Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2025-12-28 @ 12:35 PM
Study NCT ID:
NCT03445195
Status:
COMPLETED
Last Update Posted:
2020-01-22
First Post:
2018-02-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections
Sponsor:
Organization:
Raw JSON
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Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Enquiries@entasistx.com', 'phone': '781-810-8940', 'title': 'Chief Medical Officer', 'organization': 'Entasis Therapeutics'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '48 hours to day 1, day 1, day 2, day 3, day 4, day 5, day 6,Day 7 to 14/ EOT + 1 day, 7 days post-EOT +/- 1 day(TOC), 7 days post-TOC +/- 2 days (LFU)', 'eventGroups': [{'id': 'EG000', 'title': 'Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin', 'description': 'Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 8, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo + Imipenem/Cilastatin', 'description': 'Placebo: Matching 1g IV solution.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 3, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Overall Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin', 'description': 'Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.'}, {'id': 'OG001', 'title': 'Placebo + Imipenem/Cilastatin', 'description': 'Placebo: Matching 1g IV solution.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline through day 21', 'description': 'The primary efficacy endpoint for this study was the proportion of patients with an overall success (clinical cure and micro-biologic eradication) for the m-MITT (Micro-biologically Modified Intent-to-Treat) Population at the TOC Visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Cure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin', 'description': 'Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.'}, {'id': 'OG001', 'title': 'Placebo + Imipenem/Cilastatin', 'description': 'Placebo: Matching 1g IV solution.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.'}], 'classes': [{'title': 'MITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'm-MITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'CE population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'ME population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to day 21', 'description': 'Proportion of patients with a response of clinical cure for the MITT(modified intent to treat), m-MITT (microbiologically modified intent to treat), CE(clinically evaluable), and ME(microbiologically evaluable) populations at the TOC(test of cure) visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number analyzed for each population is different as the efficacy outcome is for the proportion of subjects with a clinical cure for each group.'}, {'type': 'SECONDARY', 'title': 'Microbiologic Eradication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin', 'description': 'Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.'}, {'id': 'OG001', 'title': 'Placebo + Imipenem/Cilastatin', 'description': 'Placebo: Matching 1g IV solution.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.'}], 'classes': [{'title': 'm-MITT population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'ME population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to day 21', 'description': 'Proportion of patients with a response of microbiologic eradication for the m-MITT(microbiologically modified intent to treat) and ME(microbiologically evaluable) populations at the TOC visit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population differs for each group because the efficacy endpoint is for specific populations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin', 'description': 'Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.'}, {'id': 'FG001', 'title': 'Placebo + Imipenem/Cilastatin', 'description': 'Placebo: Matching 1g IV solution.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin', 'description': 'Sulbactam-ETX2514: The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.'}, {'id': 'BG001', 'title': 'Placebo + Imipenem/Cilastatin', 'description': 'Placebo: Matching 1g IV solution.\n\nImipenem-cilastatin: All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.4', 'spread': '17.55', 'groupId': 'BG000'}, {'value': '54.9', 'spread': '15.92', 'groupId': 'BG001'}, {'value': '52.6', 'spread': '17.00', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '79', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '80', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI (Body Mass Index)', 'classes': [{'categories': [{'measurements': [{'value': '28.09', 'spread': '6.661', 'groupId': 'BG000'}, {'value': '28.63', 'spread': '5.856', 'groupId': 'BG001'}, {'value': '28.27', 'spread': '6.368', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '172.6', 'spread': '8.81', 'groupId': 'BG000'}, {'value': '173.1', 'spread': '8.44', 'groupId': 'BG001'}, {'value': '172.8', 'spread': '8.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '83.79', 'spread': '20.644', 'groupId': 'BG000'}, {'value': '85.76', 'spread': '17.929', 'groupId': 'BG001'}, {'value': '84.45', 'spread': '19.677', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Screening Creatinine Clearance', 'classes': [{'categories': [{'measurements': [{'value': '94.3', 'spread': '23.76', 'groupId': 'BG000'}, {'value': '91.7', 'spread': '18.19', 'groupId': 'BG001'}, {'value': '93.4', 'spread': '21.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Milliliters per minute', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-08-01', 'size': 3989057, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-10T10:37', 'hasProtocol': True}, {'date': '2018-04-26', 'size': 1782286, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-10T10:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-20', 'studyFirstSubmitDate': '2018-02-20', 'resultsFirstSubmitDate': '2019-05-14', 'studyFirstSubmitQcDate': '2018-02-20', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-14', 'studyFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Overall Success', 'timeFrame': 'From baseline through day 21', 'description': 'The primary efficacy endpoint for this study was the proportion of patients with an overall success (clinical cure and micro-biologic eradication) for the m-MITT (Micro-biologically Modified Intent-to-Treat) Population at the TOC Visit.'