Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2026-01-03 @ 6:34 PM
Study NCT ID:
NCT00420966
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2007-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25003}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-13', 'studyFirstSubmitDate': '2007-01-10', 'studyFirstSubmitQcDate': '2007-01-10', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine palivizumab outcome measures', 'timeFrame': 'Per respiratory syncytial virus season', 'description': 'The objectives of this study are:\n\n* To determine palivizumab usage patterns, annually\n* To understand palivizumab infant demographics, including: potential neonatal, familial and environmental risk factors\n* To determine reasons for hospitalization, respiratory syncytial virus hospitalization rates, length of stay, morbidity and mortality\n* To determine intensive care unit admissions, length of stay, use of respiratory support (e.g., mechanical ventilation, CPAP) and complication rates\n* To determine compliance rates\n* To collect safety data'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lower respiratory tract infection', 'respiratory syncytial virus infections', 'palivizumab', 'outcomes', 'utilization', 'compliance'], 'conditions': ['Lower Respiratory Tract Infection', 'Respiratory Syncytial Virus Infections']}, 'referencesModule': {'references': [{'pmid': '21343842', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '22546928', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23989104', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '24799541', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26237402', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '26780032', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '27331856', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23861694', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '22203430', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '27649365', 'type': 'RESULT', 'citation': "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."}, {'pmid': '28105526', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '28403044', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '29557081', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '32235248', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32232817', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30985509', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30517603', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nWith 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children who have received at least one dose of palivizumab.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All children who receive at least one dose of palivizumab\n\nExclusion Criteria:\n\n* The child's parent or legal guardian could not communicate in either English or French\n* The child had received palivizumab as part of a clinical trial during the study period"}, 'identificationModule': {'nctId': 'NCT00420966', 'briefTitle': 'Utilization and Compliance of Respiratory Syncytial Virus Monoclonal Antibody Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'Phase IV Study of Respiratory Syncytial Virus Monoclonal Antibody Therapy in High-risk Infants and Toddlers', 'orgStudyIdInfo': {'id': '456-2005'}}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': "Alberta Children's Hospital", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "McMaster Children's Hospital", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Ian Mitchell, MB, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}, {'name': 'Krista L Lanctôt, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}, {'name': 'Bosco Paes, MD, FRCPC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}