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Completed

NCT Number: NCT02227797

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

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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Key information

Conditions

Fungal Infection Bacterial Infections and Mycoses Infections Mycoses

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Voriconazole

Drug

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

Primary outcomes

  1. Maximum tolerated, minimum efficacious dose for 3 different pediatric age groups

    Time frame: Seven days after starting voriconazole

Secondary outcomes

  1. Correlation of initial dose of voriconazole with voriconazole blood concentration in 3 different pediatric age groups

    Time frame: After starting voriconazole: Day 5, between Days 12-15, between Days 19-22

  2. Correlation of voriconazole dose with elevations to 5 times the upper limit of normal in liver enzymes

    Time frame: After starting voriconazole: Twice a week Days 1-30 and 1 week after the last dose of voriconazole ~ Day 35-42

  3. Incidence of fungal infection

    Time frame: 6-month period after transplant

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Aug 28, 2014
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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