Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-10 @ 9:41 AM
Study NCT ID:
NCT03148756
Status:
TERMINATED
Last Update Posted:
2022-04-25
First Post:
2017-05-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis
Sponsor:
Organization:
Raw JSON
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Due to the low number of participants enrolled at only 1 site, 0 participants are reported for SAEs due to the risk of identification of a person.', 'eventGroups': [{'id': 'EG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'title': 'Success', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 84', 'description': 'Clinical response was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. Failure was defined as: ongoing signs and symptoms considered by the investigator to be related to complicated bacteremia or IE requiring additional antibacterial therapy or unplanned valve replacement, recurrent bacteremia, death during the study period up to Day 84 or discontinuation of the study medication due to an adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. 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Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42', 'description': 'Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Day 84 Mortality in the Safety Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 84', 'description': 'Day 84 mortality was measured by the number of deaths up to Day 84.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all randomized participants who received at least 1 dose of study treatment. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 84', 'description': 'Clinical outcome was either success or failure/relapse. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42', 'description': 'Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 84', 'description': 'Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42', 'description': 'Clinical outcome was either success or failure. 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Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 84', 'description': 'Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42', 'description': 'Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 84', 'description': 'Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population included all randomized participants regardless of whether or not study treatment was received. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have an early termination visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 42', 'description': 'Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'OG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 84', 'description': 'Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'CE Population included all participants in the mITT Population (all in the ITT who received ≥1 dose of study treatment) who met criteria for clinical evaluability. No participants were enrolled in the Dalbavancin arm. Due to early termination of the study, 1 participant did not have clinical outcomes determined, but did have a termination visit.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'FG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.'}, {'id': 'BG001', 'title': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Due to the low number of participants enrolled at only 1 site, 0 participants are reported due to the risk of identification of a person.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-19', 'size': 14343751, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-08T11:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Study stopped due to business reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2018-08-04', 'completionDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2017-05-09', 'dispFirstSubmitQcDate': '2018-08-04', 'resultsFirstSubmitDate': '2018-08-08', 'studyFirstSubmitQcDate': '2017-05-09', 'dispFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-08', 'studyFirstPostDateStruct': {'date': '2017-05-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Clinical Response at Day 84 in the Intent-to Treat (ITT) Population', 'timeFrame': 'Day 84', 'description': 'Clinical response was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required. Failure was defined as: ongoing signs and symptoms considered by the investigator to be related to complicated bacteremia or IE requiring additional antibacterial therapy or unplanned valve replacement, recurrent bacteremia, death during the study period up to Day 84 or discontinuation of the study medication due to an adverse event.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Clinical Outcome of Success at Day 42 in the ITT Population', 'timeFrame': 'Day 42', 'description': 'Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.'}, {'measure': 'Percentage of Participants With Clinical Outcome of Success at Day 42 in the Clinically Evaluable (CE) Population', 'timeFrame': 'Day 42', 'description': 'Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.'}, {'measure': 'Number of Participants With Day 84 Mortality in the Safety Population', 'timeFrame': 'Day 84', 'description': 'Day 84 mortality was measured by the number of deaths up to Day 84.'}, {'measure': 'Percentage of Participants With Clinical Outcome of Success at Day 84 in the CE Population', 'timeFrame': 'Day 84', 'description': 'Clinical outcome was either success or failure/relapse. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.'}, {'measure': 'Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the ITT Population', 'timeFrame': 'Day 42', 'description': 'Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.'}, {'measure': 'Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the ITT Population', 'timeFrame': 'Day 84', 'description': 'Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.'}, {'measure': 'Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 42 in the CE Population', 'timeFrame': 'Day 42', 'description': 'Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.'}, {'measure': 'Percentage of Participants With Clinical Outcome of Success by Pathogen at Day 84 in the CE Population', 'timeFrame': 'Day 84', 'description': 'Clinical outcome was either success or failure. Success was defined as resolution of clinical signs and symptoms of complicated bacteremia or infective endocarditis (IE) such that no additional antibiotic therapy was required.'}, {'measure': 'Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the ITT Population', 'timeFrame': 'Day 42', 'description': 'Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.'}, {'measure': 'Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the ITT Population', 'timeFrame': 'Day 84', 'description': 'Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.'}, {'measure': 'Percentage of Participants With Microbiological Success by Pathogen at Day 42 in the CE Population', 'timeFrame': 'Day 42', 'description': 'Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.'}, {'measure': 'Percentage of Participants With Microbiological Success by Pathogen at Day 84 in the CE Population', 'timeFrame': 'Day 84', 'description': 'Microbiological outcome could be either microbiologic success or microbiologic failure. Microbiologic Success was defined as no further growth of baseline pathogen from blood cultures.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endocarditis', 'Bacteremia']}, 'descriptionModule': {'briefSummary': 'This study will compare dalbavancin to standard of care (SOC) antibiotic therapy for the completion of therapy in patients with complicated bacteremia or infective endocarditis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of complicated bacteremia or infective endocarditis\n* Gram-positive bacteremia at screening with methicillin-susceptible Staphylococcus aureus (MSSA), methicillin-resistant Staphylococcus aureus (MRSA) or Streptococci\n* Treatment with standard of care antibiotics for 72 hours (h) - 10 days\n* Defervescence for at least 24h and clearance of bacteremia from screening pathogen.\n\nExclusion Criteria:\n\n* Embolic events\n* History of prosthetic valve surgery, cardiac device or prosthetic joint\n* Left-sided endocarditis due to Staphylococcus aureus (S. aureus)\n* Large mobile vegetations (\\>10 mm) on mitral valves\n* Perivalvular abscess\n* Uncomplicated bacteremia due to S. aureus\n* Gram-negative bacteria or fungi in blood cultures\n* Heart failure associated with infective endocarditis \\[Left Ventricular Ejection Fraction (LVEF) \\<40%\\]\n* Intravascular material or removable infection source not intended to be removed within 4 days postrandomization\n* Planned valve replacement surgery within 3 days of randomization\n* Refractory shock, significant hepatic insufficiency or severe leukopenia \\[Absolute Neutrophil Count (ANC) \\< 500 cells/mm\\^3\\]\n* Known osteomyelitis\n* Hypersensitivity to dalbavancin or other drugs in glycopeptide class\n* Infection with enterococci, coagulase-negative staphylococci, or with organism not susceptible to dalbavancin or vancomycin\n* Immunosuppression/immune deficiency\n* Concomitant systemic antibacterial therapy for gram-positive infection other than that allowed in protocol\n* Pregnant or nursing females.'}, 'identificationModule': {'nctId': 'NCT03148756', 'briefTitle': 'Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Phase 2, Open-Label, Randomized, Multicenter Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Documented Infective Endocarditis', 'orgStudyIdInfo': {'id': 'DAL-MD-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dalbavancin', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.', 'interventionNames': ['Drug: Dalbavancin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.', 'interventionNames': ['Drug: Standard of Care']}], 'interventions': [{'name': 'Dalbavancin', 'type': 'DRUG', 'description': 'Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.', 'armGroupLabels': ['Dalbavancin']}, {'name': 'Standard of Care', 'type': 'DRUG', 'description': 'Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34982', 'city': 'Ft. Pierce', 'state': 'Florida', 'country': 'United States', 'facility': 'Midway Immunology and Research Center', 'geoPoint': {'lat': 27.44671, 'lon': -80.32561}}], 'overallOfficials': [{'name': 'Urania Rappo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}