Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00420966
Recruitment Status : Completed
First Posted : January 11, 2007
Last Update Posted : April 17, 2018
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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
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 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 : October 2005
Actual Primary Completion Date : June 26, 2017
Actual Study Completion Date : June 26, 2017

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Determine palivizumab outcome measures [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children who have received at least one dose of palivizumab.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00420966

Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Principal Investigator: Ian Mitchell, MB, FRCPC University of Calgary
Study Director: Krista L Lanctôt, PhD Sunnybrook Health Sciences Centre
Study Director: Bosco Paes, MD, FRCPC McMaster University

Publications of Results:

Responsible Party: Sunnybrook Health Sciences Centre Identifier: NCT00420966     History of Changes
Other Study ID Numbers: 456-2005
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: September 2017

Keywords provided by Sunnybrook Health Sciences Centre:
lower respiratory tract infection
respiratory syncytial virus infections

Additional relevant MeSH terms:
Communicable Diseases
Virus Diseases
Respiratory Tract Infections
Respiratory Syncytial Virus Infections
Respiratory Tract Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs