To hear about similar clinical trials, please enter your email below
Trial Title:
Individualized First Maintenance Doses of Voriconazole Through a Multiparametric Algorithm
NCT ID:
NCT06582186
Condition:
Aspergillosis Invasive
Fungal Infection
Hematologic Malignancy
Conditions: Official terms:
Mycoses
Aspergillosis
Hematologic Neoplasms
Voriconazole
Conditions: Keywords:
model-informed precision dosing
single-arm prospective interventional study
Simon design
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Individualization of first voriconazole maintenance doses
Description:
Individualization of first voriconazole maintenance doses
Arm group label:
individualized maintenance doses
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 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.
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 aspergillosis. However, dose adjustments made as part of this
therapeutic drug monitoring only occur at the earliest 3 to 5 days after the initiation
of treatment, whereas it is essential to achieve effective concentrations from the start
of treatment. Simple a priori dose adjustment approaches based on CYP2C19 genotype have
been shown to improve voriconazole exposure and treatment response. However other factors
such as the patient's inflammatory status or age also influence voriconazole
exposure, suggesting that strategies for individualizing initial voriconazole doses could
be improved by integrating all covariates influencing voriconazole pharmacokinetics. In
this line, a previous multicenter and international study has developped and validated an
algorithm for calculating the first maintenance doses integrating not only the CYP2C19
genotype, but also the inflammatory status, the patient's age, and the presence (or
not) of hematological malignancy. Here, the investigators propose to evaluate the
interest of this multiparametric algorithm for improving initial exposure (within the
first 4 days) to voriconazole in patients suffering from haematological malignancies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gautier-Veyret
Address:
City:
Grenoble
Zip:
38043
Country:
France
Start date:
October 2024
Completion date:
October 2027
Lead sponsor:
Agency:
University Hospital, Grenoble
Agency class:
Other
Source:
University Hospital, Grenoble
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06582186
