Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients

Phase 3TerminatedNCT00031473

National Institute of Allergy and Infectious Diseases (NIAID)90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Respiratory Syncytial Virus Infections

Interventions

Virazole (Ribavirin) Inhalation SolutionDRUG

Eligibility

Sex: ALLMin age: 5 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (11)

University of Alabama at Birmingham (CASG)

Birmingham, Alabama, United States

City of Hope National Medical Center

Duarte, California, United States

University of California, San Francisco

San Francisco, California, United States

Data from ClinicalTrials.gov

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