Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-03-02 @ 8:05 AM
Study NCT ID:
NCT01811732
Status:
COMPLETED
Last Update Posted:
2017-09-27
First Post:
2013-03-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D002481', 'term': 'Cellulitis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C477891', 'term': 'delafloxacin'}, {'id': 'D014640', 'term': 'Vancomycin'}, {'id': 'D001398', 'term': 'Aztreonam'}, {'id': 'D005947', 'term': 'Glucose'}], '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'}, {'id': 'D008997', 'term': 'Monobactams'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@melinta.com', 'phone': '1-844-MELINTA (1-844-635-4682)', 'title': 'Sue Cammarata (Chief Medical Officer)', 'organization': 'Melinta Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'Melinta has the right to first publication of results, which would be made in conjunction with the PIs from all appropriate sites. Thereafter, PIs may publish results provided the PI submits the proposed publication to Melinta for review at least 60 days prior to the date of the proposed publication. Melinta may remove any information that is considered confidential and/or proprietary. If a publication is not submitted within 12 months of study conclusion, the PI may publish results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from the time the patient signed the ICF through the follow-up telephone contact 30 days after the last dose of study drug (up to 45 days).', 'description': 'AE data are only included for the safety population which included all patients in the ITT population who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Delafloxacin Plus Placebo', 'description': '300mg iv every 12 hours, for a minimum of 10 and up to a maximum of 28 doses\n\nDelafloxacin: Delafloxacin\n\nPlacebo: Placebo', 'otherNumAtRisk': 324, 'deathsNumAtRisk': 324, 'otherNumAffected': 91, 'seriousNumAtRisk': 324, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Vancomycin Plus Aztreonam + Placebo', 'description': 'Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses\n\nVancomycin: Vancomycin\n\nAztreonam: Aztreonam\n\nPlacebo: Placebo', 'otherNumAtRisk': 326, 'deathsNumAtRisk': 326, 'otherNumAffected': 111, 'seriousNumAtRisk': 326, 'deathsNumAffected': 1, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 25}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Skin bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Staphylococcal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Polysubstance dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Substance-induced mood disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Gastric ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Stab wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Soft tissue necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Cervical radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Peripheral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 324, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 326, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response at 48 to 72 Hours (FDA Primary Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delafloxacin Plus Placebo', 'description': '300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses\n\nDelafloxacin: Delafloxacin\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': 'Vancomycin Plus Aztreonam + Placebo', 'description': 'Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses\n\nVancomycin: Vancomycin\n\nAztreonam: Aztreonam\n\nPlacebo: Placebo'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}]}]}, {'title': 'Non-Responder', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Responder Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.6', 'ciLowerLimit': '-8.8', 'ciUpperLimit': '3.6', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'A 2-sided 95% confidence interval (CI) for noninferiority testing was computed based on the difference in sample rates for vancomycin + aztreonam and delafloxacin at the primary endpoint. If the upper limit (UL) of the CI was less than 0.10, delafloxacin would be considered noninferior to vancomycin + aztreonam.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 to 72 hours after starting treatment', 'description': 'A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had \\<20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delafloxacin Plus Placebo', 'description': '300mg iv every 12 hours, for a minimum of 10 and up to a maximum of 28 doses\n\nDelafloxacin: Delafloxacin\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': 'Vancomycin Plus Aztreonam + Placebo', 'description': 'Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses\n\nVancomycin: Vancomycin\n\nAztreonam: Aztreonam\n\nPlacebo: Placebo'}], 'classes': [{'title': 'Cure', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '166', 'groupId': 'OG001'}]}]}, {'title': 'Improved', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'Failure', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Study Day 14 +/- 1 day', 'description': 'A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.