Respiratory Syncytial Virus Infections Clinical Trial
Official title:
Phase IV Study of Respiratory Syncytial Virus Monoclonal Antibody Therapy in High-risk Infants and Toddlers
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.
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.
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