Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005668
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2000-05-18
Brief Title:
A Multicenter Prospective Randomized Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Multicenter Prospective Randomized Double-Blind Clinical Trial Comparing Itraconazole Oral Solution in Cyclodextrin to Placebo in the Treatment of Aspergilloma
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:
To compare the safety and effectiveness of itraconazole oral solution to placebo in the treatment of a pulmonary aspergilloma
Aspergilloma is a fungal ball in the lungs caused by Aspergillus The infection can spread from the lungs through the blood to other organs Aspergilloma can be life-threatening therefore an effective treatment is needed
Aspergilloma is a fungal ball in the lungs caused by Aspergillus The infection can spread from the lungs through the blood to other organs Aspergilloma can be life-threatening therefore an effective treatment is needed
Detailed Description:
Patients are randomly selected to receive itraconazole oral solution by mouth or the inactive placebo oral cyclodextrin solution twice daily for 12 months
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 |
|---|---|---|---|
| DMID 96-199 | None | None | None |
| NIH09021 | None | None | None |