma voriconazole trough concentration in the therapeutic range
Time frame
Day 5 +/-2Secondary outcomes
1
Frequency of initial plasma voriconazole trough concentrations above the therapeutic range
Time frame
Day 5 +/-22
Frequency of initial plasma voriconazole trough concentrations below the therapeutic range
Time frame
Day 5 +/-23
Voriconazole area under the curve (AUC0-12h) after the first maintenance dose individualized
Time frame
Day 24
Time to get the therapeutic range
Time frame
through study completion, an average of 3 monthsSponsors and contacts
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Source ClinicalTrials.gov
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