Emergency Use of Voriconazole in Patients With Life-Threatening Invasive Fungal Infections
Completed · Phase 3
Conditions studied: Mycoses
In brief
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.
Key facts
- Study ID
- NCT00015665
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 40
- Starts
- 2001-04-01
- Expected to finish
- 2003-03-01
- Last updated by the study team
- 2008-03-04
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All subjects must have a proven fungal infection that is resistant to standard therapy, or to which the patient is significantly intolerant. (Intolerance must include signs of intolerance such as fever, rigors, laboratory abnormalities, as well as subjective symptoms).
- Children are eligible.
You may not qualify if…
- AST, ALT greater than 10x the upper limit of normal
- Previous hypersensitivity to azole antifungals
- Concomitant Rifampin, carbamazepine, or barbiturates or greater than 3 days of such drugs in the 14 days prior to treatment with voriconazole
Where it is running
- National Institute of Allergy and Infectious Diseases (NIAID) — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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