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Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients

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.
 
ClinicalTrials.gov Identifier: NCT00031473
Recruitment Status : Terminated
First Posted : March 7, 2002
Last Update Posted : August 27, 2010
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The purpose of this study is to test the safety and effectiveness of ribavirin, administered as an aerosol, in preventing progression of upper respiratory tract RSV infection to RSV pneumonia in bone marrow and peripheral blood transplant recipients.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: Virazole (Ribavirin) Inhalation Solution Phase 3

Detailed Description:
The study enrolls 90 transplant recipients with positive nasal/throat culture specimens for Respiratory Syncytial Virus (RSV) infection. Patients are randomized into one of two groups: investigational treatment or standard treatment.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: A Randomized Phase III Study to Evaluate the Safety and Efficacy of Ribavirin Inhaled Solution in Preventing Progression of Upper Respiratory Tract Respiratory Syncytial Virus Infection to RSV Pneumonia in Blood and Bone Marrow Transplant (BMT) Recipient
Study Start Date : November 1997
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

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Ages Eligible for Study:   5 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • 2 years of age or older.
  • Are not pregnant or breast-feeding and agree to use a reliable birth control method for the duration of the study.
  • Are a blood or bone marrow transplant recipient.
  • Have evidence of upper respiratory tract infection.
  • Have nasopharyngeal-throat samples positive for RSV.

EXCLUSION CRITERIA:

  • Are known to be HIV positive.
  • Have pneumonia.
  • Require a ventilator to breathe.
  • Are pregnant.
  • Are breast-feeding and are unwilling to stop breast-feeding.
  • Are receiving treatment with certain other drugs for RSV.

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 ClinicalTrials.gov identifier (NCT number): NCT00031473


Locations
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United States, Alabama
University of Alabama at Birmingham (CASG)
Birmingham, Alabama, United States, 35294
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
J. Whitcomb Riley Hosp for Chldrn - Indianapolis
Indianapolis, Indiana, United States, 46202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. Luke's Hospital (Kansas City, MO)
Kansas City, Missouri, United States, 64134
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

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ClinicalTrials.gov Identifier: NCT00031473    
Obsolete Identifiers: NCT00001098
Other Study ID Numbers: 97-038
First Posted: March 7, 2002    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: December 2003
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ribavirin
RSV
Additional relevant MeSH terms:
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Infection
Respiratory Syncytial Virus Infections
Pneumonia
Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents