Impact of Genotyping P450 2C19 on Hospitalization Period

Study Overview
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Brief Summary
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Monocentric study with the objective to evaluate the impact of genotyping CYP2C19 on the hospitalization period. The genotyping will permit to adapt at best the Voriconazole posology.

Detailed Description
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The main objective of this multi-center study is to evaluate the impact of dose adjustment of Voriconazole after CYP2C19 genotyping at the start of treatment, on the length of hospital stay. Thus, a new strategy will be proposed as part of this project and will be compared to the reference strategy: The New strategy: genotyping of CYP2C19 in any patient receiving treatment with Voriconazole in order to better adapt the treatment regimen as quickly as possible (increase of the dosage of Voriconazole in high-speed metabolisers or use of another antifungal, decreased dosage in poor metabolisers). The Reference strategy: pharmacological therapeutic monitoring of Voriconazole allowing an adaptation of the Voriconazole dosage based on the residual concentration measured once steady state has been reached (5 elimination half-lives). Multicenter, randomized study comparing two strategies of Voriconazole adaptation according to whether or not genotyping of CYP2C19 is performed as soon as Voriconazole is started. Thus, the new strategy tested in this project and compared to the reference strategy (adaptation of Voriconazole dosage depending on the residual concentration), will be a genotyping of CYP2C19 in any patient receiving a treatment based on Voriconazole in order to better adapt the treatment regimen as quickly as possible (increase in the dosage of Voriconazole or use of another antifungal agent in ultra-rapid metabolisers, decrease in dosage in poor metabolisers).

Official Title
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Impact of Genotyping P450 2C19 on Hospitalization Period When Voriconazole Treatment is Started

Conditions
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Infection

Intervention / Treatment
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* Genetic: genotyping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Voriconazole treatment Man or woman With social security number Exclusion Criteria: Patient or parent of patient who refuse to accept inform consent form All patient under protection of adults
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Voriconazole treatment<br>Patients who start voriconazole treatment and receive benefits of genotyping | Genetic: genotyping<br>* Blood sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The length of stay hospitalization | This duration will be expressed in number of days and will be compared between patients who have been genotyped since the introduction of Voriconazole compared to patients who have received therapeutic monitoring of Voriconazole (reference strategy). | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genotyping techniques, Fungal infection