- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00031473
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
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham (CASG)
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California
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Duarte, California, United States, 91010
- City of Hope National Medical Center
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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Illinois
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Chicago, Illinois, United States, 60637
- University Of Chicago
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Indiana
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Indianapolis, Indiana, United States, 46202
- J. Whitcomb Riley Hosp for Chldrn - Indianapolis
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Missouri
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Kansas City, Missouri, United States, 64134
- St. Luke's Hospital (Kansas City, MO)
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Nebraska
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Omaha, Nebraska, United States, 68198
- University of Nebraska Medical Center
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New York
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
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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.
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
Additional Relevant MeSH Terms
- RNA Virus Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Paramyxoviridae Infections
- Mononegavirales Infections
- Pneumovirus Infections
- Infections
- Virus Diseases
- Pneumonia
- Respiratory Syncytial Virus Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
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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