Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-28 @ 1:17 PM
Study NCT ID:
NCT00921895
Status:
COMPLETED
Last Update Posted:
2021-11-03
First Post:
2009-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003231', 'term': 'Conjunctivitis'}, {'id': 'D003236', 'term': 'Conjunctivitis, Viral'}, {'id': 'D007637', 'term': 'Keratoconjunctivitis'}], 'ancestors': [{'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015828', 'term': 'Eye Infections, Viral'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007634', 'term': 'Keratitis'}, {'id': 'D003316', 'term': 'Corneal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sambursky@rpsdetectors.com', 'phone': '941-556-1853', 'title': 'Robert Sambusky, MD', 'organization': 'Rapid Pathogen Screening, Inc.'}, 'certainAgreement': {'otherDetails': "Results to be published or presented shall be submitted to RPS for review and comment at least 30 days prior to submission for publication or presentation. Institution and/or PI may publish or present the results and data from the Institution's site individually (i) 12 months after conclusion, abandonment or termination of study at all sites, or (ii) after RPS confirms there will be no multicenter study publication, whichever occurs first.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Device Testing', 'description': 'Patients with conjunctivitis will be tested with the RPS Adeno Detector IV', 'otherNumAtRisk': 128, 'otherNumAffected': 0, 'seriousNumAtRisk': 128, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RPS Adeno Detector IV (Sensitivity)', 'description': 'Looking for the number of true positives as compared to cell culture.'}, {'id': 'OG001', 'title': 'RPS Adeno Detector IV (Specificity)', 'description': 'Looking for the number of true negatives as compared to cell culture.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '98.0'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '89.8', 'upperLimit': '98.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '15 minutes', 'description': 'Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.', 'unitOfMeasure': 'percentage of cases', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Device Testing', 'description': 'Patients with conjunctivitis will be tested with the RPS Adeno Detector IV'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The recruitment period was June 2009 - May 2011. The study was performed at private ophthalmology practices and academic centers.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Device Testing', 'description': 'Patients with conjunctivitis will be tested with the RPS Adeno Detector IV'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '5', 'upperLimit': '90'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '52', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '128', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-01', 'studyFirstSubmitDate': '2009-06-14', 'resultsFirstSubmitDate': '2012-08-22', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-08-22', 'studyFirstPostDateStruct': {'date': '2009-06-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity of RPS Adeno Detector IV Compared to Cell Culture.', 'timeFrame': '15 minutes', 'description': 'Sensitivity is proportion of true positive cases compared to cell culture. Specificity is the proportion of true negative cases compared to cell culture.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pink Eye,', 'Viral conjunctivitis', 'Adenoviral conjunctivitis', 'Keratoconjunctivitis'], 'conditions': ['Conjunctivitis']}, 'referencesModule': {'references': [{'pmid': '23307204', 'type': 'DERIVED', 'citation': 'Sambursky R, Trattler W, Tauber S, Starr C, Friedberg M, Boland T, McDonald M, DellaVecchia M, Luchs J. Sensitivity and specificity of the AdenoPlus test for diagnosing adenoviral conjunctivitis. JAMA Ophthalmol. 2013 Jan;131(1):17-22. doi: 10.1001/2013.jamaophthalmol.513.'}]}, 'descriptionModule': {'briefSummary': "To engage in a multi-center, prospective, masked clinical trial to investigate a non-invasive, rapid diagnostic test, the RPS Adeno Detector IV's ability to detect the presence of the adenovirus (ADV) antigen in cases of acute conjunctivitis by comparing it to cell culture with confirmatory immunofluorescence (CC-IFA). The polymerase chain reaction (PCR) will be used as a referee for discrepant cases.", 'detailedDescription': 'The RPS Adeno Detector IV will show substantial equivalence to cell culture for diagnosing adenoviral conjunctivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A total of 150 patients will be enrolled and who present prospectively to either a private practice or academic center with a presumed diagnosis of acute viral conjunctivitis while an internal review board (IRB) approved ophthalmologist is available and determined by the ophthalmologist to have met the following criteria for the clinical diagnosis of acute viral conjunctivitis will be included in the study.\n* Criteria for clinical diagnosis of viral conjunctivitis. Requires that patients are at least 1 month old and present within 7 days of developing a red eye with at least 1 criteria from each of the 3 categories below:\n\nI History: 1) Spread from 1 eye to the other several days later, 2) a recent history of an upper respiratory infection (URI)\n\nII Signs: 1) presence of follicles, 2) presence of a preauricular node\n\nIII Symptoms: 1) watery - purulent discharge, 2) eyelash matting, 3) itching, or 4) foreign body sensation\n\nExclusion Criteria:\n\n* Patients with allergy to corn starch, talcum powder, or dacron will be excluded.\n* Patients with a corneal ulcer or history of recent trauma will also be excluded.\n* Any patients who are using any topical ointment (including OTC artificial tear ointments) in the last 72 hours should be excluded.\n* Patients using other topical ophthalmic medications (i.e. antibiotics) must allow 60 minutes prior to device application following any topical ophthalmic drops.'}, 'identificationModule': {'nctId': 'NCT00921895', 'briefTitle': 'A Comparison of the RPS Adeno Detector IV to Viral Cell Culture at Detecting Adenoviral Conjunctivitis', 'nctIdAliases': ['NCT00799318'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Lumos Diagnostics'}, 'officialTitle': 'A Comparison of the Sensitivity and Specificity of the RPS Adeno Detector IV™ at Detecting the Presence of Adenovirus to Viral Cell Culture.', 'orgStudyIdInfo': {'id': '200-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device Testing', 'description': 'Patients with conjunctivitis will be tested with the RPS Adeno Detector IV', 'interventionNames': ['Device: RPS Adeno Detector IV']}], 'interventions': [{'name': 'RPS Adeno Detector IV', 'type': 'DEVICE', 'description': 'One time test with the RPS Adeno Detector IV', 'armGroupLabels': ['Device Testing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Manatee Eye Clinic', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33176', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Center For Excellence in Eye Care', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': "St John's Clinic", 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '11563', 'city': 'Lynbrook', 'state': 'New York', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Long Island', 'geoPoint': {'lat': 40.65483, 'lon': -73.6718}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill-Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11793', 'city': 'Wantagh', 'state': 'New York', 'country': 'United States', 'facility': 'South Shore Eye Care', 'geoPoint': {'lat': 40.68371, 'lon': -73.51013}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Wills Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '18503', 'city': 'Scranton', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Northeastern Eye Institute', 'geoPoint': {'lat': 41.40916, 'lon': -75.6649}}], 'overallOfficials': [{'name': 'Shachar Tauber, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St John's Clinic"}, {'name': 'Jodi Luchs, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'South Shore Eye Clinic'}, {'name': 'William Trattler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center For Excellence In Eye Care'}, {'name': 'Thomas Boland, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northeastern Eye Institute'}, {'name': 'Michael DellaVecchia, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wills Eye Institute'}, {'name': 'Murray Friedberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Manatee Eye Clinic'}, {'name': 'Chris Starr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}, {'name': 'Marguerite McDonald, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Consultants of Long Island'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rapid Pathogen Screening', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}