Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy
NCT ID: NCT00420966
Last Updated: 2018-04-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
25003 participants
Study Classification
OBSERVATIONAL
Study Start Date
2005-10-31
Study Completion Date
2017-06-26
Brief Summary
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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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Detailed Description
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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.
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.
Conditions
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Lower Respiratory Tract Infection
Respiratory Syncytial Virus Infections
Study Design
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Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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
* The child had received palivizumab as part of a clinical trial during the study period
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Abbott
INDUSTRY
Sponsor Role
collaborator
Sunnybrook Health Sciences Centre
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ian Mitchell, MB, FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Krista L Lanctôt, PhD
Role: STUDY_DIRECTOR
Sunnybrook Health Sciences Centre
Bosco Paes, MD, FRCPC
Role: STUDY_DIRECTOR
McMaster University
Locations
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Alberta Children's Hospital
Calgary, Alberta, Canada
Site Status
McMaster Children's Hospital
Hamilton, Ontario, Canada
Site Status
Countries
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Canada
References
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Mitchell I, Paes BA, Li A, Lanctot KL; CARESS investigators. CARESS: the Canadian registry of palivizumab. Pediatr Infect Dis J. 2011 Aug;30(8):651-5. doi: 10.1097/INF.0b013e31821146f7.
Reference Type
RESULT
Paes B, Mitchell I, Li A, Lanctot KL; CARESS Investigators. A comparative study of respiratory syncytial virus (RSV) prophylaxis in premature infants within the Canadian Registry of Palivizumab (CARESS). Eur J Clin Microbiol Infect Dis. 2012 Oct;31(10):2703-11. doi: 10.1007/s10096-012-1617-7. Epub 2012 May 1.
Reference Type
RESULT
Paes B, Mitchell I, Yi H, Li A, Lanctot KL; CARESS Investigators. Hospitalization for respiratory syncytial virus illness in Down syndrome following prophylaxis with palivizumab. Pediatr Infect Dis J. 2014 Feb;33(2):e29-33. doi: 10.1097/INF.0000000000000019.
Reference Type
RESULT
Yi H, Lanctot KL, Bont L, Bloemers BL, Weijerman M, Broers C, Li A, Kiss A, Mitchell I, Paes B; CARESS investigators. Respiratory syncytial virus prophylaxis in Down syndrome: a prospective cohort study. Pediatrics. 2014 Jun;133(6):1031-7. doi: 10.1542/peds.2013-3916. Epub 2014 May 5.
Reference Type
RESULT
Chen JJ, Chan P, Paes B, Mitchell I, Li A, Lanctot KL; CARESS investigators. Serious Adverse Events in the Canadian Registry of Children Receiving Palivizumab (CARESS) for Respiratory Syncytial Virus Prevention. PLoS One. 2015 Aug 3;10(8):e0134711. doi: 10.1371/journal.pone.0134711. eCollection 2015.
Reference Type
RESULT
Chan P, Li A, Paes B, Abraha H, Mitchell I, Lanctot KL; CARESS investigators. Adherence to Palivizumab for Respiratory Syncytial Virus Prevention in the Canadian Registry of Palivizumab. Pediatr Infect Dis J. 2015 Dec;34(12):e290-7. doi: 10.1097/INF.0000000000000922.
Reference Type
RESULT
Hui C, Paes B, Papenburg J, Mitchell I, Li A, Lanctot KL; CARESS Investigators. Palivizumab Adherence and Outcomes in Canadian Aboriginal Children. Pediatr Infect Dis J. 2016 Nov;35(11):1187-1193. doi: 10.1097/INF.0000000000001282.
Reference Type
RESULT
Paes B, Mitchell I, Li A, Harimoto T, Lanctot KL. Respiratory-related hospitalizations following prophylaxis in the Canadian registry for palivizumab (2005-2012) compared to other international registries. Clin Dev Immunol. 2013;2013:917068. doi: 10.1155/2013/917068. Epub 2013 Jun 19.
