Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-01-06 @ 9:55 PM
Study NCT ID:
NCT03248960
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2017-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 381}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-30', 'studyFirstSubmitDate': '2017-08-10', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by iTreat Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by iTreat Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by iTreat Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by iTreat Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}], 'secondaryOutcomes': [{'measure': 'Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by iTreat Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants positive for influenza A by RT-PCR, the percentage who are positive for influenza A by ellume.lab Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by iTreat Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants negative for influenza A by RT-PCR, the percentage who are negative for influenza A by ellume.lab Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by iTreat Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants positive for influenza B by RT-PCR, the percentage who are positive for influenza B by ellume.lab Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by iTreat Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Of participants negative for influenza B by RT-PCR, the percentage who are negative for influenza B by ellume.lab Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Percent of participants who correctly interpret result of iTreat Flu A+B Test.', 'timeFrame': '1 day', 'description': 'Agreement between trained staff and participants. Report as a percentage of participants with 95% confidence limits'}, {'measure': 'Scores from questionnaire to assess ease of use, comfort and convenience of iTreat Flu A+B Test.', 'timeFrame': '1 day', 'description': 'The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).'}, {'measure': 'Scores from questionnaire to assess ease of use and convenience of ellume.lab Flu A+B Test.', 'timeFrame': '1 day', 'description': 'The ease of use questionnaire will provide total number of responses to each question and the percentage of participants selecting each response (on a 5 point Likert scale).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': "The primary purpose of this study is to validate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture.\n\nThe secondary aims are to:\n\nValidate the sensitivity and specificity of the iTreat Flu A+B Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).\n\nEvaluate the correct interpretation of the iTreat Flu A+B Test by subjects with influenza-like symptoms.\n\nEvaluate the subjects' satisfaction with the convenience, comfort and ease of use of the iTreat Flu A+B Test.\n\nEvaluate the operators' satisfaction with the ease of use of the ellume.lab Flu A+B Test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants aged ≥ 18 years: iTreat Flu A+B Test and ellume.lab Flu A+B Test OR aged ≥ 1 and \\<18 years: ellume.lab Flu A+B Test only; and\n* Fever ≥ 37.8°C (100°F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8°C (100°F) or feeling feverish within 24 hours of presentation; and\n* Rhonorrhea or blocked nose; and\n* Participant (or parent/legal guardian) capable and willing to give informed consent/assent; and\n* Participant (or parent/legal guardian) able to read and write in English.\n\nExclusion Criteria:\n\n* Participants aged \\<1 year.\n* Participants who have undergone treatment with Tamiflu (oseltamivir), Relenza (zanamivir) or Symmetral (amantadine) within the previous 7 days.\n* Participants who have been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.\n* Participants who have had a nose bleed within the past 30 days.\n* Participants who have had recent craniofacial injury or surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months.\n* Participants currently enrolled in another clinical trial or have used any investigational device within 30 days preceding informed consent.\n* Participants 18 years of age or older unable to understand English and consent to participation.\n* Parent/legal guardian of Paticipants \\<18 years of age unable to understand English and consent to participation of child.\n* Participants who have had prior exposure to iTreat Flu A+B Test.\n* participants who have been previously enrolled in the iE-FLU-AUS-1701 study.'}, 'identificationModule': {'nctId': 'NCT03248960', 'briefTitle': 'Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ellume Pty Ltd'}, 'officialTitle': 'A Prospective Multi-Centre Study of the Ellume.Lab Flu A+B Test and iTreat Flu A+B Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction.', 'orgStudyIdInfo': {'id': 'iE-FLU-AUS-1701'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'iTreat Flu A+B Test and ellume.lab Flu A+B Test', 'description': 'Upper respiratory tract samples from participants will be tested with:\n\niTreat Flu A+B Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR); and viral culture.', 'interventionNames': ['Diagnostic Test: iTreat Flu A+B Test', 'Diagnostic Test: ellume.lab Flu A+B Test', 'Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)', 'Diagnostic Test: Viral culture']}], 'interventions': [{'name': 'iTreat Flu A+B Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes.', 'armGroupLabels': ['iTreat Flu A+B Test and ellume.lab Flu A+B Test']}, {'name': 'ellume.lab Flu A+B Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The ellume.lab Flu A+B Test is an in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasal swab samples. The ellume.lab Flu A+B Test generates a result within 10 minutes.', 'armGroupLabels': ['iTreat Flu A+B Test and ellume.lab Flu A+B Test']}, {'name': 'Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.', 'armGroupLabels': ['iTreat Flu A+B Test and ellume.lab Flu A+B Test']}, {'name': 'Viral culture', 'type': 'DIAGNOSTIC_TEST', 'description': 'Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.', 'armGroupLabels': ['iTreat Flu A+B Test and ellume.lab Flu A+B Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2913', 'city': 'Casey', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'Ochre Health Medical Centre Casey', 'geoPoint': {'lat': -35.16701, 'lon': 149.0947}}, {'zip': '2148', 'city': 'Blacktown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Paratus Clinical Blacktown Trial Clinic', 'geoPoint': {'lat': -33.76667, 'lon': 150.91667}}, {'zip': '2559', 'city': 'Kanwal', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Paratus Clinical Kanwal Trial Clinic', 'geoPoint': {'lat': -33.253, 'lon': 151.4911}}, {'zip': '4575', 'city': 'Buddina', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Coastal Family Health', 'geoPoint': {'lat': -26.69565, 'lon': 153.13302}}, {'zip': '4506', 'city': 'Morayfield', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Morayfield Family Doctors', 'geoPoint': {'lat': -27.10876, 'lon': 152.94907}}, {'zip': '4556', 'city': 'Sippy Downs', 'state': 'Queensland', 'country': 'Australia', 'facility': 'USC Health Clinics', 'geoPoint': {'lat': -26.71793, 'lon': 153.05475}}, {'zip': '4125', 'city': 'Southport', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Griffith University Clinical Trial Unit', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '3145', 'city': 'Malvern East', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Emeritus Research', 'geoPoint': {'lat': -37.87397, 'lon': 145.04253}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ellume Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}