Fungal Infection
Conditions
Keywords
stem cell transplant, hematopoietic stem cell transplant, fungal infection, voriconazole, pediatric
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 provides a good blood level (concentration) of voriconazole without too much toxicity.
Interventions
DRUGVoriconazole
6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups | Seven days after starting voriconazole |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of voriconazole dose with elevations to 5 times the upper limit of normal in liver enzymes | After starting voriconazole: Twice a week Days 1-30 and 1 week after the last dose of voriconazole ~ Day 35-42 |
| Incidence of fungal infection | 6-month period after transplant |
| Correlation of initial dose of voriconazole with voriconazole blood concentration in 3 different pediatric age groups | After starting voriconazole: Day 5, between Days 12-15, between Days 19-22 |
Countries
United States
Outcome results
None listed