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
- 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.
Allocation: Randomized, Primary Purpose: Supportive Care
Michael Boeckh, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|University of Alabama at Birmingham Comprehensive Cancer Center||Birmingham, Alabama 35294-3300|
|Siteman Cancer Center||Saint Louis, Missouri 63110|