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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Withdrawn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
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infection focused on measuring Genotyping techniques, Fungal infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 7, 2016
    Last Updated
    December 18, 2018
    Sponsor
    University Hospital, Toulouse
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    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    Withdrawn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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