Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001646
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Voriconazole vs Amphotericin B in the Treatment of Invasive Aspergillosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Voriconazole vs Amphotericin B in the Treatment of Invasive Aspergillosis
Status:
COMPLETED
Status Verified Date:
1999-09
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 aspergillosis is a fungal disease which is increasing in incidence with the increase in immunocompromised persons in our population Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at the highest risk for acute aspergillosis Patients undergoing bone marrow transplantation receiving prolonged corticosteroid or other immunosuppressive therapies and persons with HIV infection and AIDS are also at risk Even with antifungal therapy aspergillosis in its acute invasive forms has a high mortality In bone marrow transplantation patients and in those whose infection involves the brain this mortality is greater than 90 Amphotericin B in its conventional form is the current standard treatment for this disease Response to therapy with amphotericin B usually ranges between 20-60 in most studies The higher response rates are usually seen in those patients who can tolerate this agent for at least 14 days Because of its nephrotoxicity and other adverse effects alternatives to conventional amphotericin B have been sought These currently include liposomal forms of amphotericin B and itraconazole Although these forms show a decrease in adverse effects the efficacy of these drugs 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 Aspergillus spp in vitro and in animal models and early human trials to be effective against aspergillosis It has been shown to be well-tolerated and is available in an intravenous and oral formulation
This study will evaluate the efficacy safety and toleration of voriconazole compared to conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis in immunocompromised patients Patients will be randomized to open-labelled therapy with voriconazole or amphotericin B in a one-to-one ratio
Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US This azole has been shown active against Aspergillus spp in vitro and in animal models and early human trials to be effective against aspergillosis It has been shown to be well-tolerated and is available in an intravenous and oral formulation
This study will evaluate the efficacy safety and toleration of voriconazole compared to conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis in immunocompromised patients Patients will be randomized to open-labelled therapy with voriconazole or amphotericin B in a one-to-one ratio
Detailed Description:
Invasive aspergillosis is a fungal disease which is increasing in incidence with the increase in immunocompromised persons in our population Persons with prolonged neutropenia secondary to cytotoxic chemotherapies are at the highest risk for acute aspergillosis Patients undergoing bone marrow transplantation receiving prolonged corticosteroid or other immunosuppressive therapies and persons with HIV infection and AIDS are also at risk Even with antifungal therapy aspergillosis in its acute invasive forms has a high mortality In bone marrow transplantation patients and in those whose infection involves the brain this mortality is greater than 90 Amphotericin B in its conventional form is the current standard treatment for this disease Response to therapy with amphotericin B usually ranges between 20-60 in most studies The higher response rates are usually seen in those patients who can tolerate this agent for at least 14 days Because of its nephrotoxicity and other adverse effects alternatives to conventional amphotericin B have been sought These currently include liposomal forms of amphotericin B and itraconazole Although these forms show a decrease in adverse effects the efficacy of these drugs 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 Aspergillus sp in vitro and in animal models and early human trials to be effective against aspergillosis It has been shown to be well-tolerated and is available in an intravenous and oral formulation
This study will evaluate the efficacy safety and toleration of voriconazole compared to conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis in immunocompromised patients Although the original protocol allows enrollment of subjects older than 12 years old we do not expect to enroll patients younger than 18 years old Patients will be randomized to open-labelled therapy with voriconazole or amphotericin B in a one-to-one ratio
Voriconazole is an investigational antifungal drug currently being brought to phase III trials in the US This azole has been shown active against Aspergillus sp in vitro and in animal models and early human trials to be effective against aspergillosis It has been shown to be well-tolerated and is available in an intravenous and oral formulation
This study will evaluate the efficacy safety and toleration of voriconazole compared to conventional therapy with amphotericin B as primary treatment of acute invasive aspergillosis in immunocompromised patients Although the original protocol allows enrollment of subjects older than 12 years old we do not expect to enroll patients younger than 18 years old Patients will be randomized to open-labelled therapy with voriconazole or amphotericin B in a one-to-one ratio
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 |
|---|---|---|---|
| 97-I-0164 | None | None | None |