Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy

April 13, 2018 updated by: Sunnybrook Health Sciences Centre

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

25003

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children who have received at least one dose of palivizumab.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Per respiratory syncytial virus season

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Collaborators

Abbott

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 26, 2017

Study Completion (Actual)

June 26, 2017

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 10, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 456-2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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