Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2025-12-26 @ 4:18 AM
Study NCT ID:
NCT05733559
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2023-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
QIAstat-Dx® Respiratory Panel Plus (RPP) Clinical Performance Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': "Nasopharyngeal Swab (NPS) collected per the manufacturer's instructions and eluted in Universal Transport Media (UTM) from subjects with signs and symptoms of respiratory infection"}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 565}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-02-16', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PPA', 'timeFrame': '8 weeks', 'description': 'positive percentage agreement'}, {'measure': 'NPA', 'timeFrame': '8 weeks', 'description': 'negative percentage agreement'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory Virus', 'SARS-CoV-2 coronavirus'], 'conditions': ['Respiratory Disease']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method', 'detailedDescription': 'This multicentre study aims to evaluation the clinical performance of the QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target with a validated comparator method'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with symptoms of respiratory infection', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Presenting with signs and symptoms of a respiratory infection.\n* Consent or assent to be obtained\n* Able to communicate (speak, read and write) in local language, and able to understand and sign the required study documents.\n* Willing and able to provide Nasopharyngeal Swab (NPS) Specimen collected per manufacturer's instructions.\n\nExclusion Criteria:\n\n* Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study."}, 'identificationModule': {'nctId': 'NCT05733559', 'briefTitle': 'QIAstat-Dx® Respiratory Panel Plus (RPP) Clinical Performance Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'QIAGEN Gaithersburg, Inc'}, 'officialTitle': 'An Observational Prospective Clinical Study to Assess Clinical Performance of QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 Target in the Intended Use Population and Environment', 'orgStudyIdInfo': {'id': 'DHF-18-0127-0-CSP-003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'QIAstat-Dx® Respiratory Panel Plus (RPP)', 'type': 'DEVICE', 'description': "An observational prospective performance evaluation study of QIAstat-Dx® Respiratory Panel Plus (RPP) SARS-CoV-2 target against a marketed comparator, using NPS collected per the manufacturer's instructions and eluted in Universal Transport Media (UTM) from subjects with signs and symptoms of respiratory infection"}]}, 'contactsLocationsModule': {'locations': [{'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'QIAGEN', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Sarah Johnson', 'role': 'STUDY_DIRECTOR', 'affiliation': 'QIAGEN Gaithersburg, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QIAGEN Gaithersburg, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}