Reference Type
RESULT
Paes B, Mitchell I, Li A, Lanctot KL. Respiratory hospitalizations and respiratory syncytial virus prophylaxis in special populations. Eur J Pediatr. 2012 May;171(5):833-41. doi: 10.1007/s00431-011-1654-8. Epub 2011 Dec 28.
Reference Type
RESULT
Manzoni P, Paes B, Lanctot KL, Dall'Agnola A, Mitchell I, Calabrese S, Maule M, Girardi E, Harimoto T, Li A. Outcomes of Infants Receiving Palivizumab Prophylaxis for Respiratory Syncytial Virus in Canada and Italy: An International, Prospective Cohort Study. Pediatr Infect Dis J. 2017 Jan;36(1):2-8. doi: 10.1097/INF.0000000000001340.
Reference Type
RESULT
Wang DY, Li A, Paes B, Mitchell I, Lanctot KL; CARESS Investigators. First versus second year respiratory syncytial virus prophylaxis in chronic lung disease (2005-2015). Eur J Pediatr. 2017 Mar;176(3):413-422. doi: 10.1007/s00431-017-2849-4. Epub 2017 Jan 20.
Reference Type
RESULT
Li A, Wang DY, Lanctot KL, Mitchell I, Paes BA; CARESS Investigators. Comparing First- and Second-year Palivizumab Prophylaxis in Patients With Hemodynamically Significant Congenital Heart Disease in the CARESS Database (2005-2015). Pediatr Infect Dis J. 2017 May;36(5):445-450. doi: 10.1097/INF.0000000000001357.
Reference Type
RESULT
Bjornson C, Chan P, Li A, Paes B, Lanctot KL, Mitchell I. Palivizumab prophylaxis for respiratory syncytial virus in infants with cystic fibrosis: is there a need? Eur J Clin Microbiol Infect Dis. 2018 Jun;37(6):1113-1118. doi: 10.1007/s10096-018-3225-7. Epub 2018 Mar 19.
Reference Type
RESULT
Paes BA, Saleem M, Li A, Lanctot KL, Mitchell I; CARESS Investigators. Respiratory Syncytial Virus Prophylaxis in Immunocompromised Children: Outcomes From the Canadian RSV Evaluation Study of Palivizumab Registry Over Twelve Seasons (2005-2017). Pediatr Infect Dis J. 2020 Jun;39(6):539-545. doi: 10.1097/INF.0000000000002665.
Reference Type
DERIVED
Paes B, Li A, Kim D, Lanctot KL, Mitchell I; CARESS Investigators. A Comparison of Respiratory Syncytial Viral Prophylaxis in Multiple Births versus Singletons in the Canadian Registry of Palivizumab. Am J Perinatol. 2021 Aug;38(S 01):e129-e136. doi: 10.1055/s-0040-1708804. Epub 2020 Mar 31.
Reference Type
DERIVED
Wang DY, Saleem M, Paes BA, Mitchell I, Li A, Lanctot KL; CARESS Investigators. Respiratory Syncytial Virus Prophylaxis in Neurologic and Muscular Disorders in the Canadian Respiratory Syncytial Virus Evaluation Study of Palivizumab. Pediatr Infect Dis J. 2019 Aug;38(8):775-780. doi: 10.1097/INF.0000000000002297.
Reference Type
DERIVED
Kim D, Saleem M, Paes B, Mitchell I, Lanctot KL. Respiratory Syncytial Virus Prophylaxis in Infants With Congenital Diaphragmatic Hernia in the Canadian Respiratory Syncytial Virus Evaluation Study of Palivizumab, 2005-2017. Clin Infect Dis. 2019 Aug 30;69(6):980-986. doi: 10.1093/cid/ciy1010.
Reference Type
DERIVED
Other Identifiers
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456-2005
Identifier Type: -
Identifier Source: org_study_id
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