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Ignite Creation Date: 2025-12-24 @ 7:02 PM

Ignite Modification Date: 2025-12-30 @ 5:13 AM

Study NCT ID: NCT05584657

Status: COMPLETED

Last Update Posted: 2024-11-20

First Post: 2022-10-14

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014552', 'term': 'Urinary Tract Infections'}, {'id': 'D003556', 'term': 'Cystitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011339', 'term': 'Probenecid'}, {'id': 'C082897', 'term': 'sulopenem'}, {'id': 'D019980', 'term': 'Amoxicillin-Potassium Clavulanate Combination'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D019818', 'term': 'Clavulanic Acid'}, {'id': 'D002969', 'term': 'Clavulanic Acids'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'saronin@iterumtx.com', 'phone': '8606614035', 'title': 'Senior Vice President and Head of Clinical Development', 'organization': 'Iterum Therapeutics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'eventGroups': [{'id': 'EG000', 'title': 'Sulopenem Etzadroxil/Probenecid', 'description': 'Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days\n\nSulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days', 'otherNumAtRisk': 1107, 'deathsNumAtRisk': 1107, 'otherNumAffected': 198, 'seriousNumAtRisk': 1107, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Amoxicillin/Clavulanate', 'description': 'Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days\n\nAmoxicillin/clavulanate: Oral Augmentin twice daily for 5 days', 'otherNumAtRisk': 1107, 'deathsNumAtRisk': 1107, 'otherNumAffected': 118, 'seriousNumAtRisk': 1107, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhea', 'notes': 'Treatment-emergent Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1107, 'numEvents': 90, 'numAffected': 90}, {'groupId': 'EG001', 'numAtRisk': 1107, 'numEvents': 45, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Nausea', 'notes': 'Treatment-emergent nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1107, 'numEvents': 48, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 1107, 'numEvents': 48, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Headache', 'notes': 'Treatment-emergent Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1107, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1107, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vulvovaginal mycotic infection', 'notes': 'Treatment-emergent Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1107, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1107, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Vomiting', 'notes': 'Treatment-emergent Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1107, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1107, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'seriousEvents': [{'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1107, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1107, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1107, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1107, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1107, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1107, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulopenem Etzadroxil/Probenecid', 'description': 'Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days\n\nSulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days'}, {'id': 'OG001', 'title': 'Amoxicillin/Clavulanate', 'description': 'Amoxicillin/clavulanate PO twice daily for 5 days\n\nAmoxicillin/clavulanate: Oral Augmentin twice daily for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 12+/-1 day', 'description': 'Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiologic Modified Intent to Treat Population'}, {'type': 'PRIMARY', 'title': 'Overall Success Susceptible Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulopenem Etzadroxil/Probenecid', 'description': 'Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days\n\nSulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days'}, {'id': 'OG001', 'title': 'Amoxicillin/Clavulanate', 'description': 'Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days\n\nAmoxicillin/clavulanate: Oral Augmentin twice daily for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '296', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 12+/-1 day', 'description': 'Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiological Modified intent-to-treat Susceptible Population'}, {'type': 'SECONDARY', 'title': 'Clinical Success Modified Intent-to-treat Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1107', 'groupId': 'OG000'}, {'value': '1107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulopenem Etzadroxil/Probenecid', 'description': 'Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days\n\nSulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days'}, {'id': 'OG001', 'title': 'Amoxicillin/Clavulanate', 'description': 'Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days\n\nAmoxicillin/clavulanate: Oral Augmentin twice daily for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '851', 'groupId': 'OG000'}, {'value': '849', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 12+/-1 day', 'description': 'Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat Population'}, {'type': 'SECONDARY', 'title': 'Clinical Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulopenem Etzadroxil/Probenecid', 'description': 'Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days\n\nSulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days'}, {'id': 'OG001', 