Status:
COMPLETED
Voriconazole Pharmacokinetics in Children With Gastrointestinal Graft Versus Host Disease
Lead Sponsor:
Phillip Brian Smith
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Graft Versus Host Disease
Stem Cell Transplantation
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
Brief 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 o...
Detailed Description
Disseminated fungal infections are a leading cause of mortality in children who receive hematopoietic stem cell transplantation (SCT). Therefore, children routinely receive prophylactic and empirical ...
Eligibility Criteria
Inclusion
- Age ≤ 18 years, sufficient venous access to permit administration of voriconazole, ability to take oral medications, written informed consent provided by the parent or legally authorized representative, and Grade II or higher (extensive) gastrointestinal graft versus host disease for those patients in the graft versus host disease patient subset.
Exclusion
- History of anaphylaxis attributed to voriconazole or other triazole compounds, any concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study, or previous participation in this study.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00792246
Start Date
December 1 2008
End Date
July 1 2012
Last Update
September 4 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Medical Center
Durham, North Carolina, United States, 27710