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

Fungal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227797
• Other study ID #: 2013LS126
• Secondary ID: MT2013-37R
• Status: Completed
• Phase: Phase 1
• Start date: January 19, 2015
• Est. completion date: March 1, 2019

Study information

• Verified date: April 2019
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 1, 2019
• Est. primary completion date: September 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses

Intervention

Drug:
• Voriconazole
6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups		Seven days after starting voriconazole
Secondary	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
Secondary	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
Secondary	Incidence of fungal infection		6-month period after transplant