Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003883
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
1999-11-01
Brief Title:
Itraconazole Compared With Fluconazole to Prevent Infections in Patients Undergoing Peripheral Stem Cell or Bone Marrow Transplantation
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Randomized Comparative Study of Itraconazole Versus Fluconazole for Prevention of Aspergillus Infections in Peripheral Blood Stem Cell and Marrow Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2010-03
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:
RATIONALE Giving itraconazole or fluconazole may be effective in preventing infections in patients undergoing peripheral stem cell or bone marrow transplantation It is not yet known whether itraconazole is more effective than fluconazole for preventing infections
PURPOSE Randomized phase III trial to compare the effectiveness of itraconazole with fluconazole to prevent infections in patients undergoing peripheral stem cell or bone marrow transplantation
PURPOSE Randomized phase III trial to compare the effectiveness of itraconazole with fluconazole to prevent infections in patients undergoing peripheral stem cell or bone marrow transplantation
Detailed Description:
OBJECTIVES I Compare the efficacy of itraconazole versus fluconazole in reducing the incidence of breakthrough Aspergillus infections in patients undergoing allogeneic peripheral blood stem cell or bone marrow transplantation II Compare the incidence of combined moldyeast infections and the use of alternative systemic antifungal treatments in these patients on this regimen III Compare the toxic effects of these two drugs in these patients IV Determine the survival rate of these patients
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms Arm I Patients receive fluconazole orally or IV daily beginning at start of conditioning regimen and continuing until day 180 or until 4 weeks after stopping corticosteroids if it occurs between days 120-180 Arm II Patients receive oral fluconazole daily beginning at start of conditioning regimen and continuing until day 0 Patients then receive itraconazole orally or IV daily beginning on day 0 and continuing until day 180 or until 4 weeks after stopping corticosteroids if it occurs between days 120-180
PROJECTED ACCRUAL A total of 578 patients 289 per arm will be accrued for this study within 4 years
OUTLINE This is a randomized study Patients are randomized to one of two treatment arms Arm I Patients receive fluconazole orally or IV daily beginning at start of conditioning regimen and continuing until day 180 or until 4 weeks after stopping corticosteroids if it occurs between days 120-180 Arm II Patients receive oral fluconazole daily beginning at start of conditioning regimen and continuing until day 0 Patients then receive itraconazole orally or IV daily beginning on day 0 and continuing until day 180 or until 4 weeks after stopping corticosteroids if it occurs between days 120-180
PROJECTED ACCRUAL A total of 578 patients 289 per arm will be accrued for this study within 4 years
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 |
|---|---|---|---|
| CDR0000067050 | REGISTRY | PDQ | None |
| FHCRC-132200 | None | None | None |
| NCI-H99-0030 | None | None | None |