Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015665
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-04-28
Brief Title:
Emergency Use of Voriconazole in Patients With Life-Threatening Invasive Fungal Infections
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2003-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-I-0150 | None | None | None |