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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-19

Study Completion Date

2019-03-01

Brief Summary

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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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Detailed Description

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Conditions

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Fungal Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Voriconazole

Group Type EXPERIMENTAL

Voriconazole

Intervention Type DRUG

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

Interventions

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Voriconazole

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

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No