Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT03959527
Status:
COMPLETED
Last Update Posted:
2025-10-08
First Post:
2019-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Zoliflodacin in Uncomplicated Gonorrhoea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}}}}, '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': 'C000599190', 'term': 'zoliflodacin'}, {'id': 'D002443', 'term': 'Ceftriaxone'}, {'id': 'D017963', 'term': 'Azithromycin'}], 'ancestors': [{'id': 'D002439', 'term': 'Cefotaxime'}, {'id': 'D002505', 'term': 'Cephacetrile'}, {'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aluckey@gardp.org', 'phone': '+41 22 559 05 39', 'title': 'Dr Alison Luckey', 'organization': 'GARDP'}, 'certainAgreement': {'otherDetails': 'The sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo for a further 90 days in order to enable the sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Relatively low representation of females in primary analysis set due to asymptomatic nature of NG in this population, non-specific symptoms and inclusion criteria (prior contraceptive use).\n\nRelatively low representation of adolescents in study and non in PK sub-study, due to challenges with obtaining parental consent primarily in this indication.'}}, 'adverseEventsModule': {'timeFrame': '30 days (+/- 3 days)', 'description': 'All adverse events (AE) that occurred between Day -1 to Day 30 are reported, irrespective of causality assessment. Any AE that occurs after the reporting period assessed as possibly related to the investigational treatment should also be reported.\n\nFor screening failure participants, AEs are reported up until the date the participant was determined to be a screening failure. Beyond that date, only serious or medically relevant protocol-related events will be followed-up.', 'eventGroups': [{'id': 'EG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration', 'otherNumAtRisk': 619, 'deathsNumAtRisk': 619, 'otherNumAffected': 162, 'seriousNumAtRisk': 619, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration', 'otherNumAtRisk': 308, 'deathsNumAtRisk': 308, 'otherNumAffected': 107, 'seriousNumAtRisk': 308, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 42, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 38, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 65, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 619, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 308, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '88.1', 'upperLimit': '93.3'}, {'value': '96.2', 'groupId': 'OG001', 'lowerLimit': '92.9', 'upperLimit': '98.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.31', 'ciLowerLimit': '1.38', 'ciUpperLimit': '8.65', 'estimateComment': '95% CI of the treatment difference of ceftriaxone+ azithromycin combination minus zoliflodacin', 'groupDescription': 'Point estimate for the treatment difference in proportion of ceftriaxone/azithromycin combination and zoliflodacin with microbiological cure and 2-sided 95% CI calculated by Newcombe score method.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A single oral 3 g dose of zoliflodacin would be considered as non-inferior to a combination of a single IM 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin if the upper bound of the 2-sided 95% CI for the microbiological cure rate of the combination therapy minus zoliflodacin was less than 12% (prespecified non-inferiority \\[NI\\] margin for the primary endpoint).'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 6 (+/- 2)', 'description': 'Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at test of cure visit in micro-ITT (urogenital) analysis set', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'micro-ITT (urogenital): all randomized participants who had a positive NG culture from the relevant anatomical site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin'}, {'type': 'SECONDARY', 'title': 'Safety of a Single Dose of Zoliflodacin Will be Assessed Compared to a Combination a Single Dose of Ceftriaxone and Azithromycin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '619', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'title': 'All AEs', 'categories': [{'measurements': [{'value': '287', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'Related AEs', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to treatment discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maximum severity CTCAE Grade 1 or Mild', 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}]}, {'title': 'Maximum severity CTCAE Grade 2 or Moderate', 'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}]}, {'title': 'Maximum severity CTCAE Grade 3 or Severe', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Maximum severity CTCAE Grade 4 or Life-Threatening', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Maximum severity CTCAE Grade 5 or Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30', 'description': 'Incidence, severity, causality and seriousness of treatment-emergent adverse events (including clinically significant abnormal laboratory values/procedures i.e., physical examination per protocol)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all randomized participants who received any part of trial treatment'}, {'type': 'SECONDARY', 'title': 'Microbiological Cure Rate of Pharyngeal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 6', 'description': 'Proportion of participants with microbiological cure as determined by NG culture at pharyngeal sites at test of cure visit in micro-ITT (Pharyngeal).