Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008840
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2001-01-18
Brief Title:
A Randomized Open Label Comparative Multicenter Trial of Voriconazole Vs AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Open Label Comparative Multicenter Trial of Voriconazole Vs AmBisome for Empirical Antifungal Therapy in Immunocompromised Patients With Persistent Fever and Neutropenia
Status:
COMPLETED
Status Verified Date:
2005-11
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:
The purpose of this study is to evaluate the safety and effectiveness of 2 drugs AmBisome versus voriconazole in treating fungal infections Immunocompromised patients especially those with persistent fever and neutropenia are at a high risk of developing deeply invasive life-threatening fungal infections with Candida Aspergillus and other opportunistic fungal pathogens The risk of fungal infection increases in direct proportion with severity of neutropenia and duration of fever Antifungal therapy therefore is an important step in the amelioration of fungal disease
Detailed Description:
Patients are first split into groups to receive either voriconazole or AmBisome Both drugs are given through a vein IV for at least 3 days At the conclusion of 3 days the voriconazole patients are then switched to oral voriconazole The AmBisome patients continue with IV AmBisome Both groups continue treatment until blood counts increase and fever subsides
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 150-603 | None | None | None |