Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-02-27 @ 3:13 AM
Study NCT ID:
NCT03098394
Status:
TERMINATED
Last Update Posted:
2023-08-31
First Post:
2017-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D006069', 'term': 'Gonorrhea'}, {'id': 'D002690', 'term': 'Chlamydia Infections'}], 'ancestors': [{'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D002694', 'term': 'Chlamydiaceae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016133', 'term': 'Polymerase Chain Reaction'}], 'ancestors': [{'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gwilkerson@som.umaryland.edu', 'phone': '4103285555', 'title': 'Richard Gentry Wilkerson', 'organization': 'University of Maryland School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects enrolled'}}, 'adverseEventsModule': {'timeFrame': '7 Days', 'eventGroups': [{'id': 'EG000', 'title': 'Rapid Turnaround Test', 'description': 'Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.\n\nCepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.\n\nPolymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.\n\nPolymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Treated With Antibiotics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Turnaround Test', 'description': 'Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.\n\nCepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.\n\nPolymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.\n\nPolymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Length of Stay (Minutes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Turnaround Test', 'description': 'Subjects who received the RTAT'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects who were assigned to the usual care group only'}], 'classes': [{'categories': [{'measurements': [{'value': '200.6896552', 'spread': '48.12936692', 'groupId': 'OG000'}, {'value': '129.6060606', 'spread': '60.9717862', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Who Received Both RTAT and Usual Care Tests', 'description': 'Subjects who received RTAT and Usual Care Tests (PCR) AND received official (non-indeterminate) test results.'}], 'classes': [{'categories': [{'measurements': [{'value': '92.307', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'Compare the congruence of test results between the rapid turnaround CT/NG test with the usual care test (send out PCR) in subjects that have both performed (Experimental Group).', 'unitOfMeasure': 'percentage of total RTAT + PCR patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Four patients received indeterminate results on either their RTAT or their Usual Care (PCR) tests.'}, {'type': 'SECONDARY', 'title': 'Healthcare Costs.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Turnaround Test', 'description': 'Subjects who received the RTAT'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects who were assigned to the usual care group only'}], 'timeFrame': '7 days', 'description': 'Evaluate the effect of utilizing a rapid PCR test on healthcare costs.', 'reportingStatus': 'POSTED', 'populationDescription': 'Heatlhcare cost data was not collected, thus could not be analyzed and reported.'}, {'type': 'SECONDARY', 'title': 'Average Score for Patient Satisfaction With Provider Explanation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Turnaround Test', 'description': 'Subjects who received the RTAT'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects who were assigned to the usual care group only'}], 'classes': [{'categories': [{'measurements': [{'value': '3.346153846', 'spread': '0.745241314', 'groupId': 'OG000'}, {'value': '3.24137931', 'spread': '0.872401137', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Evaluate patient satisfaction with provider\'s explanations for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their provider\'s explanations on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient counts for average satisfaction with provider explanation differ from total patient counts due to difficulty contacting patients for satisfaction surveys.'}, {'type': 'SECONDARY', 'title': 'Average Score for Patient Satisfaction With Treatment Effectiveness.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Turnaround Test', 'description': 'Subjects who received the RTAT'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects who were assigned to the usual care group only'}], 'classes': [{'categories': [{'measurements': [{'value': '3.153846154', 'spread': '0.731699812', 'groupId': 'OG000'}, {'value': '3.206896552', 'spread': '0.726012118', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Evaluate patient satisfaction with treatment effectiveness for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their treatment effectiveness on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient counts for average satisfaction with treatment effectiveness differ from total patient counts due to difficulty contacting patients for satisfaction surveys.'}, {'type': 'SECONDARY', 'title': 'Average Score for Patient Satisfaction With Overall Experience.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Turnaround Test', 'description': 'Subjects who received the RTAT'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects who were assigned to the usual care group only'}], 'classes': [{'categories': [{'measurements': [{'value': '3.346153846', 'spread': '0.561591146', 'groupId': 'OG000'}, {'value': '3.275862069', 'spread': '0.797162455', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Evaluate patient satisfaction with overall experience during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient counts for average satisfaction with overall experience differ from total patient counts due to difficulty contacting patients for satisfaction surveys.'}, {'type': 'SECONDARY', 'title': 'Number of Patients That Required Follow-up Care Within 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Turnaround Test', 'description': 'Subjects who received the RTAT'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects who were assigned to the usual care group only'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 days', 'description': 'Compare need for additional healthcare utilization between the groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Total number of participants for this analysis differ from total number of participants in overall study due to difficulty contacting some patients for data collection after initial hospital visit.'