Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy
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.
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 Design
Time Perspective: Prospective
Conditions
Lower Respiratory Tract Infection
Location
Alberta Children's Hospital
Calgary
Alberta
Canada
T3B 6A8
Status
Recruiting
Source
Sunnybrook Health Sciences Centre
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00420966
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Respiratory Tract Fistula
An abnormal passage communicating between any component of the respiratory tract or between any part of the respiratory system and surrounding organs.
Respiratory Dead Space
That part of the RESPIRATORY TRACT or the air within the respiratory tract that does not exchange OXYGEN and CARBON DIOXIDE with pulmonary capillary blood.
Cefonicid
A second-generation cephalosporin administered intravenously or intramuscularly. Its bactericidal action results from inhibition of cell wall synthesis. It is used for urinary tract infections, lower respiratory tract infections, and soft tissue and bone infections.
Granuloma, Respiratory Tract
Granulomatous disorders affecting one or more sites in the respiratory tract.
Signs And Symptoms, Respiratory
Respiratory system manifestations of diseases of the respiratory tract or of other organs.
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