Published July 11, 2026 | Version Final version
Dataset Restricted

Pre-emptive CYP2C19 genotyping and voriconazole exposure in pediatric hematology patients at risk of aspergillosis: an exploratory randomized pilot study with a cost-consequence analysis

Authors/Creators

  • 1. ROR icon Hospital Universitario La Paz
  • 2. ROR icon Universidad de Alcalá
  • 3. ROR icon Hospital Central de la Defensa Gómez Ulla
  • 4. Universidad Francisco de Vitoria Facultad de Ciencias de la Salud
  • 5. ROR icon Universidad de Granada
  • 6. Instituto de Investigación Biosanitaria de Granada
  • 7. Universidad Autónoma de Madrid Facultad de Medicina
  • 8. ROR icon Hospital Universitario de La Princesa
  • 9. School of Medicine. Universidad Autónoma de Madrid
  • 10. ROR icon Universidad Autónoma de Madrid

Description

This is the dataset of a pragmatic, randomized, single-blind trial (EudraCT: 2019-000376-41; ClinicalTrials.gov: NCT04238884), including pediatric hematology patients at high risk of aspergillosis. The patients were randomized (1:1) to receive either standard weight-based dosing (Control) or preemptive CYP2C19 (*1, *2, *3, *17 alleles) genotype-guided dosing (Experimental). The primary endpoint was the proportion of patients achieving a therapeutic voriconazole trough concentration (Cmin: 1.0–5.0 mg/L) at Day 5 (±1). The analysis was conducted using a modified intention-to-treat approach. 

Files

Restricted

The record is publicly accessible, but files are restricted. <a href="https://zenodo.org/account/settings/login?next=https://zenodo.org/records/21306941">Log in</a> to check if you have access.

Additional details

Funding

Instituto de Salud Carlos III
PI18/01322