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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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00031473
Enrollment
90
Registered
2002-03-07
Start date
1997-11-30
Completion date
2003-03-31
Last updated
2010-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Syncytial Virus Infections

Keywords

Ribavirin, RSV

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.

Interventions

DRUGVirazole (Ribavirin) Inhalation Solution

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
5 Years to 60 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026