PHARMACOGEN: Impact of Genotyping P450 2C19 on Hospitalization Period

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03554239

Collaborator

(none)

Enrollment

Arm

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infection	Genetic: genotyping	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Voriconazole treatment

Patients who start voriconazole treatment and receive benefits of genotyping

Genetic: genotyping

Blood sample

Outcome Measures

Primary Outcome Measures

The length of stay hospitalization [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Hospital, Toulouse

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Toulouse

ClinicalTrials.gov Identifier:

NCT03554239

Other Study ID Numbers:

RC31/15/7853

First Posted:

Jun 13, 2018

Last Update Posted:

Dec 20, 2018

Last Verified:

Dec 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Toulouse

Genotyping techniques

Fungal infection

Additional relevant MeSH terms:

Infections

Study Results

No Results Posted as of Dec 20, 2018