Ribavirin With or Without Monoclonal Antibody Therapy in Treating Patients Who Develop RSV Pneumonia Following Peripheral Stem Cell Transplantation

Phase 3

Completed

• Conditions: Cancer

• Registration Number: NCT00014391
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

RATIONALE: Antivirals such as ribavirin are used to treat infections caused by viruses. It is not yet known if ribavirin is more effective with or without monoclonal antibody therapy in treating patients who develop RSV pneumonia following peripheral stem cell transplantation.

PURPOSE: Randomized phase III trial to compare the effectiveness of ribavirin with or without monoclonal antibody in treating patients who develop RSV pneumonia following peripheral stem cell transplantation.

Detailed Description

OBJECTIVES: I. Compare the efficacy, in terms of all-cause mortality reduction, of ribavirin with or without palivizumab in patients with respiratory syncytial virus pneumonia following stem cell transplantation. II. Determine the safety of these treatments in this patient population.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior ribavirin exposure for this infection (24 hours or more vs less than 24 hours) and requirement for ventilator support (yes vs no). Patients are randomized to one of two treatment arms. Arm I: Patients receive aerosolized ribavirin via face mask or oxygen tent over 2 hours 3 times daily or over 16-18 hours on days 1-10 and palivizumab IV 2 hours before ribavirin administration on day 1. Arm II: Patients receive aerosolized ribavirin as in arm I and placebo IV 2 hours before ribavirin administration on day 1. Patients are followed at 14, 21, and 28 days.

PROJECTED ACCRUAL: A total of 140 patients (70 per arm) will be accrued for this study within 2 years.

Study Timeline

• Study Start: 1999-02
• Study First Submitted: 2001-04-10
• Primary Completion: 2001-10
• Study Completion: 2001-10
• Study First Submitted QC: 2004-04-12
• Study First Posted: 2004-04-13
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-31
• Last Update Posted: 2010-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States