CYP2C19 Genotype-Specific Dosing Plus TDM on Reaching Therapeutic Voriconazole Blood Levels

PHASE4CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

January 10, 2018

Primary Completion Date

August 31, 2019

Study Completion Date

August 28, 2020

Conditions
Aspergillosis InvasiveFungal Infection
Interventions
GENETIC

Voriconazole genotype-specific dosing

"Those in the intervention arm will receive an experimental dosage regimen of voriconazole based on their genetic status.~URM: 6 mg/kg voriconazole twice on the first day followed by 5 mg/kg twice daily, rounded to the nearest 50mg for oral formulations up to day 4 post-start of voriconazole therapy.~EM: 6 mg/kg voriconazole twice on the first day followed by 4 mg/kg twice daily, rounded to the nearest 50mg for oral formulations up to day 4 post-start of voriconazole therapy.~HEM and PM: 6 mg/kg voriconazole twice on the first day followed by 2 mg/kg twice daily, rounded to the nearest 50mg for oral formulations up to day 4 post-start of voriconazole therapy."

DRUG

Standard of Care

Participants are given 6 mg/kg voriconazole twice on the first day followed by 4 mg/kg twice daily, rounded to the nearest 50mg for oral formulations up to day 4 post-start of voriconazole therapy. After TDM is conducted on day 4 for all patients, dosing in both trial arms will adhere to the following in order to reach the target therapeutic window: 1.0-5.5 mg/L.

Trial Locations (2)

M5G 2C4

Toronto General Hospital, Toronto

M5G 2M9

Princess Margaret Cancer Care Centre, Toronto

All Listed Sponsors
lead

University Health Network, Toronto

OTHER

NCT03731169 - CYP2C19 Genotype-Specific Dosing Plus TDM on Reaching Therapeutic Voriconazole Blood Levels | Biotech Hunter | Biotech Hunter