\n\nA sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Investigator Assessment at the Late Follow-up Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}, {'value': '329', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delafloxacin Plus Placebo', 'description': '300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses\n\nDelafloxacin: Delafloxacin\n\nPlacebo: Placebo'}, {'id': 'OG001', 'title': 'Vancomycin Plus Aztreonam + Placebo', 'description': 'Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses\n\nVancomycin: Vancomycin\n\nAztreonam: Aztreonam\n\nPlacebo: Placebo'}], 'classes': [{'categories': [{'title': 'Cure', 'measurements': [{'value': '233', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}, {'title': 'Improved', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}, {'title': 'Failure', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'Indeterminate/Missing', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Study Day 21 to 28', 'description': 'A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.\n\nA sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Delafloxacin Plus Placebo', 'description': '300 mg IV every 12 hours, for a minimum of 10 and up to a maximum of 28 doses\n\nDelafloxacin: Delafloxacin\n\nPlacebo: Placebo'}, {'id': 'FG001', 'title': 'Vancomycin Plus Aztreonam + Placebo', 'description': 'Vancomycin 15 mg/kg IV plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses\n\nVancomycin: Vancomycin\n\nAztreonam: Aztreonam\n\nPlacebo: Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '331'}, {'groupId': 'FG001', 'numSubjects': '329'}]}, {'type': 'COMPLETED', 'comment': 'Completed the Late Follow-Up (LFU) Visit', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '271'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '58'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-compliance with study drug/procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Insufficient venous access', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject incarcerated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Admitted to another facility', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Correct study drug not available on site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'BG000'}, {'value': '329', 'groupId': 'BG001'}, {'value': '660', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Delafloxacin + Placebo', 'description': '300mg iv every 12 hours for a minimum of 10 and up to a maximum of 28 doses\n\nDelafloxacin: Delafloxacin\n\nPlacebo: Placebo'}, {'id': 'BG001', 'title': 'Vancomycin Plus Aztreonam + Placebo', 'description': 'Vancomycin 15mg/kg iv plus two grams Aztreonam every 12 hours for a minimum of 10 and up to a maximum of 28 doses\n\nVancomycin: Vancomycin\n\nAztreonam: Aztreonam\n\nPlacebo: Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '13.91', 'groupId': 'BG000'}, {'value': '45.3', 'spread': '14.44', 'groupId': 'BG001'}, {'value': '45.8', 'spread': '14.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<= 65 years', 'categories': [{'measurements': [{'value': '309', 'groupId': 'BG000'}, {'value': '309', 'groupId': 'BG001'}, {'value': '618', 'groupId': 'BG002'}]}]}, {'title': '> 65 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': '> 75 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': 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'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '304', 'groupId': 'BG001'}, {'value': '601', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, 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[{'value': '113', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '238', 'groupId': 'BG002'}]}]}, {'title': '>= 25', 'categories': [{'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '422', 'groupId': 'BG002'}]}]}, {'title': '>= 30', 'categories': [{'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}]}, {'title': '>= 35', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Presence of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat (ITT) Population included all patients who were randomly assigned to treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 660}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'dispFirstSubmitDate': '2015-06-22', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-29', 'studyFirstSubmitDate': '2013-03-08', 'dispFirstSubmitQcDate': '2015-06-22', 'resultsFirstSubmitDate': '2017-07-25', 'studyFirstSubmitQcDate': '2013-03-14', 'dispFirstPostDateStruct': {'date': '2015-07-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-25', 'studyFirstPostDateStruct': {'date': '2013-03-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response at 48 to 72 Hours (FDA Primary Endpoint)', 'timeFrame': '48 to 72 hours after starting treatment', 'description': 'A patient was considered a responder if s/he had a ≥20% reduction in size of the area of erythema associated with the baseline ABSSSI, as determined by digital planimetry of the leading edge and had none of the reasons for clinical failure; a patient was considered a non-responder (failure) if s/he had \\<20% reduction in size of the area of erythema associated with the baseline ABSSSI as determined by digital planimetry of the leading edge, or had major intervention such as another antibiotic or surgical intervention or died within 74 hours after initiation of study drug.'}], 'secondaryOutcomes': [{'measure': 'Investigator Assessment at the Follow-up Visit (EMA Primary Endpoint)', 'timeFrame': 'Study Day 14 +/- 1 day', 'description': 'A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.