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT (Pharyngeal) population: all randomized participants who had a positive NG culture from the pharyngeal site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin'}, {'type': 'SECONDARY', 'title': 'Microbiological Cure Rate of Rectal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 6', 'description': 'Proportion of participants with microbiological cure as determined by NG culture at rectal sites at test of cure visit in micro-ITT (Rectal).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-ITT (Rectal): all randomized participants who had a positive NG culture from the rectal site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin'}, {'type': 'SECONDARY', 'title': 'The Clinical Cure Rate in Male Participants After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '460', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '375', 'groupId': 'OG000'}, {'value': '194', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 6', 'description': 'Proportion of male at birth participants experiencing resolution of signs and symptoms of urogenital gonococcal infection that were present at enrolment, at test of cure visit in Clinical Cure Population.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinical Cure population: all participants assigned male at birth included in the Micro-ITT (urogenital) population and who had at least one sign or symptom of urethral gonorrhea at baseline.'}, {'type': 'SECONDARY', 'title': 'Microbiological Cure Rate Among Females, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 6', 'description': 'Proportion of female participants with microbiological cure, as determined by NG culture at cervical site of infection, at TOC in micro-ITT (Urogenital) population', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'micro-ITT (Urogenital): all randomized participants who had a positive NG culture from the urogenital site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin'}, {'type': 'SECONDARY', 'title': 'Microbiological Cure Rate Among Males, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '456', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '412', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 6', 'description': 'Proportion of male participants with microbiological cure as determined by NG culture at urethral site of infection at TOC visit, in micro-ITT population', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'micro-ITT (urogenital): all randomized participants who had a positive NG culture from the urogenital site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin'}, {'type': 'SECONDARY', 'title': 'Eradication of Urogenital NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '492', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '405', 'groupId': 'OG000'}, {'value': '190', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 6', 'description': 'Proportion of participants with a positive NG NAAT result from urethral or cervical sites at baseline and a negative NG NAAT result at test of cure visit in micro-ITT analysis set.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of those participants included in the micro-ITT (Urogenital) analysis set (i.e., all randomized participants who had a positive NG culture from the urogenital site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin) (N=744), a total of 725 had a positive NG NAAT result at baseline'}, {'type': 'SECONDARY', 'title': 'Eradication of Pharyngeal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 6', 'description': 'Proportion of participants with a positive NG NAAT at baseline from pharyngeal sites and a negative NG NAAT at test of cure visit in micro-ITT analysis set.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of those participants included in the micro-ITT (Pharyngeal) analysis set (N=81) (i.e., all randomized participants who had a positive NG culture from the pharyngeal site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin), a total of 69 had positive pharyngeal NG NAAT result'}, {'type': 'SECONDARY', 'title': 'Eradication of Rectal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 6', 'description': 'Proportion of participants with a positive NG NAAT from rectal sites at baseline and a negative NG NAAT at test of cure visit in micro-ITT analysis set.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of those participants included in the micro-ITT (Rectal) analysis set (N=114) (i.e., all randomized participants who had a positive NG culture from the rectal site at baseline and whose baseline AST result showed no pre-existing resistance to both ceftriaxone and azithromycin), a total of 103 had a positive NG NAAT result at baseline'}, {'type': 'SECONDARY', 'title': 'Arithmetic Mean Plasma Concentration of Zoliflodacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '580', 'spread': '830', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 min - 1 hour', 'description': 'Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following oral administration of single oral dose of zoliflodacin 3 g', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 23 participants included in the PK Population Set (all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained), quantifiable zoliflodacin concentrations were available for only 22 participants at this time point'}, {'type': 'SECONDARY', 'title': 'Arithmetic Mean Plasma Concentration of Zoliflodacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '14500', 'spread': '9610', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2-2.5 h', 'description': 'Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following a single oral dose administration of zoliflodacin 3 g', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Population Set (all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained).'