Status:
COMPLETED
MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Fungal Infection
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
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 pro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02227797
Start Date
January 19 2015
End Date
March 1 2019
Last Update
April 29 2019
Active Locations (1)
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1
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, United States, 55455