Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001757
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
An Open Label Non-Comparative Multicenter Phase III Trial of the Efficacy Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Open Label Non-Comparative Multicenter Phase III Trial of the Efficacy Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections
Status:
COMPLETED
Status Verified Date:
1999-12
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:
Invasive fungal infections are often life-threatening in persons with immunocompromise Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at high risk for these infections Patients undergoing bone marrow transplantation receiving prolonged corticosteroid or other immunosuppressive therapies and persons with HIV infection and AIDS are also at risk With the use of currently approved antifungal therapy many of these infections may still be associated with a high mortality Amphotericin B in its conventional form is the current standard treatment for most life-threatening fungal infections Because of its nephrotoxicity and other adverse effects alternatives to conventional amphotericin B have been sought Alternated agents include three lipid formulations of amphotericin B fluconazole itraconazole Although all of these agents are associated with a decrease in adverse effects their efficacy in most life-threatening fungal infections has not been shown to be equivalent to conventional amphotericin B
Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US This azole has been shown active against many fungal pathogens in vitro In animal models and early human trials this new agent has been shown to be effective against aspergillosis It has been shown to be well-tolerated and is available in an intravenous and oral formulation
This is a non-comparative open label study to evaluate the efficacy safety and toleration of voriconazole in the treatment of invasive fungal infections This agent will be used as primary therapy in those fungal infections in which no antifungal agent is currently approved or in patients unable to tolerate the approved agent Voriconazole will also be used as a secondary treatment in those patients who have failed therapy with the primary approved agent or are unable to tolerate that agent or have unacceptable toxicity
Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US This azole has been shown active against many fungal pathogens in vitro In animal models and early human trials this new agent has been shown to be effective against aspergillosis It has been shown to be well-tolerated and is available in an intravenous and oral formulation
This is a non-comparative open label study to evaluate the efficacy safety and toleration of voriconazole in the treatment of invasive fungal infections This agent will be used as primary therapy in those fungal infections in which no antifungal agent is currently approved or in patients unable to tolerate the approved agent Voriconazole will also be used as a secondary treatment in those patients who have failed therapy with the primary approved agent or are unable to tolerate that agent or have unacceptable toxicity
Detailed Description:
Invasive fungal infections are often life-threatening in persons with immunocompromise Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at high risk for these infections Patients undergoing bone marrow transplantation receiving prolonged corticosteroid or other immunosuppressive therapies and persons with HIV infection and AIDS are also at risk With the use of currently approved antifungal therapy many of these infections may still be associated with a high mortality Amphotericin B in its conventional form is the current standard treatment for most life-threatening fungal infections Because of its nephrotoxicity and other adverse effects alternatives to conventional amphotericin B have been sought Alternate agents include three lipid formulations of amphotericin B fluconazole and itraconazole Although all of these agents are associated with a decrease in adverse effects their efficacy in most life-threatening fungal infections has not been shown to be equivalent to conventional amphotericin B
Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US This azole has been shown active against many fungal pathogens in vitro In animal models and early human trials this new agent has been shown to be effective against aspergillosis It has been shown to be well-tolerated and is available in an intravenous and oral formulation
This is a non-comparative open label study to evaluate the efficacy safety and toleration of voriconazole in the treatment of invasive fungal infections This agent will be used as primary therapy in those fungal infections in which no antifungal agent is currently approved or in patients unable to tolerate the approved agent Voriconazole will also be used as a secondary treatment in those patients who have failed therapy with the primary approved agent or are unable to tolerate that agent or have unacceptable toxicity
Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US This azole has been shown active against many fungal pathogens in vitro In animal models and early human trials this new agent has been shown to be effective against aspergillosis It has been shown to be well-tolerated and is available in an intravenous and oral formulation
This is a non-comparative open label study to evaluate the efficacy safety and toleration of voriconazole in the treatment of invasive fungal infections This agent will be used as primary therapy in those fungal infections in which no antifungal agent is currently approved or in patients unable to tolerate the approved agent Voriconazole will also be used as a secondary treatment in those patients who have failed therapy with the primary approved agent or are unable to tolerate that agent or have unacceptable toxicity
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 |
|---|---|---|---|
| 98-I-0028 | None | None | None |