Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients

Last updated: August 26, 2010
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Overall Status: Terminated

Phase

3

Condition

Pneumonia

Treatment

N/A

Clinical Study ID

NCT00031473
97-038
  • Ages 5-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

INCLUSION CRITERIA:

  • 2 years of age or older.

  • Are not pregnant or breast-feeding and agree to use a reliable birth control methodfor 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

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.

Study Design

Total Participants: 90
Study Start date:
November 01, 1997
Estimated Completion Date:
March 31, 2003

Study 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.

Connect with a study center

  • University of Alabama at Birmingham (CASG)

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Site Not Available

  • J. Whitcomb Riley Hosp for Chldrn - Indianapolis

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • St. Luke's Hospital (Kansas City, MO)

    Kansas City, Missouri 64134
    United States

    Site Not Available

  • University of Nebraska Medical Center

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

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