Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:31 AM
Study NCT ID:
NCT06660433
Status:
RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Respiratory Outbreak Mitigation in Long-Term Care Using Point-of-Care Testing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster Randomized Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2024-10-24', 'studyFirstSubmitQcDate': '2024-10-24', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of long-term care residents infected with COVID-19, Influenza, or respiratory syncytial virus (RSV)', 'timeFrame': '7 months', 'description': 'The number of long-term care residents who contract Influenza, COVID-19 or RSV separated into the number of residents infected after an introduction is identified and the size of an outbreak of each virus.'}], 'secondaryOutcomes': [{'measure': 'The number of outbreaks of Influenza, COVID-19 or RSV', 'timeFrame': '7 months', 'description': 'The number of Influenza, COVID-19 or RSV outbreaks as declared by the local Public Health Unit'}, {'measure': 'The number of long-term care residents infected during an outbreak of Influenza, COVID-19 or RSV', 'timeFrame': '28 days', 'description': 'The number of long-term care residents with a confirmed or suspected Influenza, COVID-19 or RSV infection during each outbreak as tracked by the local Public Health Unit'}, {'measure': 'Frequency of hospital transfers for long-term care residents infected with Influenza, COVID-19 or RSV', 'timeFrame': '14 days', 'description': 'The number of hospital transfers for long-term care residents with Influenza, COVID-19 or RSV'}, {'measure': 'Number of deaths in long-term care residents infected with Influenza, COVID-19 or RSV', 'timeFrame': '28 days', 'description': 'The number of long-term care residents who die following an infection with Influenza, COVID-19 or RSV'}, {'measure': 'Duration of outbreaks in of Influenza, COVID-19 or RSV in long-term care facilities', 'timeFrame': '60 days', 'description': 'The total duration of an outbreak of Influenza, COVID-19 or RSV as declared by the local Public Health Unit'}, {'measure': 'Secondary attack rate of high-risk exposures to each long-term care resident with Influenza, COVID-19 or RSV infection', 'timeFrame': '28 days', 'description': 'The proportion of identified high risk contacts of an infected long-term care resident with Influenza, COVID-19 or RSV infection'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['respiratory virus outbreaks', 'outbreak mitigation', 'long-term care home'], 'conditions': ['Outbreaks']}, 'referencesModule': {'references': [{'pmid': '38659123', 'type': 'BACKGROUND', 'citation': "Tan C, Chan CK, Ofner M, O'Brien J, Thomas NR, Callahan J, Pascual B, Palmer SJ, Serapion V, Fabro H, Kozak RA, Candon H, Chan AK, Powis JE, Leis JA. Implementation of point-of-care molecular testing for respiratory viruses in congregate living settings. Infect Control Hosp Epidemiol. 2024 Apr 25;45(9):1-5. doi: 10.1017/ice.2024.72. Online ahead of print."}]}, 'descriptionModule': {'briefSummary': 'Outbreaks of seasonal respiratory viruses can spread rapidly in long-term care homes. Timely results for diagnostic tests remains a challenge for respiratory viruses due to the logistics of using a reference laboratory with delays leading to missed opportunities to implement virus-specific control measures to interrupt transmission resulting in larger outbreaks. Use of a point-of-care testing platform is a potential solution that provides faster results, but it is uncertain whether this translates into benefits for long-term care residents. This trial aims to assess whether rapid test results for respiratory pathogens (Influenza, Coronavirus disease of 2019 (COVID-19) and Respiratory Syncytial Virus) can impact the number and size of respiratory virus outbreaks in long-term care homes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Long-term care facility engaged with an Ontario Health Team overseen by Sunnybrook Health Science Centre, Michael Garron Hospital or Humber River Health\n\nExclusion Criteria:\n\n* No signed statement of agreement for study participation\n* Pre-existing use of a point-of-care testing platform'}, 'identificationModule': {'nctId': 'NCT06660433', 'acronym': 'PROMPT-LTC', 'briefTitle': 'Respiratory Outbreak Mitigation in Long-Term Care Using Point-of-Care Testing', 'organization': {'class': 'OTHER', 'fullName': 'Michael Garron Hospital'}, 'officialTitle': 'imProving Respiratory Outbreak Mitigation Through Point-of-care Testing in Long Term Care (PROMPT-LTC): A Cluster Randomized Trial', 'orgStudyIdInfo': {'id': 'CK-19-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Point-of-Care Polymerase Chain Reaction Testing Platform', 'interventionNames': ['Device: Point-of-care respiratory test platform']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Existing Testing Platform for Respiratory Viruses', 'interventionNames': ['Other: Existing respiratory virus testing platform']}], 'interventions': [{'name': 'Point-of-care respiratory test platform', 'type': 'DEVICE', 'description': 'A point-of-care respiratory multiplex testing platform situated within a long-term care facility to provide rapid test results', 'armGroupLabels': ['Point-of-Care Polymerase Chain Reaction Testing Platform']}, {'name': 'Existing respiratory virus testing platform', 'type': 'OTHER', 'description': 'Currently used respiratory virus testing platforms', 'armGroupLabels': ['Existing Testing Platform for Respiratory Viruses']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4C 3E7', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Christopher Kandel, MD, PhD', 'role': 'CONTACT', 'email': 'christopher.kandel@tehn.ca', 'phone': '416-469-6252'}], 'facility': 'Michael Garron Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jerome Leis, MD, MSc', 'role': 'CONTACT', 'email': 'jerome.leis@sunnybrook.ca', 'phone': '416-480-4243'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Christopher Kandel, MD, PhD', 'role': 'CONTACT', 'email': 'christopher.kandel@tehn.ca', 'phone': '416-469-6252'}, {'name': 'Jerome Leis, MD, MSc', 'role': 'CONTACT', 'email': 'jerome.leis@sunnybrook.ca', 'phone': '416-480-4243'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael Garron Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, {'name': 'Humber River Health', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}