Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-10 @ 12:26 PM
Study NCT ID:
NCT02961751
Status:
COMPLETED
Last Update Posted:
2020-08-25
First Post:
2016-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006069', 'term': 'Gonorrhea'}], 'ancestors': [{'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': 'D007239', 'term': 'Infections'}, {'id': 'D015231', 'term': 'Sexually Transmitted Diseases, Bacterial'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jdklausner@mednet.ucla.edu', 'phone': '310-267-0409', 'title': 'Jeffrey D. Klausner, MD, MPH', 'organization': 'University of California, Los Angeles'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were not collected for this study.', 'description': "Ciprofloxacin has a well-established safety profile and has been prescribed to several millions of people in the US and worldwide as it was the CDC's recommended treatment regimen for uncomplicated gonorrhea from 1993 to 2007. Therefore, adverse event assessment was not required for this study.", 'eventGroups': [{'id': 'EG000', 'title': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percentage of Subjects Infected With Gyrase A (gyrA) Serine 91 Genotype of Neisseria Gonorrhoeae (N. Gonorrhoeae) With Microbiological Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5 through Day 10', 'description': 'Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for rectal/urogenital wild type N. gonorrhoeae at baseline.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Microbiologically Cured Subjects Who Had Urogenital Tract Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90.5', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5 through Day 10', 'description': 'Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the urogenital tract were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for urogenital wild type N. gonorrhoeae at baseline.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Microbiologically Cured Subjects Who Had Rectal Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '96', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5 through Day 10', 'description': 'Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the rectum were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for rectal wild type N. gonorrhoeae at baseline.'}, {'type': 'SECONDARY', 'title': 'The Percentage of Microbiologically Cured Subjects Who Had Throat Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '80.7', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 5 through Day 10', 'description': 'Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the throat were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The per protocol population was limited to subjects meeting all inclusion criteria and no exclusion criteria and who were positive for wild type N. gonorrhoeae of the throat at baseline.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects With Urethral Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each urethral sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \\< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was intention-to-treat.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects With Cervical Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each cervical sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \\< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was intention-to-treat.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects With Rectal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each rectal sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \\< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was intention-to-treat.'}, {'type': 'SECONDARY', 'title': 'The Number of Subjects With Pharyngeal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each pharyngeal sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \\< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population was intention-to-treat.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '196'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Not Eligible at Enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Sites/clinics recruited subjects from their existing patient population, patients that were sent by referral from other clinics, and walk-ins. 232 volunteers were screened to enroll 211 subjects between 13SEP2016 and 31DEC2018.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '211', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.9', 'spread': '8.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '190', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '62', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '148', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '211', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Rectal/Urogenital Wild-Type N. gonorrhoeae infection', 'classes': [{'categories': [{'measurements': [{'value': '109', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Urogenital Wild-Type N. gonorrhoeae infection', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Rectal Wild-Type N. gonorrhoeae infection', 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Pharyngeal Wild-Type N. gonorrhoeae infection', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-17', 'size': 447659, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-24T14:28', 'hasProtocol': True}, {'date': '2019-04-08', 'size': 777978, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-12-24T14:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12-04', 'completionDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-20', 'studyFirstSubmitDate': '2016-11-09', 'resultsFirstSubmitDate': '2019-12-24', 'studyFirstSubmitQcDate': '2016-11-09', 'lastUpdatePostDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-16', 'studyFirstPostDateStruct': {'date': '2016-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percentage of Subjects Infected With Gyrase A (gyrA) Serine 91 Genotype of Neisseria Gonorrhoeae (N. Gonorrhoeae) With Microbiological Cure', 'timeFrame': 'Day 5 through Day 10', 'description': 'Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline.'