Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-03-28 @ 5:44 AM
Study NCT ID:
NCT02784704
Status:
COMPLETED
Last Update Posted:
2022-01-06
First Post:
2016-05-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of Eravacycline Compared With Meropenem in Complicated Intra-abdominal Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C571179', 'term': 'eravacycline'}, {'id': 'D000077731', 'term': 'Meropenem'}], 'ancestors': [{'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ljpcregulatory@ljpc.com', 'phone': '617-715-3600', 'title': 'Chief Development Officer', 'organization': 'La Jolla Pharmaceutical Company'}, 'certainAgreement': {'otherDetails': "Publications should include input from the PI, his/her colleagues, other PIs in the trial and the Sponsor's personnel; such input should be reflected in the authorship. Agreement of order of authors should be established before writing a manuscript. The PI interested in participating in writing the manuscript should contact the Sponsor. The PI shall not make any publication without the Sponsor's prior written approval, which may be withheld or granted by the Sponsor, in it's sole discretion.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '52 days', 'description': 'All serious adverse events by preferred term, Safety Population', 'eventGroups': [{'id': 'EG000', 'title': 'Eravacycline', 'description': 'Eravacycline 1 mg/kg q12h', 'otherNumAtRisk': 250, 'deathsNumAtRisk': 250, 'otherNumAffected': 29, 'seriousNumAtRisk': 250, 'deathsNumAffected': 4, 'seriousNumAffected': 15}, {'id': 'EG001', 'title': 'Meropenem', 'description': 'Meropenem 1 g q8h', 'otherNumAtRisk': 249, 'deathsNumAtRisk': 249, 'otherNumAffected': 8, 'seriousNumAtRisk': 249, 'deathsNumAffected': 1, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Infusion site phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Neuroendocrine tumor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ureteric rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gallbladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Intestinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Splenic hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pelvic fluid collection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Suture related complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Wound decomposition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 249, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '205', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eravacycline', 'description': 'Eravacycline 1.0mg/kg q12h'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Meropenem 1g q8h'}], 'classes': [{'categories': [{'title': 'Clinical Cure', 'measurements': [{'value': '177', 'groupId': 'OG000'}, {'value': '187', 'groupId': 'OG001'}]}, {'title': 'Clinical Failure', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Indeterminate/missing', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'TOC visit: 25-31 days after first dose of study drug', 'description': 'Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.\n\nClinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.\n\nIndeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiological Intent-to-Treat Population: all randomized subjects who have at least one baseline bacterial pathogen that causes cIAI and against which the investigational drug has in vitro antibacterial activity.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '249', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eravacycline', 'description': 'Eravacycline 1.0 mg/kg q12h'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Meropenem 1.0g q8h'}], 'classes': [{'categories': [{'title': 'Clinical Cure', 'measurements': [{'value': '231', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}, {'title': 'Clinical Failure', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Indeterminate/missing', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'TOC visit: 25-31 days after first dose of study drug', 'description': 'Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.\n\nClinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.\n\nIndeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population: all randomized subjects who receive any amount of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '225', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Eravacycline', 'description': 'Eravacycline 1.0 mg/kg q12h'}, {'id': 'OG001', 'title': 'Meropenem', 'description': 'Meropenem 1.0g q8h'}], 'classes': [{'categories': [{'title': 'Clinical Cure', 'measurements': [{'value': '218', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}, {'title': 'Clinical Failure', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'TOC visit: 25-31 days after first dose of study drug', 'description': 'Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.\n\nClinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinically Evaluable: all randomized subjects who meet key inclusion/exclusion criteria and follow other important components of the trial'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eravacycline', 'description': 'Eravacycline 1.0mg/kg q12h'}, {'id': 'FG001', 'title': 'Meropenem', 'description': 'Meropenem 1g q8h'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '250'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '249'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}, {'groupId': 'FG001', 'numSubjects': '241'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Subject Non Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects with a diagnosis of complicated intra-abdominal infection (cIAI) requiring surgery were recruited into this study. Subjects were recruited in 65 centers worldwide. The first subject enrolled on 13 October 2016 and the last subject completed on 19 May 2017.