Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT01119105
Status:
COMPLETED
Last Update Posted:
2020-11-17
First Post:
2010-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591018', 'term': 'lefamulin'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.schranz@nabriva.com', 'phone': '610-981-2842', 'title': 'Jennifer Schranz, M.D., Chief Medical Officer', 'organization': 'Nabriva Therapeutics'}, 'certainAgreement': {'otherDetails': "All data from the study is confidential information. Sponsor has the right to publish first. Thereafter, PI may publish data from the study, but PI must submit the publication to Sponsor for review at least 60 days prior to publication. Sponsor may remove any confidential and/or proprietary information. If Sponsor's publication is not submitted within 12 months after the study, or if Sponsor decides not to publish, PI may publish the data, subject to Sponsor's rights in the agreement.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events and serious adverse events were collected from the time of consent through 30 days following the last dose of study medication; approximately 35 to 44 days per participant.', 'description': 'Adverse events were reported for the ITT population (i.e. all patients who received at least one dose of study medication). Treatment-emergent adverse events, defined as adverse events that started on or after the first dose of study medication, are reported. Adverse events were recorded whether or not they were considered to be study drug related.', 'eventGroups': [{'id': 'EG000', 'title': 'BC-3781 Dose 100mg', 'description': 'BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 50, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'BC-3781 Dose 150mg', 'description': 'BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 48, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Vancomycin', 'description': 'Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 49, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Infusion Site Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Blood Creatine Phosphokinase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 15}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 9}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pruritus Generalized', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Accidental Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 70, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 66, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BC-3781 Dose 100mg', 'description': 'BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.'}, {'id': 'OG001', 'title': 'BC-3781 Dose 150mg', 'description': 'BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.'}, {'id': 'OG002', 'title': 'Vancomycin', 'description': 'Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.'}], 'classes': [{'categories': [{'title': 'Success', 'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}, {'title': 'Failure', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Test of Cure (TOC), 7 - 14 days post final treatment', 'description': "Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinically Evaluable Population: A subset of all randomized patients who met additional pre-defined criteria.'}, {'type': 'PRIMARY', 'title': 'Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BC-3781 Dose 100mg', 'description': 'BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.'}, {'id': 'OG001', 'title': 'BC-3781 Dose 150mg', 'description': 'BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.'}, {'id': 'OG002', 'title': 'Vancomycin', 'description': 'Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.'}], 'classes': [{'categories': [{'title': 'Success', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}, {'title': 'Failure', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Test of Cure (TOC), 7 - 14 days post final treatment', 'description': "Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population: A subset of the Intent-to Treat Population who had a documented Gram-positive pathogen from a blood culture or from a culture of the acute bacterial skin and skin structure infection at baseline.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BC-3781 Dose 100mg', 'description': 'BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.'}, {'id': 'FG001', 'title': 'BC-3781 Dose 150mg', 'description': 'BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.'}, {'id': 'FG002', 'title': 'Vancomycin', 'description': 'Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'study drug missed on 2 consecutive days', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '207', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'BC-3781 Dose 100mg', 'description': 'BC-3781: BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.'}, {'id': 'BG001', 'title': 'BC-3781 Dose 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'3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.7', 'spread': '13.07', 'groupId': 'BG000'}, {'value': '42.2', 'spread': '13.41', 'groupId': 'BG001'}, {'value': '40.4', 'spread': '13.70', 'groupId': 'BG002'}, {'value': '41.4', 'spread': '13.35', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '170', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '166', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetic Status', 'classes': [{'categories': [{'title': 'Diabetic', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}, {'title': 'Non-diabetic', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '164', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Smoking Status', 'classes': [{'categories': [{'title': 'Current Smoker', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '97', 'groupId': 'BG003'}]}, {'title': 'Past Smoker', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Non-Smoker', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '85', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 210}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'dispFirstSubmitDate': '2012-06-05', 'completionDateStruct': {'date': '2011-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-29', 'studyFirstSubmitDate': '2010-05-05', 'dispFirstSubmitQcDate': '2012-06-25', 'resultsFirstSubmitDate': '2020-10-05', 'studyFirstSubmitQcDate': '2010-05-06', 'dispFirstPostDateStruct': {'date': '2012-07-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-05', 'studyFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Response', 'timeFrame': 'Test of Cure (TOC), 7 - 14 days post final treatment', 'description': "Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required."}, {'measure': 'Clinical Response', 'timeFrame': 'Test of Cure (TOC), 7 - 14 days post final treatment', 'description': "Clinical Response of Success was defined as resolution of the subject's clinical signs and symptoms with no additional antimicrobial therapy required"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute bacterial skin and skin structure infection', 'bacteria'], 'conditions': ['Bacterial Infections', 'Infection']}, 'referencesModule': {'references': [{'pmid': '25348519', 'type': 'DERIVED', 'citation': 'Rubino CM, Xue B, Bhavnani SM, Prince WT, Ivezic-Schoenfeld Z, Wicha WW, Ambrose PG. Population pharmacokinetic analyses for BC-3781 using phase 2 data from patients with acute bacterial skin and skin structure infections. Antimicrob Agents Chemother. 2015 Jan;59(1):282-8. doi: 10.1128/AAC.02033-13. Epub 2014 Oct 27.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase II, multi-center, randomized, double-blind study comparing the safety and efficacy of two doses of BC-3781 versus vancomycin in patients with acute bacterial skin and skin structure infection.', 'detailedDescription': 'The purpose of the study is to determine the efficacy of 2 dose regimens of BC-3781 versus the licensed medicinal product vancomycin over 5 to 14 days. The population in this study will be patients with an acute bacterial skin and skin structure infection (ABSSSI) and they will receive treatment with one of two doses of BC-3781 or vancomycin, a standard treatment for this condition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients \\> 18\n* Documented acute bacterial skin and skin structure infection\n\nExclusion Criteria:\n\n* Uncomplicated skin and skin structure infection'}, 'identificationModule': {'nctId': 'NCT01119105', 'briefTitle': 'Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nabriva Therapeutics AG'}, 'officialTitle': 'A Phase II, Multi-center, Randomized, Double-blind Study Comparing the Safety and Efficacy of Two Doses of BC-3781 Versus Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection', 'orgStudyIdInfo': {'id': 'NAB-BC-3781-2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BC-3781 dose 100mg', 'interventionNames': ['Drug: BC-3781']}, {'type': 'EXPERIMENTAL', 'label': 'BC-3781 dose 150mg', 'interventionNames': ['Drug: BC-3781']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'BC-3781', 'type': 'DRUG', 'description': 'BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.', 'armGroupLabels': ['BC-3781 dose 100mg']}, {'name': 'BC-3781', 'type': 'DRUG', 'description': 'BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.', 'armGroupLabels': ['BC-3781 dose 150mg']}, {'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.', 'armGroupLabels': ['Vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'BC-3781 Study Center 002', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'BC-3781 Study Center 001', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'BC-3781 Study Center 003', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'BC-3781 Study Center 012', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'BC-3781 Study Center 018', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'BC-3781 Study Center 021', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70503', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'BC-3781 Study Center 023', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'BC-3781 Study Center 004', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '08244', 'city': 'Somers Point', 'state': 'New Jersey', 'country': 'United States', 'facility': 'BC-3781 Study Center 016', 'geoPoint': {'lat': 39.31762, 'lon': -74.5946}}], 'overallOfficials': [{'name': 'William T. Prince, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Nabriva Therapeutics AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nabriva Therapeutics AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}