Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase IV Study of Respiratory Syncytial Virus Monoclonal Antibody Therapy in High-risk Infants and Toddlers

Conditions
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Lower Respiratory Tract Infection, Respiratory Syncytial Virus Infections

Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine palivizumab outcome measures | 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 | Per respiratory syncytial virus season | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lower respiratory tract infection, respiratory syncytial virus infections, palivizumab, outcomes, utilization, compliance