Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00031473
• Other study ID #: 97-038
• Status: Terminated
• Phase: Phase 3
• First received: March 6, 2002
• Last updated: August 26, 2010
• Start date: November 1997
• Est. completion date: March 2003

Study information

• Verified date: December 2003
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00001098

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• Virus Diseases

Intervention

Drug:
• Virazole (Ribavirin) Inhalation Solution

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama at Birmingham (CASG)	Birmingham	Alabama
United States	University of Chicago	Chicago	Illinois
United States	City of Hope National Medical Center	Duarte	California
United States	University of Florida	Gainesville	Florida
United States	J. Whitcomb Riley Hosp for Chldrn - Indianapolis	Indianapolis	Indiana
United States	St. Luke's Hospital (Kansas City, MO)	Kansas City	Missouri
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of California, San Francisco	San Francisco	California
United States	SUNY Upstate Medical University	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States,