}, {'type': 'SECONDARY', 'title': 'Arithmetic Mean Plasma Concentration of Zoliflodacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '32300', 'spread': '8630', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4.5 - 5h', 'description': 'Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose of zoliflodacin 3 g', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population will include all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.'}, {'type': 'SECONDARY', 'title': 'Arithmetic Mean Plasma Concentration of Zoliflodacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '19300', 'spread': '6000', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 -12 h', 'description': 'Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose zoliflodacin 3 g', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population will include all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.'}, {'type': 'SECONDARY', 'title': 'Arithmetic Mean Plasma Concentration of Zoliflodacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '3270', 'spread': '1560', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 - 36 h', 'description': 'Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose of zoliflodacin 3 g', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population will include all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Plasma PK Profile (Tlast) After a Single, Oral, 3 g Dose of Zoliflodacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '24.6', 'spread': '3.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 2', 'description': 'Geometric mean time to last (Tlast) plasma concentration above the lower limit of quantitation', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Plasma PK Profile(Tmax) After a Single, Oral, 3 g Dose of Zoliflodacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '4.83', 'spread': '41.0', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 2', 'description': 'Geometric mean time to maximum plasma concentration (Tmax) after a single, oral, 3 g dose of zoliflodacin', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Plasma PK Profile (Cmax) After a Single, Oral, 3 g Dose of Zoliflodacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '31800', 'spread': '27.3', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 2', 'description': 'Geometric mean maximum plasma concentration (Cmax) after a single, oral 3 g dose of zoliflodacin', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.'}, {'type': 'SECONDARY', 'title': 'Evaluation of the Plasma PK Profile After a Single, Oral, 3 g Dose of Zoliflodacin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '330000', 'spread': '26.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 2', 'description': 'Geometric mean plasma area under the concentration-time curve (AUC0-last) from time zero to the last concentration above lower level of quantification', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population: all participants randomized to the zoliflodacin group who consent to participate to the PK sub-trial and from whom at least one valid PK sample post treatment is obtained.'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '8'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0.06', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline (Day 1)', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Test of Cure Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.5'}, {'value': '0.06', 'groupId': 'OG001', 'lowerLimit': '0.002', 'upperLimit': '0.5'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to cefixime (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Test of Cure Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '0.015', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.03'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to cefixime (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '0.015', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.25'}, {'value': '0.015', 'groupId': 'OG001', 'lowerLimit': '0.002', 'upperLimit': '0.12'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to ceftriaxone (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Test of Cure Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '0.015', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.015'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to ceftriaxone (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.0005', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.002', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to ciprofloxacin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline (zoliflodacin arm only since no microbiological failures in comparator arm)', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Test of Cure Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.004', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '16'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '16'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to gentamicin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Test of Cure Visit.