Ribavirin Compared With Standard Care in Treating Patients With Respiratory Syncytial Virus Following Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00016081
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 30, 2010
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

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 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.

Condition or disease Intervention/treatment Phase
Infection Drug: ribavirin Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
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
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Confirmed upper respiratory tract respiratory syncytial virus (RSV) infection documented in nasopharyngeal-throat specimen by rapid antigen test (ELISA), IFA, or shell vial)

    • Signs or symptoms of upper respiratory tract infection (e.g., rhinorrhea and/or low-grade fever (under 101 degrees F with or without evidence of a sore throat)
  • Received prior stem cell transplantation (SCT) and meet one of the following criteria:

    • Between start of conditioning (preparative) regimen and day 90 after allogeneic, autologous, or syngeneic SCT
    • Between days 91 and 180 after unrelated or HLA mismatch-related allogeneic SCT
    • Between days 91 and 180 after SCT with graft-versus-host disease requiring systemic steroids expected to continue throughout study
  • No radiographic evidence of pneumonia



  • 2 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Oxygen saturation 92-100% by pulse oximeter
  • Normal respiratory rate for age


  • No prior adverse reactions to ribavirin
  • No clinical status that would preclude study
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study


Biologic therapy:

  • See Disease Characteristics
  • No prior immunotherapy for RSV
  • No prior or concurrent RSV hyperimmune globulin or monoclonal antibodies


  • Not specified

Endocrine therapy:

  • See Disease Characteristics


  • Not specified


  • Not specified


  • No prior antiviral drugs with anti-RSV activity
  • Bronchodilator treatment allowed for patients with asthma or a history of reactive airway disease and/or who develop bronchospasm
  • Concurrent ganciclovir, foscarnet, or IV immunoglobulin allowed
  • No mechanical ventilation
  • No other concurrent anti-viral drugs with anti-RSV activity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00016081

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
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Study Chair: Michael Boeckh, MD Fred Hutchinson Cancer Research Center Identifier: NCT00016081     History of Changes
Other Study ID Numbers: 1290.00
CDR0000068593 ( Registry Identifier: PDQ )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 30, 2010
Last Verified: March 2010

Keywords provided by Fred Hutchinson Cancer Research Center:

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents