NCT00031473TerminatedPhase 3
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
National Institute of Allergy and Infectious Diseases (NIAID)22 sites in 1 country90 target enrollmentStarted: November 1997Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 90
- Locations
- 22
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single
Eligibility Criteria
- Ages
- 5 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Investigators
Study Sites (22)
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