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to gentamicin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '64'}, {'value': '32', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '64'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to spectinomycin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Test of Cure Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '32'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to spectinomycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0.12', 'upperLimit': '4'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to tetracycline (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Test of Cure Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to tetracycline (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.008', 'upperLimit': '0.5'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.008', 'upperLimit': '0.25'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to zolflodacin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}, {'type': 'SECONDARY', 'title': 'Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Test of Cure Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'OG001', 'title': 'Ceftriaxone Plus Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'classes': [{'categories': [{'measurements': [{'value': '0.12', 'groupId': 'OG000', 'lowerLimit': '0.008', 'upperLimit': '0.25'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to zoliflodacin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants in urogenital Micro-ITT without missing data for the specified visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'FG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '621'}, {'groupId': 'FG001', 'numSubjects': '309'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '571'}, {'groupId': 'FG001', 'numSubjects': '285'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Did not meet eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'A total 1011 participants were screened, of which 81 were screen failure'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '621', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '930', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.\n\nzoliflodacin: Dose: 3g, oral administration'}, {'id': 'BG001', 'title': 'Ceftriaxone and Azithromycin Combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).\n\nceftriaxone: Dose: 500mg, Intra-Muscular (IM) administration\n\nazithromycin: Dose: 1g, oral administration'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.0', 'spread': '9.56', 'groupId': 'BG000'}, {'value': '29.2', 'spread': '9.13', 'groupId': 'BG001'}, {'value': '29.7', 'spread': '9.42', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '544', 'groupId': 'BG000'}, {'value': '271', 'groupId': 'BG001'}, {'value': '815', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '603', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '899', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '285', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '349', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '514', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '113', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '278', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '424', 'groupId': 'BG002'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '270', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Randomised population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-12', 'size': 1230140, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-28T09:00', 'hasProtocol': True}, {'date': '2023-09-14', 'size': 1049396, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-28T09:02', 'hasProtocol': False}, {'date': '2021-10-26', 'size': 377188, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-25T05:53', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single dose of Zoliflodacin or comparators combination in single dose: ceftriaxone and azithromycin'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1011}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2019-05-02', 'resultsFirstSubmitDate': '2024-06-28', 'studyFirstSubmitQcDate': '2019-05-20', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-07-25', 'studyFirstPostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiological Cure Rate for Zoliflodacin Compared to a Combination of a Single Dose of Ceftriaxone and Azithromycin.', 'timeFrame': 'Day 6 (+/- 2)', 'description': 'Proportion of participants with microbiological cure as determined by culture at urethral or cervical sites at test of cure visit in micro-ITT (urogenital) analysis set'}], 'secondaryOutcomes': [{'measure': 'Safety of a Single Dose of Zoliflodacin Will be Assessed Compared to a Combination a Single Dose of Ceftriaxone and Azithromycin.', 'timeFrame': 'Day 30', 'description': 'Incidence, severity, causality and seriousness of treatment-emergent adverse events (including clinically significant abnormal laboratory values/procedures i.e., physical examination per protocol)'}, {'measure': 'Microbiological Cure Rate of Pharyngeal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'timeFrame': 'Day 6', 'description': 'Proportion of participants with microbiological cure as determined by NG culture at pharyngeal sites at test of cure visit in micro-ITT (Pharyngeal).'}, {'measure': 'Microbiological Cure Rate of Rectal Gonorrhoea of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'timeFrame': 'Day 6', 'description': 'Proportion of participants with microbiological cure as determined by NG culture at rectal sites at test of cure visit in micro-ITT (Rectal).'