Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420966
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2007-01-10
Brief Title:
Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Phase IV Study of Respiratory Syncytial Virus Monoclonal Antibody Therapy in High-risk Infants and Toddlers
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 5800 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None