"Personalizing Antifungal Therapy: Impact of CYP2C19 Genetic Variants on Voriconazole Pharmacokinetics in Indian Adults."
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- •Proportion of patients achieving therapeutic voriconazole trough concentrations across different CYP2C19 genotype categories (poor, intermediate, extensive, ultra-rapid metabolizers)
研究概览
简要总结
This study primarily aims to evaluate the association between CYP2C19 genetic polymorphisms and steady-state trough concentrations of voriconazole in Indian adult patients. Given voriconazole’s nonlinear pharmacokinetics and metabolism primarily via CYP2C19, genetic variations significantly influence drug exposure, potentially leading to subtherapeutic or toxic levels. By categorizing patients into metabolizer phenotypes (poor, intermediate, extensive, ultra-rapid) based on genotyping, the study seeks to determine how these variants affect plasma drug levels. Understanding this relationship will support genotype-guided dosing and enhance therapeutic precision, especially in immunocompromised patients where accurate drug exposure is critical for successful antifungal therapy.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients 18 years or above currently receiving voriconazole for 5 consecutive days for antifungal prophylaxis or treatment 2)Those willing to give written informed consent.
排除标准
- •Known poor compliance with voriconazole regimen.
- •If participated in other study in the past three months.
- •Participants on Phenytoin and Rifampicin will be excluded.
结局指标
主要结局
•Proportion of patients achieving therapeutic voriconazole trough concentrations across different CYP2C19 genotype categories (poor, intermediate, extensive, ultra-rapid metabolizers)
时间窗: Trough sample will be collected
次要结局
- 1)Proportion of patients having adverse events(2)To evaluate the predictive performance of the Bayesian dosing model by assessing the accuracy & precision of model-predicted voriconazole plasma concentrations as compared to observed concentrations.)
研究者
Gatadi K Sumedh
Nizams Institute of Medical Sciences