Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00016081
Status:
COMPLETED
Last Update Posted:
2010-03-30
First Post:
2001-05-06
Brief Title:
Ribavirin Compared With Standard Care in Treating Patients With Respiratory Syncytial Virus Following Stem Cell Transplantation
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Randomized Phase III Study To Evaluate The Safety And Efficacy Or Ribavirin Inhaled Solution In Preventing Progression Of Upper Respiratory Tract Respiratory Syncytial Virus RSV Infection To RSV Pneumonia In Blood And Bone Marrow Transplant BMT 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 Antivirals such as ribavirin are used to treat infections caused by viruses It is not yet known if ribavirin is more effective than standard therapy in preventing pneumonia in patients who have respiratory syncytial virus RSV infection following stem cell transplantation
PURPOSE Randomized phase III trial to compare the effectiveness of ribavirin with that of standard therapy in preventing pneumonia in patients who have RSV infection following stem cell transplantation
PURPOSE Randomized phase III trial to compare the effectiveness of ribavirin with that of standard therapy in preventing pneumonia in patients who have RSV infection following stem cell transplantation
Detailed Description:
OBJECTIVES
Compare the efficacy of aerosolized ribavirin vs standard supportive therapy in terms of preventing progression of upper respiratory tract respiratory syncytial virus RSV infection to pneumonia in patients with RSV following stem cell transplantation
Determine the safety of aerosolized ribavirin in this patient population
OUTLINE This is a randomized investigator-blind controlled multicenter study Patients are stratified according to engraftment status pre vs post and transplant type HLA matched-related allogeneic syngeneic or autologous vs HLA mismatched-related or unrelated allogeneic Patients are randomized to one of two treatment arms
Arm I Patients receive standard supportive care for immunocompromised patients with upper respiratory tract infections Patient also receive aerosolized ribavirin by face mask mist or oxygen tent over 2 hours 3 times daily on days 1-10
Arm II Patients receive standard supportive care as in arm I Treatment continues in the absence of progression to pneumonia or unacceptable toxicity
Patients are followed at days 14 and 28
PROJECTED ACCRUAL A total of 90 patients 45 per arm will be accrued for this study
Compare the efficacy of aerosolized ribavirin vs standard supportive therapy in terms of preventing progression of upper respiratory tract respiratory syncytial virus RSV infection to pneumonia in patients with RSV following stem cell transplantation
Determine the safety of aerosolized ribavirin in this patient population
OUTLINE This is a randomized investigator-blind controlled multicenter study Patients are stratified according to engraftment status pre vs post and transplant type HLA matched-related allogeneic syngeneic or autologous vs HLA mismatched-related or unrelated allogeneic Patients are randomized to one of two treatment arms
Arm I Patients receive standard supportive care for immunocompromised patients with upper respiratory tract infections Patient also receive aerosolized ribavirin by face mask mist or oxygen tent over 2 hours 3 times daily on days 1-10
Arm II Patients receive standard supportive care as in arm I Treatment continues in the absence of progression to pneumonia or unacceptable toxicity
Patients are followed at days 14 and 28
PROJECTED ACCRUAL A total of 90 patients 45 per 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 |
|---|---|---|---|
| CDR0000068593 | REGISTRY | PDQ | None |
| FHCRC-129000 | None | None | None |
| NCI-G01-1939 | None | None | None |