\n\nA sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing).'}, {'measure': 'Investigator Assessment at the Late Follow-up Visit', 'timeFrame': 'Study Day 21 to 28', 'description': 'A patient was considered a Cure if all baseline signs and symptoms of ABSSSI had resolved; if some symptoms remained, but the patient was improved to the extent that no additional antibiotic treatment was necessary, the response was Improved. A patient was considered a Failure for any of the following reasons: nonstudy antibacterial drug therapy was required because of lack of efficacy after at least 4 doses of study drug or for a treatment-related AE; study antibacterial drug therapy was required for longer than 28 doses; and/or unplanned surgical intervention was needed after study entry except for limited bedside debridement and standard wound care. Improved and Indeterminate responses were considered failures in the primary analysis.\n\nA sensitivity analysis was also performed, in which the assigned responses were Success (Cure + Improved) or Failure (Failure + Indeterminate/Missing).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bacterial skin infection', 'skin infection', 'infection', 'skin', 'delafloxacin', 'vancomycin', 'aztreonam', 'MRSA bacteria', 'bacterial infection', 'Anti-Infective Agents', 'Anti-Bacterial Agents'], 'conditions': ['Skin and Subcutaneous Tissue Bacterial Infections']}, 'referencesModule': {'references': [{'pmid': '30349845', 'type': 'DERIVED', 'citation': 'Lodise T, Corey R, Hooper D, Cammarata S. Safety of Delafloxacin: Focus on Adverse Events of Special Interest. Open Forum Infect Dis. 2018 Sep 10;5(10):ofy220. doi: 10.1093/ofid/ofy220. eCollection 2018 Oct.'}, {'pmid': '29029278', 'type': 'DERIVED', 'citation': 'Pullman J, Gardovskis J, Farley B, Sun E, Quintas M, Lawrence L, Ling R, Cammarata S; PROCEED Study Group. Efficacy and safety of delafloxacin compared with vancomycin plus aztreonam for acute bacterial skin and skin structure infections: a Phase 3, double-blind, randomized study. J Antimicrob Chemother. 2017 Dec 1;72(12):3471-3480. doi: 10.1093/jac/dkx329.'}, {'pmid': '28630189', 'type': 'DERIVED', 'citation': 'McCurdy S, Lawrence L, Quintas M, Woosley L, Flamm R, Tseng C, Cammarata S. In Vitro Activity of Delafloxacin and Microbiological Response against Fluoroquinolone-Susceptible and Nonsusceptible Staphylococcus aureus Isolates from Two Phase 3 Studies of Acute Bacterial Skin and Skin Structure Infections. Antimicrob Agents Chemother. 2017 Aug 24;61(9):e00772-17. doi: 10.1128/AAC.00772-17. Print 2017 Sep.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the efficacy of delafloxacin patients with acute bacterial skin and soft tissue infections (ABSSSI).', 'detailedDescription': 'The efficacy and safety of delafloxacin, compared to that of vancomycin plus aztreonam, will be evaluated in a population of patients with acute bacterial skin and soft tissue infections (ABSSSI), including major cutaneous abscesses, wound infections, cellulitis/erysipelas, and burn-related infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult (≥ 18 years of age) men or women with a diagnosis of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) (cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection) with surrounding redness of a minimum surface area of 75 cm\\^2 and at least two signs of systemic infection\n* In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy, and the subject must be able and willing to comply with protocol requirements\n\nExclusion Criteria:\n\n* A medical history of significant hypersensitivity or allergic reaction to quinolones, beta-lactams, vancomycin, or vancomycin derivatives according to the judgment of the investigator\n* Women who are pregnant or lactating\n* Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response, including infection involving a prosthetic joint, human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, sustained shock, gangrene or gas gangrene; burns covering ≥10% of body surface area; severely impaired arterial blood supply to an extremity with an ABSSSI, deep vein thrombosis or superficial thrombophlebitis, and requiring either an amputation or multiple debridement procedures\n* Receipt of systemic antibiotic therapy in the 14 days before enrollment unless 1 of the following was documented:\n\n 1. Received ≥ 48 hours of antibiotic therapy for ABSSSI AND clinical progression is documented (i.e., not by patient history alone).\n 2. Recently (within 14 days) completed a treatment course with an antibacterial drug for an infection other than ABSSSI and the drug does not have activity against bacterial pathogens that cause ABSSSI.\n 3. Received only 1 dose of either a single, potentially effective, short-acting antimicrobial drug or drug regimen for ABSSSI.\n* Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study including severe cardiac disease, known history of liver disease, end-stage renal disease, malignancy, psychiatric disorder, ongoing treatment for seizures or untreated history of seizures, or life expectancy of \\<3 months"}, 'identificationModule': {'nctId': 'NCT01811732', 'briefTitle': 'Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Melinta Therapeutics, Inc.'}, 'officialTitle': 'A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure 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