Impact of Genotyping P450 2C19 on Hospitalization Period (PHARMACOGEN)
Primary Purpose
Infection
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
genotyping
Sponsored by
About this trial
This is an interventional diagnostic trial for Infection focused on measuring Genotyping techniques, Fungal infection
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Voriconazole treatment
Arm Description
Patients who start voriconazole treatment and receive benefits of genotyping
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03554239
First Posted
September 7, 2016
Last Updated
December 18, 2018
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03554239
Brief Title
Impact of Genotyping P450 2C19 on Hospitalization Period
Acronym
PHARMACOGEN
Official Title
Impact of Genotyping P450 2C19 on Hospitalization Period When Voriconazole Treatment is Started
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Study Start Date
December 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
Genotyping techniques, Fungal infection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Voriconazole treatment
Arm Type
Other
Arm Description
Patients who start voriconazole treatment and receive benefits of genotyping
Intervention Type
Genetic
Intervention Name(s)
genotyping
Intervention Description
Blood sample
Primary Outcome Measure Information:
Title
The length of stay hospitalization
Description
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).
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peggy Gandia, PharmD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Impact of Genotyping P450 2C19 on Hospitalization Period
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