NCT03554239

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 13, 2018

Completed
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

7 months

First QC Date

September 7, 2016

Last Update Submit

December 18, 2018

Conditions

Infection

Keywords

Genotyping techniquesFungal infection

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Voriconazole treatment

OTHER

Patients who start voriconazole treatment and receive benefits of genotyping

Genetic: genotyping

Interventions

genotypingGENETIC

Blood sample

Voriconazole treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with Voriconazole treatment
  • Man or woman
  • With social security number

You may not qualify if:

  • Patient or parent of patient who refuse to accept inform consent form
  • All patient under protection of adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

InfectionsMycoses

Interventions

Genotype

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Peggy Gandia, PharmD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2016

First Posted

June 13, 2018

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

December 1, 2017

Last Updated

December 20, 2018

Record last verified: 2018-12