Emergency Use of Voriconazole in Patients With Life-Threatening Invasive Fungal Infections
Open-Label, Non-Comparative Protocol for the Emergency Use of Voriconazole in Patients With Life Threatening, Invasive Mycoses Who Are Failing on Currently Available Antifungal Agents
2 other identifiers
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2001
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedFirst Submitted
Initial submission to the registry
April 28, 2001
CompletedFirst Posted
Study publicly available on registry
April 30, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedMarch 4, 2008
March 1, 2003
April 28, 2001
March 3, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
April 28, 2001
First Posted
April 30, 2001
Study Start
April 1, 2001
Study Completion
March 1, 2003
Last Updated
March 4, 2008
Record last verified: 2003-03