Impact of Genotyping P450 2C19 on Hospitalization Period

Infection Clinical Trial

— PHARMACOGEN  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03554239
• Other study ID #: RC31/15/7853
• Status: Withdrawn
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Infection

Intervention

Genetic:
• genotyping
Blood sample

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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