}, {'measure': 'The Clinical Cure Rate in Male Participants After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'timeFrame': 'Day 6', 'description': 'Proportion of male at birth participants experiencing resolution of signs and symptoms of urogenital gonococcal infection that were present at enrolment, at test of cure visit in Clinical Cure Population.'}, {'measure': 'Microbiological Cure Rate Among Females, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin', 'timeFrame': 'Day 6', 'description': 'Proportion of female participants with microbiological cure, as determined by NG culture at cervical site of infection, at TOC in micro-ITT (Urogenital) population'}, {'measure': 'Microbiological Cure Rate Among Males, After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin', 'timeFrame': 'Day 6', 'description': 'Proportion of male participants with microbiological cure as determined by NG culture at urethral site of infection at TOC visit, in micro-ITT population'}, {'measure': 'Eradication of Urogenital NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'timeFrame': 'Day 6', 'description': 'Proportion of participants with a positive NG NAAT result from urethral or cervical sites at baseline and a negative NG NAAT result at test of cure visit in micro-ITT analysis set.'}, {'measure': 'Eradication of Pharyngeal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'timeFrame': 'Day 6', 'description': 'Proportion of participants with a positive NG NAAT at baseline from pharyngeal sites and a negative NG NAAT at test of cure visit in micro-ITT analysis set.'}, {'measure': 'Eradication of Rectal NG NAAT at TOC After Administration of a Single Dose of Zoliflodacin Compared to a Single Dose of Ceftriaxone and Azithromycin.', 'timeFrame': 'Day 6', 'description': 'Proportion of participants with a positive NG NAAT from rectal sites at baseline and a negative NG NAAT at test of cure visit in micro-ITT analysis set.'}, {'measure': 'Arithmetic Mean Plasma Concentration of Zoliflodacin', 'timeFrame': '15 min - 1 hour', 'description': 'Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following oral administration of single oral dose of zoliflodacin 3 g'}, {'measure': 'Arithmetic Mean Plasma Concentration of Zoliflodacin', 'timeFrame': '2-2.5 h', 'description': 'Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following a single oral dose administration of zoliflodacin 3 g'}, {'measure': 'Arithmetic Mean Plasma Concentration of Zoliflodacin', 'timeFrame': '4.5 - 5h', 'description': 'Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose of zoliflodacin 3 g'}, {'measure': 'Arithmetic Mean Plasma Concentration of Zoliflodacin', 'timeFrame': '10 -12 h', 'description': 'Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose zoliflodacin 3 g'}, {'measure': 'Arithmetic Mean Plasma Concentration of Zoliflodacin', 'timeFrame': '24 - 36 h', 'description': 'Arithmetic mean plasma concentration (ng/mL) of zoliflodacin following administration of a single oral dose of zoliflodacin 3 g'}, {'measure': 'Evaluation of the Plasma PK Profile (Tlast) After a Single, Oral, 3 g Dose of Zoliflodacin', 'timeFrame': 'Day 2', 'description': 'Geometric mean time to last (Tlast) plasma concentration above the lower limit of quantitation'}, {'measure': 'Evaluation of the Plasma PK Profile(Tmax) After a Single, Oral, 3 g Dose of Zoliflodacin', 'timeFrame': 'Day 2', 'description': 'Geometric mean time to maximum plasma concentration (Tmax) after a single, oral, 3 g dose of zoliflodacin'}, {'measure': 'Evaluation of the Plasma PK Profile (Cmax) After a Single, Oral, 3 g Dose of Zoliflodacin', 'timeFrame': 'Day 2', 'description': 'Geometric mean maximum plasma concentration (Cmax) after a single, oral 3 g dose of zoliflodacin'}, {'measure': 'Evaluation of the Plasma PK Profile After a Single, Oral, 3 g Dose of Zoliflodacin', 'timeFrame': 'Day 2', 'description': 'Geometric mean plasma area under the concentration-time curve (AUC0-last) from time zero to the last concentration above lower level of quantification'}, {'measure': 'Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Baseline (Day 1)', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline (Day 1)'}, {'measure': 'Antimicrobial Susceptibility (Azithromycin) Profile of NG Isolates Obtained at Test of Cure Visit.', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC'}, {'measure': 'Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Baseline', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to cefixime (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline'}, {'measure': 'Antimicrobial Susceptibility (Cefixime) Profile of NG Isolates Obtained at Test of Cure Visit.', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to cefixime (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC'}, {'measure': 'Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Baseline', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to ceftriaxone (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline'}, {'measure': 'Antimicrobial Susceptibility (Ceftriaxone) Profile of NG Isolates Obtained at Test of Cure Visit.', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to ceftriaxone (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC'}, {'measure': 'Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Baseline', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to ciprofloxacin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline (zoliflodacin arm only since no microbiological failures in comparator arm)'}, {'measure': 'Antimicrobial Susceptibility (Ciprofloxacin) Profile of NG Isolates Obtained at Test of Cure Visit', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to azithromycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC'}, {'measure': 'Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Baseline', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to gentamicin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline'}, {'measure': 'Antimicrobial Susceptibility (Gentamicin) Profile of NG Isolates Obtained at Test of Cure Visit.', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to gentamicin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC'}, {'measure': 'Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Baseline', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to spectinomycin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline'}, {'measure': 'Antimicrobial Susceptibility (Spectinomycin) Profile of NG Isolates Obtained at Test of Cure Visit', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to spectinomycin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC'}, {'measure': 'Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Baseline', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to tetracycline (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline'}, {'measure': 'Antimicrobial Susceptibility (Tetracycline) Profile of NG Isolates Obtained at Test of Cure Visit', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to tetracycline (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC'}, {'measure': 'Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Baseline', 'timeFrame': 'Day 1', 'description': 'Antimicrobial susceptibility to zolflodacin (MIC90) - profile of gonococcal strains isolated from urogenital site at baseline'}, {'measure': 'Antimicrobial Susceptibility (Zoliflodacin) Profile of NG Isolates Obtained at Test of Cure Visit', 'timeFrame': 'Day 6', 'description': 'Antimicrobial susceptibility to zoliflodacin (MIC90) - profile of gonococcal strains isolated from urogenital site at TOC'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gonorrhea']}, 'referencesModule': {'references': [{'pmid': '41391465', 'type': 'DERIVED', 'citation': "Luckey A, Balasegaram M, Barbee LA, Batteiger TA, Broadhurst H, Cohen SE, Delany-Moretlwe S, de Vries HJC, Dionne JA, Gill K, Kenyon C, Kittiyaowamarn R, Lewis D, Mueller JP, Naicker V, O'Brien S, O'Donnell JP, Phanuphak N, Spooner E, Srinivasan S, Taylor SN, Unemo M, Zwane Z, Hook EW 3rd; Zoliflodacin Phase 3 Study Group. Zoliflodacin versus ceftriaxone plus azithromycin for treatment of uncomplicated urogenital gonorrhoea: an international, randomised, controlled, open-label, phase 3, non-inferiority clinical trial. Lancet. 2025 Dec 11:S0140-6736(25)01953-1. doi: 10.1016/S0140-6736(25)01953-1. Online ahead of print."}, {'pmid': '38130409', 'type': 'DERIVED', 'citation': 'Jacobsson S, Golparian D, Oxelbark J, Kong FYS, Da Costa RMA, Franceschi F, Brown D, Louie A, Drusano G, Unemo M. Pharmacodynamics of zoliflodacin plus doxycycline combination therapy against Neisseria gonorrhoeae in a gonococcal hollow-fiber infection model. Front Pharmacol. 2023 Dec 7;14:1291885. doi: 10.3389/fphar.2023.1291885. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This trial is a multi-center, open label, randomized controlled, non-inferiority phase III trial evaluating the safety and efficacy of a 3 g oral dose of zoliflodacin compared to a combination of a single intra-muscular 500 mg dose of ceftriaxone and a single 1 g oral dose of azithromycin for the treatment of uncomplicated gonorrhoea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 12 years old (if enrolment of minors is in agreement with local regulations and Ethics guidance)\n2. Weight ≥ 35 kg\n3. Signs and symptoms consistent with urethral or cervical gonorrhoea OR Urethral or cervical uncomplicated gonorrhoea as determined by either a positive culture or NAAT or Gram stain or methylene blue test/gentian violet stain in the past 14 days prior to screening OR Unprotected sexual contact with an individual reported to be infected with NG in the past 14 days prior to screening (confirmation by a positive NAAT, Gram stain or methylene blue test/ gentian violet stain or culture)\n4. For females of child-bearing potential, a negative urine pregnancy test at screening\n5. For females of child bearing potential, use of highly effective contraception for at least 28 days prior to screening and during at least 28 days after treatment. Females on oral contraceptives must also use a barrier contraception method during participation in the study.\n6. For males with a female partner of child-bearing age, willingness to delay conception for 28 days after treatment\n7. Willingness to comply with trial protocol\n8. Willingness to undergo HIV testing\n9. Willingness to abstain from sexual intercourse or use condoms for vaginal, anal and oral sex until end of trial visit\n10. Willingness and ability to give written informed consent or be consented by a legal representative or provide assent and parental consent (for minors, as appropriate).