Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy

Completed

• Conditions: Respiratory Syncytial Virus Infections; Lower Respiratory Tract Infection

• Registration Number: NCT00420966
• Lead Sponsor: Sunnybrook Health Sciences Centre

Brief Summary

The purpose of this study is to determine the utilization patterns and compliance rates of palivizumab, which is a monoclonal antibody therapy used to prevent respiratory syncytial virus infection.

Detailed Description

Respiratory syncytial virus (RSV) is the most important viral respiratory pathogen in children. Infection due to RSV represents a large public health burden; in Canada, it accounts for 5,800 hospitalizations annually. The peak incidence of RSV disease occurs between 2-6 months of age with half of all infants infected in the first year of life. Palivizumab has been approved for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high-risk of RSV disease. These children include those born premature, those with bronchopulmonary dysplasia (BPD), and those with hemodynamically significant congenital heart disease (CHD).

With the recent approval of palivizumab in Canada, access to this medication has increased. However, there are limited data on utilization, compliance, and health outcomes, particularly the frequency and severity of RSV infections. The primary objective of this study is to provide insight into the current management (utilization, compliance) of children at high-risk of RSV infection with palivizumab prophylaxis in the tertiary care centers and community settings through the development of a Canadian Registry Database.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2007-01-10
• Study First Submitted QC: 2007-01-10
• Study First Posted: 2007-01-11
• Primary Completion: 2017-06-26
• Study Completion: 2017-06-26
• Status Verified: 2017-09
• Last Update Submitted: 2018-04-13
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25003

Inclusion Criteria

• All children who receive at least one dose of palivizumab

Exclusion Criteria

• The child's parent or legal guardian could not communicate in either English or French
• The child had received palivizumab as part of a clinical trial during the study period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine palivizumab outcome measures	Per respiratory syncytial virus season	The objectives of this study are: * To determine palivizumab usage patterns, annually; * To understand palivizumab infant demographics, including: potential neonatal, familial and environmental risk factors; * To determine reasons for hospitalization, respiratory syncytial virus hospitalization rates, length of stay, morbidity and mortality; * To determine intensive care unit admissions, length of stay, use of respiratory support (e.g., mechanical ventilation, CPAP) and complication rates; * To determine compliance rates; * To collect safety data

Trial Locations

Locations (2)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada

McMaster Children's Hospital; 🇨🇦 Hamilton, Ontario, Canada