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Ribavirin to Prevent RSV Pneu...

Ribavirin to Prevent RSV Pneumonia in Bone Marrow Transplant Patients

Last Updated: 2010-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-11-30

Study Completion Date

2003-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Virazole (Ribavirin) Inhalation Solution

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers