Impact of Genotyping P450 2C19 on Hospitalization Period (PHARMACOGEN)

December 18, 2018 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Voriconazole treatment
Patients who start voriconazole treatment and receive benefits of genotyping
Genetic: genotyping
Blood sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The length of stay hospitalization
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Peggy Gandia, PharmD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

June 13, 2018

Study Record Updates

Last Update Posted (Actual)

December 20, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/15/7853

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection

Clinical Trials on genotyping

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe