Intermittent Use of Aerosolized Ribavirin for Treatment of RSV

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objectives:

1. To determine whether aerosolized ribavirin is effective when given at an intermittent dose over 3 hours every 8 hours for therapy of RSV upper respiratory tract infection (URI) and whether it can prevent progression to pneumonia.

2. To determine the effect of this regimen on persistence of viral shedding.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: ICN Pharmaceuticals
• Treatments: Ribavirin

Criteria

Inclusion Criteria:

1. Patients with these underlying malignancies will be eligible for this study:

Autologous BMT patients, Allogeneic BMT patients, and patients with hematological malignancy.

2. Patients must be at least 5 years of age.

3. Only patients with infection limited to the URT will be eligible for entry on study

4. Patients will be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing or by a positive culture for RSV.

Exclusion Criteria:

1. Patients with evidence of RSV LRTI as documented by a positive rapid RSV antigen testing or by a positive culture for RSV from a nasopharyngeal wash or throat swab AND new infiltrates on chest radiograph and/or abnormal blood gas determination

2. Patients with hypersensitivity to ribavirin or its components

3. Pregnant women. Participants must practice birth control during the study if they are sexually active. If the participant is pregnant, she may not be enrolled on this study. Mothers should refrain from breast-feeding during the study to avoid injury to their children.

4. Patients with positive RSV by rapid testing or culture in bronchoalveolar lavage regardless of the chest radiographic results.