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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00016081
First received: May 6, 2001
Last updated: March 26, 2010
Last verified: March 2010
  Purpose

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 Intervention Phase
Infection
Drug: ribavirin
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Study Start Date: March 1998
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 2 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Pulmonary:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • Not specified

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00016081

Locations
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
Investigators
Study Chair: Michael Boeckh, MD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00016081     History of Changes
Other Study ID Numbers: 1290.00, FHCRC-1290.00, NCI-G01-1939, CDR0000068593
Study First Received: May 6, 2001
Last Updated: March 26, 2010
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
infection

Additional relevant MeSH terms:
Communicable Diseases
Infection
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014