NCT04238884

Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy

Randomized and Multicenter Clinical Trial to Evaluate the Effectiveness and Efficiency of a Voriconazole Preemptive Genotyping Strategy in Patients With Risk of Aspergillosis

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 146 (estimated)
• Sponsor: Instituto de Investigación Hospital Universitario La Paz · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a phase IV pragmatic, multicentre, randomised, simple-blind, parallel arm, centre-stratified clinical trial. The main objective is to compare efficiency of voriconazole preemptive genotyping strategy, compared with routine practice.

Detailed description

Primary outcome is serum level of voriconazole on fifth day. Secondary outcome is a combined variable of therapeutic failure and adverse events, associated with voriconazole. A total of 146 patients with risk of undergoing invasive aspergillosis who potentially will receive voriconazole will be recruited, and CYP2C19 will be genotyped. If the patient receives voriconazole finally, he will be randomized (1:1 experimental/control). In the experimental arm patients receive dose according to pharmacogenetic algorithm including CYP2C19 genotype and clinical and demographic information. In the control arm patients receive dose according to clinical practice guidelines. In addition, a Spain national health system (NHS) point-of-view cost-effectiveness evaluation is going to be done. Direct costs calculation of each arm will be done.

Conditions

• Invasive Fungal Infections

Interventions

Type	Name	Description
DRUG	Voriconazole preemptive genotyping strategy	The patients who finally receives voriconazole will be randomized to receive the dose according to a pharmacogenetic algorithm including CYP2C19 genotype and clinical and demographic information.
DRUG	Voriconazole clinical practice	The patients who finally receives voriconazole will be randomized to receive the dose according to clinical practice

Timeline

• Start date: 2020-01-02
• Primary completion: 2020-01-18
• Completion: 2022-12-31
• First posted: 2020-01-23
• Last updated: 2020-01-23

Locations

1 site across 1 country: Spain