Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2026-02-27 @ 4:33 PM
Study NCT ID:
NCT03251261
Status:
COMPLETED
Last Update Posted:
2019-01-14
First Post:
2017-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Cytomegalovirus Virus in Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Prospectively collected saliva swabs from neonates up to 21 days of age Retrospective well characterized positive saliva samples will also be tested'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1615}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-11', 'studyFirstSubmitDate': '2017-08-14', 'studyFirstSubmitQcDate': '2017-08-15', 'lastUpdatePostDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative detection of CMV to aid in the diagnosis of CMV', 'timeFrame': 'within 30 days of sample collection', 'description': 'Test each sample for CMV detection'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['CMV']}, 'descriptionModule': {'briefSummary': 'To evaluate the illumigene CMV assay, using the illumipro-10 with neonates (up to 21 days of age) saliva swabs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '20 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Saliva swab specimens from all neonates up to 21 days of age may be collected and tested', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Saliva swab specimens from neonates up to 21 days of age\n* Saliva swab sample placed in a nonnutritive transport medium or in a plastic sterile tube without medium.\n* Flocked-nylon swabs\n\nExclusion Criteria:\n\n* Samples other than saliva swab from patients up to 21 days of age.\n* Swabs other than flocked-nylon.\n* Swabs in a viral transport media not defined in the Investigational Use Only package insert\n* Multiple specimens from the same patient.\n* Specimens received in the laboratory in unsatisfactory containers or condition.'}, 'identificationModule': {'nctId': 'NCT03251261', 'acronym': 'CMV', 'briefTitle': 'Detection of Cytomegalovirus Virus in Neonates', 'organization': {'class': 'INDUSTRY', 'fullName': 'Meridian Bioscience, Inc.'}, 'officialTitle': 'Illumigene CMV Clinical Trial Protocol', 'orgStudyIdInfo': {'id': 'CLIN-DHF-333-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Specimen collection', 'interventionNames': ['Device: illumigene CMV assay, illumipro-10']}], 'interventions': [{'name': 'illumigene CMV assay, illumipro-10', 'type': 'DEVICE', 'description': 'CMV assay for detection of CMV', 'armGroupLabels': ['Specimen collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '2031', 'city': 'Randwick', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'The Prince of Wales Hospital', 'geoPoint': {'lat': -33.91439, 'lon': 151.24895}}, {'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Coloumbia', 'country': 'Canada', 'facility': "British Columbia Children's Hospital / British Columbia Women's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': '40138', 'city': 'Via Massarenti 19', 'state': 'Province of Bologna', 'country': 'Italy', 'facility': "Ospedale Sant'Orsola"}], 'overallOfficials': [{'name': 'Julie M Kesler', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Meridian Bioscience'}, {'name': 'Ken Kozak', 'role': 'STUDY_CHAIR', 'affiliation': 'Meridian Bioscience'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meridian Bioscience, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}