MedTrace Logo

Voriconazole Pharmacokinetics in Children With Gastrointestinal Graft Versus Host Disease

NCT00792246 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2018-09-04

No results posted yet for this study

Summary

Determine how much voriconazole is absorbed when the product is given by mouth to children with extensive graft versus host disease after a stem cell transplantation and determine the correct dosing of voriconazole in this population.

Hypothesis: Children with gastrointestinal graft versus host disease will have decreased absorption of oral voriconazole and require higher doses of voriconazole in order to prevent or treat fungal infections.

Conditions

Interventions

DRUG

voriconazole

Voriconazole formulation will be changed from oral to intravenous at the same dose the subject is currently receiving per standard of care.

DRUG

voriconazole

Voriconazole formulation will be changed from oral to intravenous at the same dose the subject is currently receiving per standard of care.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Phillip Brian Smith

    lead OTHER

Principal Investigators

  • P Brian Smith, MD · Duke Unviersity Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00792246 on ClinicalTrials.gov