'title': 'Amoxicillin/Clavulanate', 'description': 'Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days\n\nAmoxicillin/clavulanate: Oral Augmentin twice daily for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '397', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 12+/-1 day', 'description': 'Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiological Modified Intent-to-treat Population'}, {'type': 'SECONDARY', 'title': 'Clinical Success Susceptible Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulopenem Etzadroxil/Probenecid', 'description': 'Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days\n\nSulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days'}, {'id': 'OG001', 'title': 'Amoxicillin/Clavulanate', 'description': 'Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days\n\nAmoxicillin/clavulanate: Oral Augmentin twice daily for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '371', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 12+/-1 day', 'description': 'Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiological Modified Intent-to-treat Susceptible Population'}, {'type': 'SECONDARY', 'title': 'Microbiologic Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'OG000'}, {'value': '468', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulopenem Etzadroxil/Probenecid', 'description': 'Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days\n\nSulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days'}, {'id': 'OG001', 'title': 'Amoxicillin/Clavulanate', 'description': 'Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days\n\nAmoxicillin/clavulanate: Oral Augmentin twice daily for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '390', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 12+/-1 day', 'description': 'Eradication of the Baseline Pathogen', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiological Modified Intent-to-treat Population'}, {'type': 'SECONDARY', 'title': 'Microbiologic Success Susceptible Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulopenem Etzadroxil/Probenecid', 'description': 'Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days\n\nSulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days'}, {'id': 'OG001', 'title': 'Amoxicillin/Clavulanate', 'description': 'Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days\n\nAmoxicillin/clavulanate: Oral Augmentin twice daily for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '361', 'groupId': 'OG000'}, {'value': '295', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 12+/-1 day', 'description': 'Microbiologic Success: Eradication of the Baseline Pathogen', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiological Modified Intent-to-treat Susceptible Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sulopenem Etzadroxil/Probenecid', 'description': 'Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days\n\nSulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days'}, {'id': 'FG001', 'title': 'Amoxicillin/Clavulanate', 'description': 'Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days\n\nAmoxicillin/clavulanate: Oral Augmentin twice daily for 5 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1111'}, {'groupId': 'FG001', 'numSubjects': '1111'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1057'}, {'groupId': 'FG001', 'numSubjects': '1063'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '48'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'BG000'}, {'value': '468', 'groupId': 'BG001'}, {'value': '990', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sulopenem Etzadroxil/Probenecid', 'description': 'Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days\n\nSulopenem etzadroxil/probenecid: Oral sulopenem twice daily for 5 days'}, {'id': 'BG001', 'title': 'Amoxicillin/Clavulanate', 'description': 'Amoxicillin/clavulanate 875 mg/125 mg PO twice daily for 5 days\n\nAmoxicillin/clavulanate: Oral Augmentin twice daily for 5 days'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.3', 'spread': '17.31', 'groupId': 'BG000'}, {'value': '48.6', 'spread': '17.18', 'groupId': 'BG001'}, {'value': '49.5', 'spread': '17.26', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '522', 'groupId': 'BG000'}, {'value': '468', 'groupId': 'BG001'}, {'value': '990', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '333', 'groupId': 'BG000'}, {'value': '296', 'groupId': 'BG001'}, {'value': '629', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '419', 'groupId': 'BG000'}, {'value': '370', 'groupId': 'BG001'}, {'value': '789', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '522', 'groupId': 'BG000'}, {'value': '468', 'groupId': 'BG001'}, {'value': '990', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Patients enrolled in the United States', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Microbiological modified intent-to-treat population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-05', 'size': 1068540, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-30T14:37', 'hasProtocol': True}, {'date': '2024-01-10', 'size': 768408, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-30T14:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2229}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT04682834', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2022-10-14', 'resultsFirstSubmitDate': '2024-10-30', 'studyFirstSubmitQcDate': '2022-10-14', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-30', 'studyFirstPostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Success', 