Randomized Clinical Trial to Evaluate the Use of Genotype-based Dosing of Voriconazole

What this Trial Is About

Researchers are evaluating voriconazole dosing for patients with fungal infections, aiming to improve treatment by using genotype testing and dose-forecasting software tailored to individual genetics. This Phase 2 randomized clinical trial compares precision dosing guided by CYP2C19 genotype and therapeutic drug monitoring (TDM) to the current standard weight-based dosing with adjustments based on clinical judgment. The study also examines feasibility, acceptability, and cost-effectiveness of implementing this genotype-based dosing approach in healthcare settings. Participants will be randomly assigned to either standard care or precision care groups. Both groups start voriconazole dosing with current standard methods, but the precision care group will have dose adjustments guided by TDM and genotype data using specialized dosing software on Days 5, 9, 15, and 22. Blood samples for TDM and genotype testing are collected at baseline and during treatment to inform dosing decisions. The study includes additional sub-studies assessing scalability, fidelity, and economic impact of this precision dosing method. Participants will have multiple blood draws for drug level monitoring and genotype testing, along with data collection on clinical outcomes and healthcare usage. Researchers will measure the proportion of patients reaching therapeutic voriconazole levels by Day 8 and assess treatment success, dose exposure, adverse events, and hospital stays up to 30 days. The trial involves regular evaluations to support dose adjustments and monitors the feasibility and acceptance of the precision dosing process over time, with participation lasting up to a month.

Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial