MT2013-37R: Voriconazole Monitoring in Pediatric Stem Cell Transplant Patients
Completed · Phase 1
Conditions studied: Fungal Infection
In brief
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.
Key facts
- Study ID
- NCT02227797
- Run by
- Masonic Cancer Center, University of Minnesota
- People needed
- 66
- Starts
- 2015-01-19
- Expected to finish
- 2019-03-01
- Last updated by the study team
- 2019-04-29
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Minnesota Medical Center, Fairview — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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