Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014391
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2001-04-10
Brief Title:
Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase III Study To Evaluate The Safety And Efficacy Of Palivizumab Combined With Aerosolized Ribavirin Compared To Ribavirin Alone To Treat RSV Pneumonia In Patients With Bone Marrow Transplants BMT
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 with or without monoclonal antibody therapy in treating patients who develop RSV pneumonia following peripheral stem cell transplantation
PURPOSE Randomized phase III trial to compare the effectiveness of ribavirin with or without monoclonal antibody in treating patients who develop RSV pneumonia following peripheral stem cell transplantation
PURPOSE Randomized phase III trial to compare the effectiveness of ribavirin with or without monoclonal antibody in treating patients who develop RSV pneumonia following peripheral stem cell transplantation
Detailed Description:
OBJECTIVES I Compare the efficacy in terms of all-cause mortality reduction of ribavirin with or without palivizumab in patients with respiratory syncytial virus pneumonia following stem cell transplantation II Determine the safety of these treatments in this patient population
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior ribavirin exposure for this infection 24 hours or more vs less than 24 hours and requirement for ventilator support yes vs no Patients are randomized to one of two treatment arms Arm I Patients receive aerosolized ribavirin via face mask or oxygen tent over 2 hours 3 times daily or over 16-18 hours on days 1-10 and palivizumab IV 2 hours before ribavirin administration on day 1 Arm II Patients receive aerosolized ribavirin as in arm I and placebo IV 2 hours before ribavirin administration on day 1 Patients are followed at 14 21 and 28 days
PROJECTED ACCRUAL A total of 140 patients 70 per arm will be accrued for this study within 2 years
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to prior ribavirin exposure for this infection 24 hours or more vs less than 24 hours and requirement for ventilator support yes vs no Patients are randomized to one of two treatment arms Arm I Patients receive aerosolized ribavirin via face mask or oxygen tent over 2 hours 3 times daily or over 16-18 hours on days 1-10 and palivizumab IV 2 hours before ribavirin administration on day 1 Arm II Patients receive aerosolized ribavirin as in arm I and placebo IV 2 hours before ribavirin administration on day 1 Patients are followed at 14 21 and 28 days
PROJECTED ACCRUAL A total of 140 patients 70 per arm will be accrued for this study within 2 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 |
|---|---|---|---|
| FHCRC-137900 | None | None | None |
| NCI-G01-1929 | None | None | None |
| CDR0000068540 | REGISTRY | PDQ | None |