}], 'secondaryOutcomes': [{'measure': 'Clinical Cure', 'timeFrame': 'Baseline to day 21', 'description': 'Proportion of patients with a response of clinical cure for the MITT(modified intent to treat), m-MITT (microbiologically modified intent to treat), CE(clinically evaluable), and ME(microbiologically evaluable) populations at the TOC(test of cure) visit.'}, {'measure': 'Microbiologic Eradication', 'timeFrame': 'Baseline to day 21', 'description': 'Proportion of patients with a response of microbiologic eradication for the m-MITT(microbiologically modified intent to treat) and ME(microbiologically evaluable) populations at the TOC visit'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complicated Urinary Tract Infection', 'Acute Pyelonephritis']}, 'referencesModule': {'references': [{'pmid': '31843995', 'type': 'DERIVED', 'citation': "Sagan O, Yakubsevitch R, Yanev K, Fomkin R, Stone E, Hines D, O'Donnell J, Miller A, Isaacs R, Srinivasan S. Pharmacokinetics and Tolerability of Intravenous Sulbactam-Durlobactam with Imipenem-Cilastatin in Hospitalized Adults with Complicated Urinary Tract Infections, Including Acute Pyelonephritis. Antimicrob Agents Chemother. 2020 Feb 21;64(3):e01506-19. doi: 10.1128/AAC.01506-19. Print 2020 Feb 21."}]}, 'descriptionModule': {'briefSummary': 'This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with complicated urinary tract infections (cUTIs) who are otherwise relatively healthy.', 'detailedDescription': 'This study is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of IV ETX2514SUL in patients with cUTIs who are otherwise relatively healthy. Patients with Acute Pyelonephritis may also be enrolled. Approximately 80 patients will be randomized to receive either 1 g ETX2514/1 g sulbactam IV or matching placebo every 6 hours (q6h). All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A signed informed consent form (ICF). If a study patient is unable to provide informed consent due to their medical condition, the patient's legally authorized representative may consent on behalf of the study patient as permitted by local law and institutional Standard Operating Procedures.\n* Male or female, 18 to 90 years of age, inclusive.\n* Expectation, in the judgment of the Investigator, that the patient's cUTI would require initial hospitalization and treatment with IV antibiotics.\n* Documented or suspected cUTI or Acute pyelonephritis (AP).\n\nExclusion Criteria:\n\n* Gross hematuria requiring intervention other than administration of study drug or removal or exchange of a urinary catheter.\n* Known non-renal source of infection such as endocarditis, osteomyelitis, abscess, meningitis, or pneumonia diagnosed within 7 days prior to randomization that would interfere with evaluation of response to the study antibiotics.\n* Patient requires continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study.\n* Receipt of a single dose of a long-acting, potentially-effective systemic antibiotic with activity against Gram-negative uropathogens for more than 24 hours within the 72-hour window prior to randomization.\n* Requirement at time of randomization for any reason for additional systemic antimicrobial therapy (including antibacterial, antimycobacterial, or antifungal therapy) other than study drug, with the exception of a single oral dose of any antifungal treatment for vaginal candidiasis.\n* Likely to require the use of an antibiotic for cUTI or AP prophylaxis during the patient's participation in the study \\[from randomization through the Late Follow-up (LFU) Visit\\].\n* Any patients previously randomized in this study."}, 'identificationModule': {'nctId': 'NCT03445195', 'briefTitle': 'Evaluation of Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Entasis Therapeutics'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis', 'orgStudyIdInfo': {'id': 'CS2514-2017-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin', 'interventionNames': ['Drug: Sulbactam-ETX2514', 'Drug: Imipenem-cilastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Imipenem/Cilastatin', 'interventionNames': ['Drug: Placebo', 'Drug: Imipenem-cilastatin']}], 'interventions': [{'name': 'Sulbactam-ETX2514', 'type': 'DRUG', 'otherNames': ['ETX2514SUL'], 'description': 'The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.', 'armGroupLabels': ['Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching 1g IV solution.', 'armGroupLabels': ['Placebo + Imipenem/Cilastatin']}, {'name': 'Imipenem-cilastatin', 'type': 'DRUG', 'description': 'All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.', 'armGroupLabels': ['Placebo + Imipenem/Cilastatin', 'Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Universeity Multiprofile Hospital for Active Teatment', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'University Multiprofile Hospital for Active Teatment-Clinic of Nephrology', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1606', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Pirogov', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1632', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Multiprofile Hospital for Active Teatment (MHAT) and Emergency Medicine - Doverie', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}], 'overallOfficials': [{'name': 'Anibal Calmaggi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medpace, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Entasis Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}