Emergency Use of Voriconazole in Patients With Life-Threatening Invasive Fungal Infections
Status:
Completed
Trial end date:
2003-03-01
Target enrollment:
Participant gender:
Summary
This protocol provides for emergency treatment with the experimental anti-fungal drug
voriconazole for patients with life-threatening invasive fungal infections. The increase in
the number of patients whose immune function is suppressed because of chemotherapy, tissue or
organ transplantation, or HIV infection has led to an increase in fungal infections. New
drugs are needed to combat these infections in patients who do not respond to or cannot
tolerate standard treatments.
Patients on other primary NIH protocols who have an invasive life-threatening fungal
infection that does not respond to currently available treatments or who cannot tolerate
these treatments may be eligible for this study.
Participants will have a blood test and a physical examination before receiving voriconazole.
They will receive voriconazole twice a day either as an infusion into a vein or as tablets
taken by mouth. Adult patients will be asked to provide a blood sample any time after the
first dose of voriconazole to be used for developing a test to measure voriconazole
concentration in the blood. Patients will be evaluated about 10 days after starting treatment
and then at least once every 4 weeks with a symptom check and blood test.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)