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Eravacycline', 'description': 'Eravacycline 1.0 mg/kg q12h'}, {'id': 'BG001', 'title': 'Meropenem', 'description': 'Meropenem 1 g q8h'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '180', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '354', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.1', 'spread': '17.69', 'groupId': 'BG000'}, {'value': '52.8', 'spread': '18.24', 'groupId': 'BG001'}, {'value': '52.4', 'spread': '17.931', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '268', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '239', 'groupId': 'BG000'}, {'value': '238', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '18', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '249', 'groupId': 'BG000'}, {'value': '249', 'groupId': 'BG001'}, {'value': '498', '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': 'Region of Enrollment', 'classes': [{'title': 'Latvia', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Georgia', 'categories': 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'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-03-20', 'size': 922338, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-17T14:12', 'hasProtocol': True}, {'date': '2017-07-12', 'size': 1942388, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-17T14:13', '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': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-16', 'studyFirstSubmitDate': '2016-05-23', 'resultsFirstSubmitDate': '2018-12-21', 'studyFirstSubmitQcDate': '2016-05-26', 'lastUpdatePostDateStruct': {'date': '2022-01-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-12', 'studyFirstPostDateStruct': {'date': '2016-05-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Microbiological Intent-to-treat (Micro-ITT) Population', 'timeFrame': 'TOC visit: 25-31 days after first dose of study drug', 'description': 'Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.\n\nClinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.\n\nIndeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the All-Treated (MITT) Population', 'timeFrame': 'TOC visit: 25-31 days after first dose of study drug', 'description': 'Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.\n\nClinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.\n\nIndeterminate/missing was defined as an outcome that was neither a clinical cure nor clinical failure, if the investigator did not complete an assessment, if a study visit was not conducted, or if the subject died for a cause unrelated to cIAI.'}, {'measure': 'Number of Participants With a Favorable Clinical Response at the Test-of-Cure (TOC) Visit in the Clinically Evaluable (CE) Population', 'timeFrame': 'TOC visit: 25-31 days after first dose of study drug', 'description': 'Clinical cure was defined as complete resolution or significant improvement of signs and symptoms of the index infection such that no additional antibacterial therapy, surgical, or radiological intervention was required.\n\nClinical failure was defined as death related to complicated intra-abdominal infection (cIAI), persistence of clinical symptoms of cIAI, unplanned surgical or percutaneous drainage procedures for complication or recurrence of cIAI, post-surgical wound infections requiring systemic antibiotics, or initiation of rescue antibacterial drug therapy for treatment of cIAI.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Complicated Intra-abdominal Infections', 'Complicated Appendicitis']}, 'referencesModule': {'references': [{'pmid': '30561562', 'type': 'RESULT', 'citation': 'Solomkin JS, Gardovskis J, Lawrence K, Montravers P, Sway A, Evans D, Tsai L. IGNITE4: Results of a Phase 3, Randomized, Multicenter, Prospective Trial of Eravacycline vs Meropenem in the Treatment of Complicated Intraabdominal Infections. Clin Infect Dis. 2019 Aug 30;69(6):921-929. doi: 10.1093/cid/ciy1029.'}, {'pmid': '31570004', 'type': 'DERIVED', 'citation': 'Solomkin JS, Sway A, Lawrence K, Olesky M, Izmailyan S, Tsai L. Eravacycline: a new treatment option for complicated intra-abdominal infections in the age of multidrug resistance. Future Microbiol. 2019 Oct;14:1293-1308. doi: 10.2217/fmb-2019-0135. Epub 2019 Oct 1.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=30561562', 'label': 'IGNITE4: Results of a Phase 3, Randomized, Multicenter, Prospective Trial of Eravacycline vs. Meropenem in the Treatment of Complicated Intra-Abdominal Infections'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics (PK) of eravacycline compared with meropenem in the treatment of complicated intra-abdominal infections (cIAIs).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participant hospitalized for cIAI\n* At least 18 years of age\n* Evidence of a systemic inflammatory response\n* Abdominal pain or flank pain (with or without rebound tenderness), or pain caused by cIAI that is referred to another anatomic area\n* Able to provide informed consent\n* If male: must agree to use an effective barrier method of contraception during the study and for 14 days following the last dose if sexually active with a female of childbearing potential\n* If female, not pregnant or nursing or, if of childbearing potential: either will commit to use at least two medically accepted, effective methods of birth control (for example, condom, oral contraceptive, indwelling intrauterine device, hormonal implant /patch, injections, approved cervical ring) during study drug dosing and for 14 days following last study drug dose or practicing sexual abstinence\n\nExclusion Criteria:\n\n* Unlikely to survive the 6-8 week study period\n* Creatinine clearance of ≤50 milliliter (mL)/minute\n* Presence or possible signs of significant hepatic disease\n* Immunocompromised condition, including known human immunodeficiency virus (HIV) positivity, transplant recipients, and hematological malignancy\n* History of moderate or severe hypersensitivity reactions to tetracyclines, carbapenems, β-lactam antibiotics, or to any of the excipients contained in the study drug formulations\n* Participation in any investigational drug or device study within 30 days prior to study entry\n* Known or suspected current central nervous system (CNS) disorder that may predispose to seizures or lower seizure threshold (for example, severe cerebral arteriosclerosis, epilepsy)\n* Antibiotic-related exclusions:\n\n 1. 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