Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Virazole (Ribavirin) Inhalation Solution
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus Infections focused on measuring Ribavirin, RSV
Eligibility 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.
Sites / Locations
- University of Alabama at Birmingham (CASG)
- City of Hope National Medical Center
- University of California, San Francisco
- University of Florida
- University of Chicago
- J. Whitcomb Riley Hosp for Chldrn - Indianapolis
- University of Maryland
- University of Minnesota
- St. Luke's Hospital (Kansas City, MO)
- University of Nebraska Medical Center
- SUNY Upstate Medical University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00031473
First Posted
March 6, 2002
Last Updated
August 26, 2010
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00031473
Brief Title
Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients
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 Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Terminated
Study Start Date
November 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Ribavirin, RSV
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Virazole (Ribavirin) Inhalation Solution
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Alabama at Birmingham (CASG)
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
J. Whitcomb Riley Hosp for Chldrn - Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
St. Luke's Hospital (Kansas City, MO)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64134
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
12. IPD Sharing Statement
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Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients
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