Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT03595358
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
2018-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ellume·Lab Flu A+B Test and the Ellume Home 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': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-12', 'studyFirstSubmitDate': '2018-07-11', 'studyFirstSubmitQcDate': '2018-07-11', 'lastUpdatePostDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza A by Ellume Home Flu Test.', 'timeFrame': '1 day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.'}, {'measure': 'Of participants positive for influenza A by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.'}, {'measure': 'Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza A by Ellume Home Flu Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.'}, {'measure': 'Of participants negative for influenza A by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.'}, {'measure': 'Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are positive for influenza B by Ellume Home Flu Test.', 'timeFrame': '1 day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.'}, {'measure': 'Of participants positive for influenza B by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.'}, {'measure': 'Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), the percentage who are negative for influenza B by Ellume Home Flu Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.'}, {'measure': 'Of participants negative for influenza B by Reverse Transcriptase Polymerase Chain Reaction (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 intervals.'}], 'secondaryOutcomes': [{'measure': 'Of participants positive for influenza A by viral culture, the percentage who are positive for influenza A by Ellume Home Flu Test.', 'timeFrame': '1 day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.'}, {'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': '1day', 'description': 'Establish sensitivity against a gold standard. Report as a percentage of participants with 96% confidence intervals.'}, {'measure': 'Of participants negative for influenza A by viral culture, the percentage who are negative for influenza A by Ellume Home Flu Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.'}, {'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 intervals.'}, {'measure': 'Of participants positive for influenza B by viral culture, the percentage who are positive for influenza B by Ellume Home Flu 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 intervals.'}, {'measure': 'Of participants negative for influenza B by viral culture, the percentage who are negative for influenza B by Ellume Home Flu Test.', 'timeFrame': '1 day', 'description': 'Establish specificity against a gold standard. Report as a percentage of participants with 96% confidence intervals.'}, {'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 intervals.'}, {'measure': 'Percent of participants who correctly interpret the result of the Ellume Home Flu Test', 'timeFrame': '1 day', 'description': 'Agreement between trained staff and participants. Report as a percentage of participants with 96% confidence limits.'}, {'measure': 'Scores from questionnaire to assess ease of use, comfort and convenience of the Ellume Home Flu 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 the 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': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': "The primary purpose of the study is to validate the sensitivity and specificity of the Ellume Home Flu 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\nSecondary aims are to:\n\nValidate the sensitivity and specificity of the Ellume Home Flu Test and the ellume.lab Flu A+B Test in detecting influenza A and influenza B as compared to viral culture; Evaluate the participant's satisfaction with the convenience and ease of use of the Ellume Home Flu Test; Evaluate the participant's interpretation of the Ellume Home Flu Test results compared to the interpretation by site staff; Evaluate the operator's satisfaction and ease of use of the ellume·lab Flu A+B Test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants aged ≥ 2 years; and\n* Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation; and\n* Rhinorrhea; and\n* ≤ 72 hours from onset of ILI symptoms; 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 \\< 2 years.\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 used any investigational device within 30 days preceding informed consent.\n* Participants previously enrolled in IE-FLU-AUS-1801;\n* Participants 18 years of age or older unable to understand English and consent to participation;\n* Parent/legal guardian of participants \\< 18 years of age unable to understand English and consent to participation of child.'}, 'identificationModule': {'nctId': 'NCT03595358', 'briefTitle': 'Ellume·Lab Flu A+B Test and the Ellume Home 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 the Ellume Home Flu Test Performance Versus Viral Culture and Reverse Transcriptase Polymerase Chain Reaction', 'orgStudyIdInfo': {'id': 'IE-FLU-AUS-1801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm', 'description': 'Ellume Home Flu Test and ellume.lab Flu A+B Test\n\nUpper respiratory tract samples from participants will be tested with:\n\nEllume Home Flu Test; ellume.lab Flu A+B Test; Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) and viral culture.', 'interventionNames': ['Diagnostic Test: Ellume Home Flu Test', 'Diagnostic Test: ellume.lab Flu A+B Test', 'Diagnostic Test: Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)', 'Diagnostic Test: Viral culture']}], 'interventions': [{'name': 'Ellume Home Flu Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The Ellume Home Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples.', 'armGroupLabels': ['Arm']}, {'name': 'ellume.lab Flu A+B Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The ellume.lab Flu A+B Test is a rapid 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.', 'armGroupLabels': ['Arm']}, {'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': ['Arm']}, {'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': ['Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2559', 'city': 'Kanwal', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Paratus Clinical Kanwal Trial Clinic', 'geoPoint': {'lat': -33.253, 'lon': 151.4911}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ellume Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}