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

Phase 1

Completed

• Conditions: Fungal Infection
• Interventions: Drug: Voriconazole

• Registration Number: NCT02227797
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-26
• Study First Submitted QC: 2014-08-26
• Study First Posted: 2014-08-28
• Study Start: 2015-01-19
• Primary Completion: 2017-09-08
• Study Completion: 2019-03-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-26
• Last Update Posted: 2019-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Voriconazole	Voriconazole	-

Primary Outcome Measures

Name	Time	Method
Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups	Seven days after starting voriconazole

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

University of Minnesota Medical Center, Fairview; 🇺🇸 Minneapolis, Minnesota, United States