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| ID | Type | Description | Link |
|---|---|---|---|
| MT2013-37R |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Voriconazole | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Voriconazole | Drug | 6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups | Seven days after starting voriconazole |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Correlation of voriconazole dose with elevations to 5 times the upper limit of normal in liver enzymes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Smith, M.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Pui-Yang Iroh Tam, M.D. | Masonic Cancer Center, Univeristy of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34970774 | Derived | Takahashi T, Jaber MM, Smith AR, Jacobson PA, Fisher J, Kirstein MN. Predictive Value of C-Reactive Protein and Albumin for Temporal Within-Individual Pharmacokinetic Variability of Voriconazole in Pediatric Patients Undergoing Hematopoietic Cell Transplantation. J Clin Pharmacol. 2022 Jul;62(7):855-862. doi: 10.1002/jcph.2024. Epub 2022 Feb 19. |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D065819 | Voriconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| 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 |