Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-26 @ 2:15 PM
Study NCT ID:
NCT01431768
Status:
COMPLETED
Last Update Posted:
2014-04-30
First Post:
2011-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007251', 'term': 'Influenza, Human'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-28', 'studyFirstSubmitDate': '2011-09-07', 'studyFirstSubmitQcDate': '2011-09-09', 'lastUpdatePostDateStruct': {'date': '2014-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of Influenza A', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity of Influenza B', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influenza', 'Human', 'Orthomyxoviridae infections', 'RNA Virus Infections', 'Virus Diseases', 'Respiratory Tract infections', 'Respiratory Tract Diseases'], 'conditions': ['Influenza']}, 'descriptionModule': {'briefSummary': 'This is a open label, prospective, pair comparison, randomised, multi-centre trial. The primary aim of this study to is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza A as compared with (a) the best available rapid Influenza A test in the market Quidel QuickVue (QQV) and (b) the gold standard for identifying Influenza A infection Polymerase Chain Reaction (PCR).\n\nThe secondary aim is to clinically validate the sensitivity and specificity of the Respirio Flu Test (RFT) in detecting Influenza B as compared to QQV and PCR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female subjects aged between 7 and 80 years (inclusive);\n2. Fever \\> 37.5 or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever;\n3. Cough or sore throat;\n4. Rhinorrhea or nasal congestion;\n5. ≤ 5 days from onset of clinical Influenza - Like Illness (ILI) symptoms;\n6. Subject (or parent/guardian) capable and willing to give informed consent;\n7. Subject provides written assent according to his/her age, if applicable.\n\nExclusion Criteria:\n\n1. Recent craniofacial abnormality or injury (last 3 months);\n2. Nasal or sinus surgery, including surgery to correct deviation of the nasal septum, within the previous 6 months;\n3. Craniofacial abnormality, such as severe deviation of the nasal septum;\n4. Onset of clinical Influenza - Like Illness (ILI) symptoms \\> 5 days;\n5. Know history of allergic reaction to plastics or adhesives;\n6. Subject (or parent/guardian) unwilling or unable to give informed consent.'}, 'identificationModule': {'nctId': 'NCT01431768', 'briefTitle': 'Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Respirio Pty Ltd'}, 'officialTitle': 'Clinical Validation of the Respirio Flu Test for the Rapid Identification of Influenza A/B in the Primary Health Setting', 'orgStudyIdInfo': {'id': 'RESP11001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Respirio Flu Test', 'type': 'DEVICE', 'description': "The Respirio Flu Test (RFT) is a rapid test for identifying whether a patient is infected with the Influenza A or B virus. The test separates the Influenza virus from the patient's nose blow sample and utilizes the same underlying technology as a pregnancy test (lateral flow/immuno-chromatography) to deliver a positive or negative result in less than 10 minutes. The RFT is easy to use, designed with a 3 step process similar to that of the home pregnancy test. Results are presented to the patient as a combination of different coloured lines, depending on whether the patient has Influenza A or B."}]}, 'contactsLocationsModule': {'locations': [{'zip': '4068', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Taringa 7 Day Medical Practice', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}, {'zip': '4157', 'city': 'Brisbane', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Capalaba Medical Centre', 'geoPoint': {'lat': -27.46794, 'lon': 153.02809}}], 'overallOfficials': [{'name': 'Julie Todhunter, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unaffliated'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Respirio Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}