Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079222
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2004-03-08
Brief Title:
Voriconazole Compared With Itraconazole in Preventing Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Randomized Trial Of Safety And Tolerability Of IntravenousOral Voriconazole Versus IntravenousOral Itraconazole For Long-Term Antifungal Prophylaxis In Allogeneic Hematopoietic Stem Cell Transplant Recipients
Status:
COMPLETED
Status Verified Date:
2013-01
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 Antifungals such as voriconazole and itraconazole may be effective in preventing fungal infections in patients who are undergoing allogeneic stem cell transplantation
PURPOSE This randomized clinical trial is studying voriconazole to see how well it works compared to itraconazole in preventing fungal infections in patients who are undergoing allogeneic hematopoietic stem cell transplantation
PURPOSE This randomized clinical trial is studying voriconazole to see how well it works compared to itraconazole in preventing fungal infections in patients who are undergoing allogeneic hematopoietic stem cell transplantation
Detailed Description:
OBJECTIVES
Compare the safety and tolerability of voriconazole vs itraconazole for the prevention of fungal infections in patients undergoing allogeneic hematopoietic stem cell transplantation
OUTLINE This is a randomized study Patients are stratified according to donor type related vs unrelated Patients are randomized to 1 of 2 treatment arms
Arm I Beginning after allogeneic hematopoietic stem cell transplantation AHSCT patients receive voriconazole IV twice daily on days 1-14 and then orally twice daily on days 15-100
Arm II Beginning after AHSCT patients receive itraconazole IV twice daily on days 1-2 once daily on days 3-14 and then orally twice daily on days 15-100
NOTE Patients unable to tolerate oral medication may continue IV medication beyond day 14
In both arms treatment continues in the absence of unacceptable toxicity or an invasive fungal infection Patients requiring corticosteroid therapy for graft-versus-host disease continue to receive voriconazole or itraconazole beyond day 100
Patients are followed until day 180 post-transplantation
PROJECTED ACCRUAL A total of 150 patients 75 per treatment arm will be accrued for this study
Compare the safety and tolerability of voriconazole vs itraconazole for the prevention of fungal infections in patients undergoing allogeneic hematopoietic stem cell transplantation
OUTLINE This is a randomized study Patients are stratified according to donor type related vs unrelated Patients are randomized to 1 of 2 treatment arms
Arm I Beginning after allogeneic hematopoietic stem cell transplantation AHSCT patients receive voriconazole IV twice daily on days 1-14 and then orally twice daily on days 15-100
Arm II Beginning after AHSCT patients receive itraconazole IV twice daily on days 1-2 once daily on days 3-14 and then orally twice daily on days 15-100
NOTE Patients unable to tolerate oral medication may continue IV medication beyond day 14
In both arms treatment continues in the absence of unacceptable toxicity or an invasive fungal infection Patients requiring corticosteroid therapy for graft-versus-host disease continue to receive voriconazole or itraconazole beyond day 100
Patients are followed until day 180 post-transplantation
PROJECTED ACCRUAL A total of 150 patients 75 per treatment arm will be accrued for this study
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 |
|---|---|---|---|
| UCLA-0307071 | None | None | None |