Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients

August 26, 2010 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1997

Study Completion

March 1, 2003

Study Registration Dates

First Submitted

March 6, 2002

First Submitted That Met QC Criteria

March 6, 2002

First Posted (Estimate)

March 7, 2002

Study Record Updates

Last Update Posted (Estimate)

August 27, 2010

Last Update Submitted That Met QC Criteria

August 26, 2010

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97-038

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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