}], 'secondaryOutcomes': [{'measure': 'The Percentage of Microbiologically Cured Subjects Who Had Urogenital Tract Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae', 'timeFrame': 'Day 5 through Day 10', 'description': 'Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the urogenital tract were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline'}, {'measure': 'The Percentage of Microbiologically Cured Subjects Who Had Rectal Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae', 'timeFrame': 'Day 5 through Day 10', 'description': 'Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the rectum were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline'}, {'measure': 'The Percentage of Microbiologically Cured Subjects Who Had Throat Infection Caused by gyrA Serine 91 Genotype N. Gonorrhoeae', 'timeFrame': 'Day 5 through Day 10', 'description': 'Subjects infected with gyrase A (gyrA) serine 91 genotype of Neisseria gonorrhoeae (N. gonorrhoeae) at the throat were evaluated for microbiological cure at 5-10 days after treatment. Cure was defined as N. gonorrhoeae not detectable by culture from all anatomical sites that had detectable N. gonorrhoeae at baseline'}, {'measure': 'The Number of Subjects With Urethral Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae', 'timeFrame': 'Day 1', 'description': 'Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each urethral sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \\< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.'}, {'measure': 'The Number of Subjects With Cervical Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae', 'timeFrame': 'Day 1', 'description': 'Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each cervical sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \\< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.'}, {'measure': 'The Number of Subjects With Rectal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae', 'timeFrame': 'Day 1', 'description': 'Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each rectal sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \\< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.'}, {'measure': 'The Number of Subjects With Pharyngeal Infection of gyrA Serine 91 Genotype N. Gonorrhoeae Who Have Ciprofloxacin-susceptible N. Gonorrhoeae', 'timeFrame': 'Day 1', 'description': 'Ciprofloxacin susceptibility was determined via culture-based antimicrobial susceptibility testing of the gonococcal isolate from each pharyngeal sample with a positive N. gonorrhoeae culture at Visit 1. An infection was deemed susceptible to ciprofloxacin if the reported minimum inhibitory concentration for the isolate was \\< 1 mcg/ml. Detection of wild type gyrA was determined by the real-time PCR analysis of the gyrA gene from the swab taken at Visit 1.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ciprofloxacin-susceptibility', 'Efficacy', 'Gyrase A Assay', 'Neisseria gonorrhoeae'], 'conditions': ['Gonococcal Infection']}, 'referencesModule': {'references': [{'pmid': '32766725', 'type': 'DERIVED', 'citation': 'Klausner JD, Bristow CC, Soge OO, Shahkolahi A, Waymer T, Bolan RK, Philip SS, Asbel LE, Taylor SN, Mena LA, Goldstein DA, Powell JA, Wierzbicki MR, Morris SR. Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study. Clin Infect Dis. 2021 Jul 15;73(2):298-303. doi: 10.1093/cid/ciaa596.'}]}, 'descriptionModule': {'briefSummary': 'This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrase A (gyrA) serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time Polymerase Chain Reaction (PCR) assay. The study will enroll approximately 381 subjects to obtain an eligibility target of 257 subjects, per protocol, age 18 and older regardless of gender identification who are seeking care in Sexually Transmitted Disease (STD) clinics of up to eight of the participating sites in the United States. Subjects who have untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract identified by a positive culture or Nucleic Acid Amplification Test (NAAT) conducted at a prior visit will be offered enrollment in the study. They will receive one dose of directly observed ciprofloxacin 500 milligrams. Subjects not consenting to participate in the study will receive treatment per local standard of care. The duration of the study for each subject will be approximately 11 through 14 days. The primary objective of this study is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae infections with gyrA serine 91 genotype.', 'detailedDescription': 'This study is a multi-center, single-arm, open-label clinical study to assess the efficacy of one dose of ciprofloxacin given orally in subjects infected with untreated gyrase A (gyrA) serine 91 genotype Neisseria gonorrhoeae (N. gonorrhoeae) as determined by a real-time Polymerase Chain Reaction (PCR) assay. The study will enroll approximately 381 subjects to obtain an eligibility target of 257 subjects, per protocol, age 18 and older regardless of gender identification who are seeking care in Sexually Transmitted Disease (STD) clinics of up to eight of the participating sites in the United States. Subjects who have untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract identified by a positive culture or Nucleic Acid Amplification Test (NAAT) conducted at a prior visit will be offered enrollment in the study. They will receive one dose of directly observed ciprofloxacin 500 milligrams. Subjects not consenting to participate in the study will receive treatment per local standard of care. The duration of the study for each subject will be approximately 11 through 14 days. The primary objective of this study is to determine the efficacy of ciprofloxacin for treatment of uncomplicated N. gonorrhoeae infections with gyrA serine 91 genotype. The secondary objectives of the study are to 1) investigate the efficacy of ciprofloxacin for treatment of uncomplicated serine 91 gyrA N. gonorrhoeae infection by anatomic site and 2) to determine the sensitivity of the gyrA assay for detection of ciprofloxacin-susceptible N. gonorrhoeae infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able to give voluntary written informed consent before any study related procedure is performed.