Emergency Use of Voriconazole in Patients With Life-Threatening Invasive Fungal Infections
|First Received Date ICMJE||April 28, 2001|
|Last Updated Date||March 3, 2008|
|Start Date ICMJE||April 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00015665 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Emergency Use of Voriconazole in Patients With Life-Threatening Invasive Fungal Infections|
|Official Title ICMJE||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|
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.
The increase in the number of immunosuppressed patients as a result of more aggressive chemotherapy, transplantation, HIV infection has lead to an increase in the incidence of invasive fungal infections. Moreover, despite the availability of newer, less toxic preparations of Amphotericin B and azole antifungals such as fluconazole and itraconazole, invasive mycoses remain a therapeutic challenge.
Voriconazole is a new triazole that has shown in phase II studies to be very active against Aspergillus sp. Its side effect profile has been very benign, comparable with those of other FDA approved triazoles. In vitro studies also show that voriconazole has a very broad spectrum ranging from opportunistic to endemic fungi. In addition, the availability of intravenous and oral formulations add to its potential advantages because the therapy of these infections usually require long courses on antifungals.
In this study, voriconazole is used as a salvage therapy for those patients who are unable to tolerate or who have failed other antifungal therapies. Because of the abundance of immunocompromised patients at our center, we believe that having such a protocol ready for enrollment would mitigate delays in such crucial moments. We seek to enroll and treat 40 patients over a 3 year period.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Voriconazole|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||March 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
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
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00015665|
|Other Study ID Numbers ICMJE||010150, 01-I-0150|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2003|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP