Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2025-12-31 @ 8:21 PM
Study NCT ID:
NCT00682851
Status:
COMPLETED
Last Update Posted:
2016-09-22
First Post:
2008-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016585', 'term': 'Vaginosis, Bacterial'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lrabe@mwri.magee.edu', 'phone': '412-641-6042', 'title': 'Lorna Rabe', 'organization': 'Magee-Womens Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A major limitation of this study was that in the first 122 women, 24% of the cohort, the vaginal swabs used for the diagnostic tests were collected in random order, which resulted in decreased sensitivity of the OSOM Rapid and BVBLue tests.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Symptomatic', 'description': 'Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.', 'otherNumAtRisk': 251, 'otherNumAffected': 0, 'seriousNumAtRisk': 251, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Asymptomatic', 'description': 'Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).', 'otherNumAtRisk': 268, 'otherNumAffected': 0, 'seriousNumAtRisk': 268, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic', 'description': 'Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.'}, {'id': 'OG001', 'title': 'Asymptomatic', 'description': 'Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).'}], 'classes': [{'title': 'OSOM Rapid Test', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000', 'lowerLimit': '78', 'upperLimit': '98'}, {'value': '91', 'groupId': 'OG001', 'lowerLimit': '72', 'upperLimit': '99'}]}]}, {'title': 'PCR', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '85', 'upperLimit': '100'}]}]}, {'title': 'Wet Mount Microscopy', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000', 'lowerLimit': '41', 'upperLimit': '74'}, {'value': '48', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '69'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1', 'description': 'Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic', 'description': 'Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.'}, {'id': 'OG001', 'title': 'Asymptomatic', 'description': 'Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).'}], 'classes': [{'title': 'OSOM Rapid Test', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '97', 'upperLimit': '100'}]}]}, {'title': 'PCR', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '92', 'upperLimit': '98'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '98'}]}]}, {'title': 'Wet Mount Microscopy', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '99', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1', 'description': 'Specificity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed using the gold standard method) among those who have a negative test.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic', 'description': 'Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.'}, {'id': 'OG001', 'title': 'Asymptomatic', 'description': 'Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).'}], 'classes': [{'title': 'BVBlue Test', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '60', 'upperLimit': '76'}, {'value': '61', 'groupId': 'OG001', 'lowerLimit': '51', 'upperLimit': '71'}]}]}, {'title': 'Amsel Criteria', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '88'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '76'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1', 'description': 'Sensitivity of the BVBlue Test and Amsel criteria in diagnosing bacterial vaginosis using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Symptomatic', 'description': 'Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.'}, {'id': 'OG001', 'title': 'Asymptomatic', 'description': 'Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).'}], 'classes': [{'title': 'BVBlue Test', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '100'}]}]}, {'title': 'Amsel Criteria', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000', 'lowerLimit': '87', 'upperLimit': '98'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '98', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Visit 1', 'description': 'Specificity of the BVBlue Test and Amsel criteria in diagnosing BV using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed by the gold standard method) among those who have a negative test.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Symptomatic', 'description': 'Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.'}, {'id': 'FG001', 'title': 'Asymptomatic', 'description': 'Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '268'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '268'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '519', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Symptomatic', 'description': 'Women who presented with one or more symptoms of vaginitis including abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain.'}, {'id': 'BG001', 'title': 'Asymptomatic', 'description': 'Women who presented without any symptoms of vaginitis (abnormal vaginal odor, abnormal vaginal discharge, pruritis, vaginal burning or pain, vaginal irritation, or lower abdominal pain).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '239', 'groupId': 'BG000'}, {'value': '252', 'groupId': 'BG001'}, {'value': '491', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.3', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '27.0', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '27.6', 'spread': '8.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '519', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '519', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 519}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-15', 'studyFirstSubmitDate': '2008-05-16', 'resultsFirstSubmitDate': '2011-07-08', 'studyFirstSubmitQcDate': '2008-05-21', 'lastUpdatePostDateStruct': {'date': '2016-09-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-07-08', 'studyFirstPostDateStruct': {'date': '2008-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women', 'timeFrame': 'Visit 1', 'description': 'Sensitivity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.'}], 'secondaryOutcomes': [{'measure': 'Specificity of the OSOM Rapid Test and PCR Wet Mount Microscopy in Diagnosing Trichomonas Vaginalis in Symptomatic and Asymptomatic Women', 'timeFrame': 'Visit 1', 'description': 'Specificity of the OSOM Rapid test and PCR wet mount microscopy in diagnosing Trichomonas vaginalis using Trichomonas culture as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed using the gold standard method) among those who have a negative test.'}, {'measure': 'Sensitivity of the BVBlue Test and Amsel Criteria in Diagnosing Bacterial Vaginosis in Symptomatic and Asymptomatic Women.', 'timeFrame': 'Visit 1', 'description': 'Sensitivity of the BVBlue Test and Amsel criteria in diagnosing bacterial vaginosis using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The sensitivity of a test is the percentage of people who have the infection (as diagnosed by the gold standard method) among those who have a positive test.'}, {'measure': 'Specificity of the BVBlue Test and Amsel Criteria in Diagnosing BV in Symptomatic and Asymptomatic Women.', 'timeFrame': 'Visit 1', 'description': 'Specificity of the BVBlue Test and Amsel criteria in diagnosing BV using Gram Stain (Nugent scoring) as the gold standard in symptomatic and asymptomatic women. The specificity of a test is the percentage of people who do not have the infection (as diagnosed by the gold standard method) among those who have a negative test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bacterial Vaginosis', 'Urogenital Infection by Trichomonas Vaginalis']}, 'descriptionModule': {'briefSummary': 'This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests to diagnose common vaginal infections.', 'detailedDescription': 'This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests (that take up to 7 days to get results) to diagnose common vaginal infections (Trichomonas and bacterial vaginosis).\n\nBoth rapid tests (OSOM and BVBlue) are approved by the Food and Drug Administration (FDA) to be used by healthcare professionals to aid in the diagnosis of these infections. This study is being done to validate (or confirm)the accuracy of these tests. This study may help researchers decide if these tests could be used in remote research settings (in place of the standard office testing) to increase diagnosis and prompt treatment of these vaginal infections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-pregnant women between the ages of 18 and 60, with or without symptoms of vaginitis, were recruited for this study from Magee-Womens Hospital of University of Pittsburgh Medical Center and Allegheny County Health Department.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 15 years of age at time of enrollment\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Currently menstruating or bleeding\n* Use of an antibiotic to treat bacterial vaginosis or Trichomonas within the past 7 days'}, 'identificationModule': {'nctId': 'NCT00682851', 'briefTitle': 'A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test', 'orgStudyIdInfo': {'id': 'PRO08020012'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OSOM Trichomonas Rapid Test', 'type': 'DEVICE', 'description': 'Rapid test run using vaginal discharge collected via a cotton swab'}, {'name': 'OSOM BVBlue Test', 'type': 'DEVICE', 'description': 'Rapid test run using vaginal discharge collected using a cotton swab'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Magee-Womens Hospital of UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Sharon L Hillier, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Sharon Hillier', 'investigatorAffiliation': 'University of Pittsburgh'}}}}