Status:
NOT_YET_RECRUITING
Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm
Lead Sponsor:
University Hospital, Grenoble
Conditions:
Aspergillosis Invasive
Fungal Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 vor...
Detailed Description
The currently recommended therapeutic drug monitoring of voriconazole has improved the efficacy of this treatment and reduced its adverse effects, especially for treatment and prophylaxis of invasive ...
Eligibility Criteria
Inclusion
- 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)
- having signed a written consent to participate
- affiliated to a social security system
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06582186
Start Date
October 1 2024
End Date
October 1 2027
Last Update
September 3 2024
Active Locations (1)
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1
Gautier-Veyret
Grenoble, France, 38043