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Completed

NCT Number: NCT00420966

Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Alberta Children's Hospital, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Abbott

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2007
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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