}, {'type': 'SECONDARY', 'title': 'Average Score for Patient Satisfaction With Wait Times During Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rapid Turnaround Test', 'description': 'Subjects who received the RTAT'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects who were assigned to the usual care group only'}], 'classes': [{'categories': [{'measurements': [{'value': '3.038461538', 'spread': '0.999230473', 'groupId': 'OG000'}, {'value': '2.931034483', 'spread': '0.923155864', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days', 'description': 'Evaluate patient satisfaction with wait times during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient counts for average satisfaction with wait times differ from total patient counts due to difficulty contacting patients for satisfaction surveys.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rapid Turnaround Test', 'description': 'Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.\n\nCepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.\n\nPolymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.\n\nPolymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rapid Turnaround Test', 'description': 'Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.\n\nCepheid Xpert CT/NG Rapid Turnaround Test: This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.\n\nPolymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.\n\nPolymerase chain reaction (PCR): This is the standard of care for diagnosis of a suspected sexually transmitted infection.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', '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': '30.3', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '55'}, {'value': '29', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '50'}, {'value': '29.6', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '55'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Presence of signs or symptoms of STIs', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All analyzed patients included'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2018-07-02', 'size': 164764, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-18T15:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Participants, investigators, and care providers will be masked to the experimental or control arm prior to enrollment in the study. Once the participant has been enrolled in the study, they will be randomized to either the control arm or the experimental arm. Once randomization has occurred, participants, care providers, and the investigators will know which group the participants are in.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, non-blinded, randomized clinical control trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'Low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-08', 'studyFirstSubmitDate': '2017-03-27', 'resultsFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2017-03-27', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-08', 'studyFirstPostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Treated With Antibiotics', 'timeFrame': '7 days', 'description': 'Evaluate the effect of a rapid turnaround CT/NG test compared to standard of care on antibiotic prescription for female patients with STI.'}], 'secondaryOutcomes': [{'measure': 'Length of Stay (Minutes)', 'timeFrame': '7 days', 'description': 'Evaluate the effect of utilizing a rapid turnaround CT/NG test on length of stay (minutes) in the Emergency Department.'}, {'measure': 'Percentage of Patients With Rapid Turnaround CT/NG (RPAT) Tests That Are CONSISTENT With Usual Care Test (PCR) in Subjects That Had Both Performed.', 'timeFrame': '7 days', 'description': 'Compare the congruence of test results between the rapid turnaround CT/NG test with the usual care test (send out PCR) in subjects that have both performed (Experimental Group).'}, {'measure': 'Healthcare Costs.', 'timeFrame': '7 days', 'description': 'Evaluate the effect of utilizing a rapid PCR test on healthcare costs.'}, {'measure': 'Average Score for Patient Satisfaction With Provider Explanation.', 'timeFrame': '7 days', 'description': 'Evaluate patient satisfaction with provider\'s explanations for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their provider\'s explanations on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."'}, {'measure': 'Average Score for Patient Satisfaction With Treatment Effectiveness.', 'timeFrame': '7 days', 'description': 'Evaluate patient satisfaction with treatment effectiveness for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their treatment effectiveness on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."'}, {'measure': 'Average Score for Patient Satisfaction With Overall Experience.', 'timeFrame': '7 days', 'description': 'Evaluate patient satisfaction with overall experience during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."'}, {'measure': 'Number of Patients That Required Follow-up Care Within 7 Days', 'timeFrame': '7 days', 'description': 'Compare need for additional healthcare utilization between the groups.'}, {'measure': 'Average Score for Patient Satisfaction With Wait Times During Visit.', 'timeFrame': '7 days', 'description': 'Evaluate patient satisfaction with wait times during visit for the 2 diagnostic groups. Patients were asked to rate their satisfaction with their wait times on a five point scale, with 0 being "not at all satisfied" and 4 being "very satisfied."'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Rapid turnaround test', 'RTAT', 'Gonorrhea', 'Chlamydia', 'STI'], 'conditions': ['Sexually Transmitted Infection', 'Gonorrhea Female', 'Chlamydia Females']}, 'referencesModule': {'references': [{'pmid': '25935930', 'type': 'BACKGROUND', 'citation': 'Brook G. The performance of non-NAAT point-of-care (POC) tests and rapid NAAT tests for chlamydia and gonorrhoea infections. An assessment of currently available assays. Sex Transm Infect. 2015 Dec;91(8):539-44. doi: 10.1136/sextrans-2014-051997. Epub 2015 May 2.'