Impact of Genotyping P450 2C19 on Hospitalization Period When Voriconazole Treatment is Started
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The length of stay hospitalization
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Voriconazole treatment
- •Man or woman
- •With social security number
排除标准
- •Patient or parent of patient who refuse to accept inform consent form
- •All patient under protection of adults
研究组 & 干预措施
Voriconazole treatment
Patients who start voriconazole treatment and receive benefits of genotyping
干预措施: genotyping (Genetic)
结局指标
主要结局
The length of stay hospitalization
时间窗: 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).
次要结局
未报告次要终点