\n2. 18 years or older, on the day of enrollment.\n3. Untreated gyrA serine 91 genotype N. gonorrhoeae of the rectum, or male or female urogenital tract, as determined by the gyrA test assay on a specimen collected within 30 days of enrollment.\n\n \\*Subjects must have gyrA serine 91 genotype detected for N. gonorrhoeae from at least one non-pharyngeal site.\n4. Willing to abstain from sexual intercourse or use condoms during any sexual contact until the Test of Cure Visit (Visit 2, Day 5-10) is complete.\n5. Women of childbearing potential must have no vaginal intercourse 14 days before enrollment or use an effective birth control method for 30 days before enrollment and agree to continue through visit 2.\n\n \\*A woman is considered of childbearing potential unless post-menopausal (greater than 2 years) or surgically sterilized (tubal ligation greater than 1 year, bilateral oophorectomy, or hysterectomy).\n\n \\*\\*Acceptable birth control methods for the purposes of this study may include abstinence from intercourse with a male partner, monogamous relationship with vasectomized partner, male condoms with the use of applied spermicide, intrauterine devices, and licensed hormonal methods. A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1 percent per year) when used consistently and correctly.\n6. Able to swallow pills.\n7. Willing to comply with protocol requirements, including availability for follow-up for the duration of the study.\n8. Agree to avoid systemic or intravaginal antibiotics with activity against N. gonorrhoeae from enrollment through Visit 2 (Day 5-10). Topical and intravaginal antifungals are permitted.\n9. Agree to avoid magnesium/aluminum antacids, sucralfate, didanosine, or highly buffered drugs, up to 2 hours after receipt of study drug.\n\nExclusion Criteria:\n\n1. Known renal insufficiency from clinical history.\n2. Use of systemic or intravaginal antibiotics with potential activity against N. gonorrhoeae within 30 days prior to study drug administration.\n\n \\*Topical and intravaginal antifungals are permitted.\n3. Use of systemic corticosteroid drugs or other immunosuppressive therapy within 30 days prior to enrollment.\n4. Receipt or planned receipt of an investigational product in a clinical trial within 30 days prior to or 7 days after treatment administration.\n5. Pregnant or breastfeeding.\n6. Clinical diagnosis of pelvic inflammatory disease or genital ulcer.\n7. Confirmed or suspected complicated or systemic gonococcal infection, such as abdominal pain, testicular pain, epididymitis, orchitis, arthritis, or endocarditis.\n8. Receipt of magnesium/aluminum antacids, sucralfate, didanosine, or highly buffered drugs, within 6 hours before receipt of study drug.\n9. Mutant N. gonorrhoeae gyrA serine 91 genotype from any anatomic site, as determined by the gyrA test assay on a specimen collected within 30 days of enrollment.\n10. Known allergy or history of adverse reaction to ciprofloxacin.\n11. Known allergy to quinolones.\n12. Previous enrollment in this study.\n13. Medical condition or other factor that in the judgment of the investigator might affect ability to comply with procedures.'}, 'identificationModule': {'nctId': 'NCT02961751', 'briefTitle': 'Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Clinical Validation of a Molecular Test for Ciprofloxacin-Susceptibility in Neisseria Gonorrhoeae', 'orgStudyIdInfo': {'id': '15-0090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ciprofloxacin', 'description': 'One dose of directly-observed ciprofloxacin 500 mg administered orally. N=381', 'interventionNames': ['Drug: Ciprofloxacin']}], 'interventions': [{'name': 'Ciprofloxacin', 'type': 'DRUG', 'description': 'Directly observed treatment with a single dose of ciprofloxacin 500 mg orally with or without food.', 'armGroupLabels': ['Ciprofloxacin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AIDS Healthcare Foundation Wellness Center - Hollywood', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90028-6213', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Lesbian Gay Bisexual/Transgender Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92103-8208', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego - Antiviral Research Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego Health - Owen Clinic', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94103-4030', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Department of Public Health - San Francisco City Clinic', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '20005', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Whitman-Walker Health', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '39202', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi - Infectious Diseases', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Philadelphia Department of Public Health - Health Center 1', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}