'timeFrame': 'Day 12+/-1 day', 'description': 'Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)'}, {'measure': 'Overall Success Susceptible Population', 'timeFrame': 'Day 12+/-1 day', 'description': 'Clinical Success (resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms) AND Microbiologic success (eradication of the baseline pathogen)'}], 'secondaryOutcomes': [{'measure': 'Clinical Success Modified Intent-to-treat Population', 'timeFrame': 'Day 12+/-1 day', 'description': 'Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms'}, {'measure': 'Clinical Success', 'timeFrame': 'Day 12+/-1 day', 'description': 'Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms'}, {'measure': 'Clinical Success Susceptible Population', 'timeFrame': 'Day 12+/-1 day', 'description': 'Resolution of uncomplicated urinary tract infection (uUTI) symptoms present at study entry and no new symptoms'}, {'measure': 'Microbiologic Success', 'timeFrame': 'Day 12+/-1 day', 'description': 'Eradication of the Baseline Pathogen'}, {'measure': 'Microbiologic Success Susceptible Population', 'timeFrame': 'Day 12+/-1 day', 'description': 'Microbiologic Success: Eradication of the Baseline Pathogen'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Tract Infections', 'Cystitis']}, 'referencesModule': {'references': [{'pmid': '40552968', 'type': 'DERIVED', 'citation': 'Puttagunta S, Aronin SI, Gupta J, Das AF, Gupta K, Dunne MW. Sulopenem versus Amoxicillin/Clavulanate for the Treatment of Uncomplicated Urinary Tract Infection. NEJM Evid. 2025 Jul;4(7):EVIDoa2400414. doi: 10.1056/EVIDoa2400414. Epub 2025 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.', 'detailedDescription': 'IT001-310 is a Phase 3, randomized, multicenter, double-blind, double dummy, controlled study to compare oral sulopenem etzadroxil/probenecid (oral sulopenem) to oral amoxicillin/clavulanate for the treatment of adult female patients with uncomplicated urinary tract infection. Approximately 1966 adult women with uncomplicated urinary tract infection will be randomized in a 1:1 fashion to receive either oral sulopenem etzadroxil/probenecid or oral amoxicillin/clavulanate twice daily for 5 days. The primary outcome measure for efficacy evaluation will be the overall success (combined clinical and microbiologic success) on Day 12 (± 1 day)/Test of Cure (TOC).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients ≥18 years of age with ≥24 hours and ≤96 hours of urinary symptoms attributable to a UTI\n* Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning on micturition, suprapubic pain.\n* A mid-stream urine specimen with evidence of pyuria as defined by either a machine-read dipstick positive for leukocyte esterase OR at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine OR white blood cell count ≥10 cells/high-powered field (HPF) in the sediment of a spun urine\n\nExclusion Criteria:\n\n* Presence of signs and symptoms suggestive of acute pyelonephritis defined as: fever (temperature \\> 38° Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting\n* Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days\n* Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI, including analgesics (e.g., non-steroidal anti-inflammatory drugs, aspirin, paracetamol etc.), phenazopyridine, and cranberry products.\n* Any anatomical abnormality of the urinary tract, including surgically modified urinary tract anatomy, and obstructive uropathy due to nephrolithiasis, stricture, tumor, or fibrosis\n* Ongoing urinary retention\n* Neurogenic bladder\n* Current resident of a long-term care facility\n* Instrumentation of urinary tract in the previous 30 days\n* An indwelling urinary catheter, ureteral stent or other foreign material in the urinary tract\n* Any history of trauma to the pelvis or urinary tract\n* Receiving hemodialysis, hemofiltration, peritoneal dialysis, or had a renal transplant\n* History of allergy or hypersensitivity to carbapenems, β-lactams or probenecid, as formulated with their excipients'}, 'identificationModule': {'nctId': 'NCT05584657', 'acronym': 'REASSURE', 'briefTitle': 'Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women', 'organization': {'class': 'INDUSTRY', 'fullName': 'Iterum Therapeutics, International Limited'}, 'officialTitle': 'A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women', 'orgStudyIdInfo': {'id': 'IT001-310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sulopenem etzadroxil/probenecid', 'description': 'Sulopenem etzadroxil/probenecid 500 mg/500 mg PO twice daily for 5 days', 'interventionNames': ['Drug: Sulopenem etzadroxil/probenecid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amoxicillin/clavulanate', 'description': 'Amoxicillin/clavulanate PO twice daily for 5 days', 'interventionNames': ['Drug: Amoxicillin/clavulanate']}], 'interventions': [{'name': 'Sulopenem etzadroxil/probenecid', 'type': 'DRUG', 'otherNames': ['Oral sulopenem'], 'description': 'Oral sulopenem twice daily for 5 days', 'armGroupLabels': ['Sulopenem etzadroxil/probenecid']}, {'name': 'Amoxicillin/clavulanate', 'type': 'DRUG', 'otherNames': ['Augmentin'], 'description': 'Oral Augmentin twice daily for 5 days', 'armGroupLabels': ['Amoxicillin/clavulanate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35055', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Facility', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '36571', 'city': 'Saraland', 'state': 'Alabama', 'country': 'United States', 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