Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients
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
1 other identifier
interventional
90
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 1997
Longer than P75 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1997
CompletedFirst Submitted
Initial submission to the registry
March 6, 2002
CompletedFirst Posted
Study publicly available on registry
March 7, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2003
CompletedAugust 27, 2010
December 1, 2003
March 6, 2002
August 26, 2010
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Alabama at Birmingham (CASG)
Birmingham, Alabama, 35294, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
University of California, San Francisco
San Francisco, California, 94143, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Chicago
Chicago, Illinois, 60637, United States
J. Whitcomb Riley Hosp for Chldrn - Indianapolis
Indianapolis, Indiana, 46202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
St. Luke's Hospital (Kansas City, MO)
Kansas City, Missouri, 64134, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
March 6, 2002
First Posted
March 7, 2002
Study Start
November 1, 1997
Study Completion
March 1, 2003
Last Updated
August 27, 2010
Record last verified: 2003-12