MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients

University of Minnesota (UMN)

Status and phase

Completed

Phase 1

Conditions

Fungal Infection

Treatments

Drug: Voriconazole

Study type

Interventional

Funder types

Other

Identifiers

NCT02227797

2013LS126

MT2013-37R

Details and patient eligibility

About

The primary purpose of this study is to identify the optimal dose of voriconazole, an anti-fungal drug often used in people undergoing stem cell transplant. An optimal dose level is one level that provides a good blood level (concentration) of voriconazole without too much toxicity.

Enrollment

66 patients

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Any patient undergoing allogeneic hematopoietic stem cell transplantation (either 1st or subsequent)
Age ≤ 21 years
Adequate organ function within 14 days of enrollment, i.e. Creatinine: < 1.5 x ULN and Hepatic: ALT, AST and total bilirubin < 3 x ULN
Requires voriconazole to prevent or treat invasive fungal infection after undergoing stem cell transplantation

Exclusion criteria

Has received voriconazole within 5 days prior to starting study therapy
History of hypersensitivity or severe intolerance to azoles
History, or current evidence, of cardiac arrhythmias defined as QTc ≥ 480 mm/sec
Receiving the following drugs and cannot be discontinued at least 24 hours before starting therapy: pimozide, quinidine, astemizole, ergot alkaloids.
Received one or more of the following drugs within 14 days prior to starting study, as they are potent inducers of hepatic microsomal enzymes: rifampin, rifabutin, carbamazepine, phenytoin, nevirapine, long-acting barbiturates.
Received sirolimus within the 14 days prior to starting study as voriconazole is a potent inhibitor of sirolimus metabolism
Receiving or anticipated need for methadone as co-administration with voriconazole potentially increases methadone exposure