Ribavirin Compared With Standard Care in Treating Patients With Respiratory Syncytial Virus Following Stem Cell Transplantation
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|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|
|Study Start Date:||March 1998|
|Study Completion Date:||March 2003|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
- 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.
|United States, Alabama|
|University of Alabama at Birmingham Comprehensive Cancer Center|
|Birmingham, Alabama, United States, 35233|
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Missouri|
|Siteman Cancer Center|
|Saint Louis, Missouri, United States, 63110|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Study Chair:||Michael Boeckh, MD||Fred Hutchinson Cancer Research Center|