Status:
UNKNOWN
Influence of CYP2C19 Genotype on Safety and Efficacy of Voriconazole in Pediatric Patients With Hematologic Malignancy
Lead Sponsor:
Dokuz Eylul University
Collaborating Sponsors:
University of Liverpool
Conditions:
Adverse Drug Reactions
Eligibility:
All Genders
2-18 years
Brief Summary
Voriconazole is a drug used to treat invasive fungal infections. The amount of voriconazole in a person's blood helps to determine how effectively it treats an infection, and how safe it is. Patients ...
Detailed Description
Invasive fungal infections are the leading cause of mortality and morbidity in immune compromised children. Aspergillus species are reported to be the most common molds that cause invasive infections ...
Eligibility Criteria
Inclusion
- Aged between ≥2 years and \<18 years
- Receiving voriconazole for the treatment of an invasive fungal infection (IFI) and are within the first five days of the treatment course, OR are receiving voriconazole for the secondary prophylaxis against IFI during or after chemotherapy
- Agree to give one additional blood sample twice during the study for the purposes of pharmacogenetic analysis and determination of the serum trough voriconazole concentration, whilst their blood is being collected during normal clinical follow up without the requirement for any additional intravenous intervention
- Are willing and able to give informed consent and sign the informed consent form (by the patients and the parents OR the legal guardians)
Exclusion
- Have previously had CYP2C19 PGx testing performed
- Pregnant/breastfeeding
- Have cognitive impairment and/or psychiatric disorders and/or any other condition that will draw into question their capacity to provide informed consent
- Have severe hepatic insufficiency (Child-Pugh Class C) and have renal failure (estimated GFR \<15ml/min /1,73m2)
Key Trial Info
Start Date :
November 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2022
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04743544
Start Date
November 1 2019
End Date
October 31 2022
Last Update
February 8 2021
Active Locations (1)
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1
Dokuz Eylul University Hospital
Izmir, Turkey (Türkiye), 35330