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

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.

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.

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.