Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral 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 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.
|Study Design:||Primary Purpose: Supportive Care|
|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)|
|Study Start Date:||February 1999|
|Study Completion Date:||October 2001|
|Primary Completion Date:||October 2001 (Final data collection date for primary outcome measure)|
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.
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||Michael Boeckh, MD||Fred Hutchinson Cancer Research Center|