Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Terminated; Phase 3

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: Virazole (Ribavirin) Inhalation Solution

Study type: Interventional

Funder types: NIH

Identifiers

NCT00031473

97-038

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 5 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind