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Lower Respiratory Tract InfectionNCT00420966

Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy

An observational study of Lower Respiratory Tract Infection and Respiratory Syncytial Virus Infections, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
How many people
25,003 participants
Where
2 sitesCanada
Study dates
Oct 2005to 26 Jun 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Children who have received at least one dose of palivizumab.

Who may be able to join

  • All children who receive at least one dose of palivizumab

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T3B 6A8

  • McMaster Children's Hospital

    Hamilton, Ontario, L8N 3Z5

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Keywords
lower respiratory tract infection, respiratory syncytial virus infections, palivizumab, outcomes, utilization, compliance
Medical subject headings
Respiratory Syncytial Virus Infections, Patient Acceptance of Health Care, Patient Compliance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Per respiratory syncytial virus season

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2007 (estimated)
  2. Study startOct 2005
  3. Primary completion26 Jun 2017
  4. Study completion26 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
25,003 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00420966
Sponsor's protocol ID
456-2005
Status last verified
Sep 2017
First submitted
10 Jan 2007
Last updated
17 Apr 2018
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21343842

  • 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.

    PubMed 22546928

  • 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.

    PubMed 23989104

  • 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.

    PubMed 24799541

  • 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.

    PubMed 26237402

  • 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.

    PubMed 26780032

  • 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.

    PubMed 27331856

  • 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.

    PubMed 23861694

  • 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.

    PubMed 22203430

  • 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.

    PubMed 27649365

  • 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.

    PubMed 28105526

  • 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.

    PubMed 28403044

  • 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.

    PubMed 29557081

  • 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.

    PubMed 32235248

  • 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.

    PubMed 32232817

Questions about this trial

What is this clinical trial studying?

An observational study of Lower Respiratory Tract Infection and Respiratory Syncytial Virus Infections, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine palivizumab outcome measures (time frame: Per respiratory syncytial virus season). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00420966, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.

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