Infection Clinical Trial
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
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.
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.
;
Allocation: Randomized, Primary Purpose: Supportive Care
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