}, {'pmid': '24450867', 'type': 'BACKGROUND', 'citation': 'Gaydos CA. Review of use of a new rapid real-time PCR, the Cepheid GeneXpert(R) (Xpert) CT/NG assay, for Chlamydia trachomatis and Neisseria gonorrhoeae: results for patients while in a clinical setting. Expert Rev Mol Diagn. 2014 Mar;14(2):135-7. doi: 10.1586/14737159.2014.871495. Epub 2014 Jan 23.'}, {'pmid': '23467600', 'type': 'BACKGROUND', 'citation': 'Gaydos CA, Van Der Pol B, Jett-Goheen M, Barnes M, Quinn N, Clark C, Daniel GE, Dixon PB, Hook EW 3rd; CT/NG Study Group. Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2013 Jun;51(6):1666-72. doi: 10.1128/JCM.03461-12. Epub 2013 Mar 6.'}, {'pmid': '26119905', 'type': 'BACKGROUND', 'citation': 'Holley CE, Van Pham T, Mezzadra HM, Willis GC, Witting MD. Overtreatment of gonorrhea and chlamydial infections in 2 inner-city emergency departments. Am J Emerg Med. 2015 Sep;33(9):1265-8. doi: 10.1016/j.ajem.2015.06.009. Epub 2015 Jun 12.'}, {'pmid': '17342672', 'type': 'BACKGROUND', 'citation': 'Newman LM, Moran JS, Workowski KA. Update on the management of gonorrhea in adults in the United States. Clin Infect Dis. 2007 Apr 1;44 Suppl 3:S84-101. doi: 10.1086/511422.'}, {'pmid': '23554203', 'type': 'BACKGROUND', 'citation': 'Tabrizi SN, Unemo M, Golparian D, Twin J, Limnios AE, Lahra M, Guy R; TTANGO Investigators. Analytical evaluation of GeneXpert CT/NG, the first genetic point-of-care assay for simultaneous detection of Neisseria gonorrhoeae and Chlamydia trachomatis. J Clin Microbiol. 2013 Jun;51(6):1945-7. doi: 10.1128/JCM.00806-13. Epub 2013 Apr 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of utilizing a rapid turnaround CT/NG test on treatment of female patients in the emergency department or urgent care setting with possible STIs.', 'detailedDescription': "All females ages 18-55 presenting to the University of Maryland Medical Center Emergency Department or Urgent Care whose provider suspects sexually transmitted infection will be offered study enrollment and be randomly assigned to either the control or the experimental group. Both groups will have a urinalysis, a pregnancy test, a pelvic exam, and an endocervical sample collected, but the experimental group's urine will be used to run the rapid turnaround test (RTAT) instead of the standard PCR. Data will be collected regarding provider decision making, length of stay in the emergency department, patient satisfaction, clinician satisfaction, further healthcare sought by patient, and cost surrounding each treatment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participant eligibility is not based on self-representation of gender identity. All participants in this study will receive a pelvic exam in the emergency department as well as a cervical swab for diagnostic testing.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients age 18-55\n* Signs or symptoms consistent with sexually transmitted infection\n* Medical provider willing to consider the result of the rapid turnaround test in decision to treat for gonorrhea/chlamydia\n* Must have a urine specimen obtained and a pelvic exam performed as part of the anticipated standard of care evaluation\n* Provides informed consent\n\nExclusion Criteria:\n\n* Signs of systemic infection\n* Patient in whom the provider is unwilling to consider the result of the rapid turnaround test\n* Patient who reports being treated for either gonorrhea or chlamydia in the preceding 3 months\n* Patients undergoing evaluation for sexual assault\n* Patients that are known to be pregnant or express concern that they may be pregnant\n* Incarcerated patients\n* Students/Employees of the facility\n* Presence of any other condition(s) that the investigator feels makes the patient unsuitable for study inclusion.'}, 'identificationModule': {'nctId': 'NCT03098394', 'briefTitle': 'Use of a Rapid Test for Gonorrhea & Chlamydia for Women Presenting With Possible Sexually Transmitted Infections', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Use of a Rapid Turnaround Test for Gonorrhea & Chlamydia to Improve Treatment of Women Presenting With Possible Sexually Transmitted Infections', 'orgStudyIdInfo': {'id': 'HP-00072766'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapid Turnaround Test', 'description': 'Patients randomized to this arm will be tested for a sexually transmitted infection (STI) with both the rapid nucleic acid amplification test (NAAT) as well as the conventional polymerase chain reaction (PCR) test. The results from the rapid turnaround test will guide providers on treatment decisions for a possible STI. The results from the PCR test will be used to verify the results of the rapid turnaround test.', 'interventionNames': ['Device: Cepheid Xpert CT/NG Rapid Turnaround Test', 'Device: Polymerase chain reaction (PCR)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Care', 'description': 'Patients randomized to this arm will be tested for a sexually transmitted infection (STI) using the conventional PCR test. The results from the PCR test normally take approximately 48-72 hours and these patients will likely receive treatment based on the decision of the clinical provider. The results from the PCR test will be used to verify the decision of the clinical provider to treat or withhold treatment for a possible STI.', 'interventionNames': ['Device: Polymerase chain reaction (PCR)']}], 'interventions': [{'name': 'Cepheid Xpert CT/NG Rapid Turnaround Test', 'type': 'DEVICE', 'otherNames': ['GeneXpert'], 'description': 'This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.', 'armGroupLabels': ['Rapid Turnaround Test']}, {'name': 'Polymerase chain reaction (PCR)', 'type': 'DEVICE', 'otherNames': ['PCR'], 'description': 'This is the standard of care for diagnosis of a suspected sexually transmitted infection.', 'armGroupLabels': ['Rapid Turnaround Test', 'Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Systems', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Richard G Wilkerson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not plan on sharing any individual participant data with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Richard Gentry Wilkerson', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}