Research

Respiratory Fungal Infection Treatment with Voriconazole – Phase III

Voriconazole as Therapy for Treatment of Invasive Aspergillosis and Molds

Protocol Description

The purpose of this multi-center international study is to determine the safety profile and effects of voriconazole to treat different kinds of serious fungal infections in children. Researchers are investigating voriconazole as primary therapy for treatment of invasive aspergillosis and molds such as scedosporium or fusarium species in pediatric patients.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to patients of both genders, ages 2 through 17, who have been diagnosed with proven, probable or possible invasive aspergillosis or a rare mold infection.
Boys: Ages 2 through 17
Girls: Ages 2 through 17

Requirements
Participants will be enrolled in the study for 6 to 12 weeks. For at least the first 7 days of the study, participants will receive intravenous (IV) does of voriconazole every 12 hours in the hospital. With significant clinical improvement, participants will be switched to an oral regimen that may be able to be taken at home.
Visits: Requires hospitalization for initial IV therapy, and weekly visits thereafter
Duration: Up to 12 weeks

Status: Open for Enrollment

Source(s) of Support
Pfizer

Additional Information
Study description at National Institutes of Health