Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Completed

CT.gov ID

NCT00420966

Collaborator

Abbott (Industry)

25,003

Enrollment

Locations

140.8

Duration (Months)

12501.5

Patients Per Site

88.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Respiratory Tract Infection Respiratory Syncytial Virus Infections

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 Design

Study Type:

Observational

Actual Enrollment :

25003 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2005

Actual Primary Completion Date :

Jun 26, 2017

Actual Study Completion Date :

Jun 26, 2017

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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