Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy

Respiratory Syncytial Virus Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00420966
• Other study ID #: 456-2005
• Status: Completed
• First received: January 10, 2007
• Last updated: April 13, 2018
• Start date: October 2005
• Est. completion date: June 26, 2017

Study information

• Verified date: September 2017
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25003
• Est. completion date: June 26, 2017
• Est. primary completion date: June 26, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Lower Respiratory Tract Infection
• Respiratory Syncytial Virus Infections
• Respiratory Tract Infections
• Virus Diseases

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta
Canada	McMaster Children's Hospital	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Abbott

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Bjornson C, Chan P, Li A, Paes B, Lanctôt 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 Mar 19. doi: 10.1007/s10096-018-3225-7. [Epub ahead o — View Citation

Chan P, Li A, Paes B, Abraha H, Mitchell I, Lanctôt 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.00000 — View Citation

Chen JJ, Chan P, Paes B, Mitchell I, Li A, Lanctôt 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: 1 — View Citation

Hui C, Paes B, Papenburg J, Mitchell I, Li A, Lanctôt KL; CARESS Investigators. Palivizumab Adherence and Outcomes in Canadian Aboriginal Children. Pediatr Infect Dis J. 2016 Nov;35(11):1187-1193. — View Citation

Li A, Wang DY, Lanctôt 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. — View Citation

Manzoni P, Paes B, Lanctôt 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 St — View Citation

Mitchell I, Paes BA, Li A, Lanctôt KL; CARESS investigators. CARESS: the Canadian registry of palivizumab. Pediatr Infect Dis J. 2011 Aug;30(8):651-5. doi: 10.1097/INF.0b013e31821146f7. — View Citation

Paes B, Mitchell I, Li A, Harimoto T, Lanctôt 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/ — View Citation

Paes B, Mitchell I, Li A, Lanctôt 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. Erratum in: Eur J Pediatr. 2012 — View Citation

Paes B, Mitchell I, Li A, Lanctôt 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):27 — View Citation

Paes B, Mitchell I, Yi H, Li A, Lanctôt 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.00000000000000 — View Citation

Wang DY, Li A, Paes B, Mitchell I, Lanctôt 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 Ja — View Citation

Yi H, Lanctôt 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/pe — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine palivizumab outcome measures	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