\n\n Exclusion Criteria:\n11. Confirmed or suspected complicated or disseminated gonorrhoea\n12. Pregnant or breastfeeding women\n13. Known concomitant infection which would require immediate additional systemic antibiotics with activity against NG (e.g. CT infection)\n14. Use of any systemic or intravaginal antibiotics with activity against NG within 30 days prior to screening\n15. Use of systemic corticoid drugs or other immunosuppressive therapy within 30 days prior to screening\n16. Use of moderate or strong CYP3A4 inducers (e.g. efavirenz, rifampicin, carbamazepine, phenobarbital) within 30 days or five half-lives of the drug, whichever is greater, prior to screening\n17. Cytotoxic or radiation therapy within 30 days prior to screening\n18. Known chronic renal, hepatic, hematologic impairment or other condition interfering with the absorption, distribution or elimination of the drug based on medical history and physical examination\n19. History of urogenital sex-reassignment surgery\n20. Immunosuppression as evidenced by medical history, clinical examination or a recent (≤ 1 month) CD4 count \\<200 cells/μL\n21. Know clinically relevant cardiac pro-arrhythmic conditions such as cardiac arrhythmia, congenital or documented QT prolongation\n22. Known history of severe allergy to cephalosporin, penicillin, monobactams, carbapenems or macrolide antibiotics\n23. Known or suspected allergies or hypersensitivities to lidocaine, methylparaben, lactose or any of the components of the study drugs (refer to the zoliflodacin IB and SmPC for the comparators treatments)\n24. Receipt or planned receipt of an investigational product in a clinical trial within 30 days or five half-lives of the drug, whichever is greater, prior to screening until end of participation to this clinical trial\n25. History of alcohol or drug abuse within 12 months prior to screening which would compromise trial participation in the judgment of the investigator\n26. Severe medical or psychiatric condition which, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of trial results or affect the individual's ability to provide informed consent\n27. Individuals whom, in the judgement of the investigator, are unlikely or unable to comply with this trial protocol\n28. Previous randomisation in this clinical trial.\n29. Use of moderate or strong CYP3A4 inhibitors within 30 days or five half-lives of the drug, whichever is greater, prior to screening"}, 'identificationModule': {'nctId': 'NCT03959527', 'briefTitle': 'Zoliflodacin in Uncomplicated Gonorrhoea', 'organization': {'class': 'OTHER', 'fullName': 'Global Antibiotics Research and Development Partnership'}, 'officialTitle': 'A Multi-center, Randomized, Open-label, Non Inferiority Trial to Evaluate the Efficacy and Safety of a Single, Oral Dose of Zoliflodacin Compared to a Combination of a Single Intramuscular Dose of Ceftriaxone and a Single Oral Dose of Azithromycin in the Treatment of Patients With Uncomplicated Gonorrhoea', 'orgStudyIdInfo': {'id': 'STI_Zoli001'}, 'secondaryIdInfos': [{'id': '2019-000990-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zoliflodacin', 'description': 'Participant in this arm will receive a single dose of zoliflodacin.', 'interventionNames': ['Drug: zoliflodacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ceftriaxone and azithromycin combination', 'description': 'Participant in this arm will receive a single dose of comparators combination (ceftriaxone and azithromycin).', 'interventionNames': ['Drug: ceftriaxone', 'Drug: azithromycin']}], 'interventions': [{'name': 'zoliflodacin', 'type': 'DRUG', 'description': 'Dose: 3g, oral administration', 'armGroupLabels': ['zoliflodacin']}, {'name': 'ceftriaxone', 'type': 'DRUG', 'description': 'Dose: 500mg, Intra-Muscular (IM) administration', 'armGroupLabels': ['ceftriaxone and azithromycin combination']}, {'name': 'azithromycin', 'type': 'DRUG', 'description': 'Dose: 1g, oral administration', 'armGroupLabels': ['ceftriaxone and azithromycin combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Jefferson County Department of Health', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294-0006', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '94103', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco Department Of Public Health City Clinic', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Bell Flower Clinic', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Public Health - Seattle & King County STD Clinic', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '2000', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Institute of Tropical Medicine', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1018 WT', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Public Health Service (GGD) Amsterdam / STI Outpatient Clinic', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3660', 'city': 'Bothas Hill', 'country': 'South Africa', 'facility': "SAMRC Botha's Hill Clinical Research Site", 'geoPoint': {'lat': -29.75134, 'lon': 30.73975}}, {'zip': '7975', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Masiphumelele Research Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '0470', 'city': 'Elandsdoorn', 'country': 'South Africa', 'facility': 'Ndlovu Research Centre', 'geoPoint': {'lat': -25.28243, 'lon': 29.19378}}, {'zip': '2001', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Wits RHI', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '0152', 'city': 'Soshanguve', 'country': 'South Africa', 'facility': 'Setshaba Research Centre', 'geoPoint': {'lat': -25.47288, 'lon': 28.09919}}, {'zip': '4400', 'city': 'Tongaat', 'country': 'South Africa', 'facility': 'SAMRC Tongaat Clinical Research Site', 'geoPoint': {'lat': -29.57366, 'lon': 31.11552}}, {'zip': '10120', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Bangrak STI Center', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Institute of HIV Research and Innovation', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Silom Community Clinic', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Global Antibiotics Research and Development Partnership', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}