Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-04 @ 8:46 PM
Study NCT ID:
NCT02813694
Status:
COMPLETED
Last Update Posted:
2019-10-23
First Post:
2016-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591018', 'term': 'lefamulin'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jennifer.schranz@nabriva.com', 'phone': '610 981 2842', 'title': 'Jennifer Schranz, M.D., Chief Medical Officer', 'organization': 'Nabriva Therapeutics US, Inc'}, '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 were recorded from the time of informed consent through the completion of the Test-of-Cure (TOC) Visit (i.e., 5-10 days after the last dose of study drug). Serious adverse events were recorded from the time of informed consent to the Late Follow-Up Visit (approximately 30 days after the first dose of study drug).', 'description': 'Adverse events are reported for randomized subjects who received at least one dose of study drug (Safety Population). Treatment-emergent adverse events, defined as events occurring after the first dose of study drug, are reported. Adverse events were recorded whether or not they were considered to be study drug related.', 'eventGroups': [{'id': 'EG000', 'title': 'Lefamulin', 'description': 'oral lefamulin, 600mg', 'otherNumAtRisk': 368, 'deathsNumAtRisk': 368, 'otherNumAffected': 61, 'seriousNumAtRisk': 368, 'deathsNumAffected': 5, 'seriousNumAffected': 17}, {'id': 'EG001', 'title': 'Moxifloxacin', 'description': 'oral moxifloxacin, 400mg', 'otherNumAtRisk': 368, 'deathsNumAtRisk': 368, 'otherNumAffected': 12, 'seriousNumAtRisk': 368, 'deathsNumAffected': 3, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Inguinal Hernia Strangulated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Lung Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia Bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Tuberculous Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hepatic Enzyme Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nuclear Magnetic Resonance Imaging Brain Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute Myeloid Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Renal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Small Cell Lung Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Squamous Cell Carcinoma of Lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Embolic Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 368, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 368, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Early Clinical Response (ECR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lefamulin', 'description': 'oral lefamulin, 600mg'}, {'id': 'OG001', 'title': 'Moxifloxacin', 'description': 'oral moxifloxacin, 400mg'}], 'classes': [{'categories': [{'title': 'Responder', 'measurements': [{'value': '336', 'groupId': 'OG000'}, {'value': '334', 'groupId': 'OG001'}]}, {'title': 'Non-responder', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-4.4', 'ciUpperLimit': '4.5', 'estimateComment': 'Difference in percentage of Responders for ECR (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'non-inferiority margin= 10%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '96 hours +/- 24 hours after first dose of study drug', 'description': 'ECR was defined as survival with improvement in at least 2 signs and symptoms of CABP (relative to baseline), no worsening of any CABP sign or symptom, and no use of concomitant antibiotics for the treatment of CABP through the ECR assessment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis Set: All randomized subjects'}, {'type': 'SECONDARY', 'title': "Investigator's Assessment of Clinical Response (IACR)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '368', 'groupId': 'OG000'}, {'value': '368', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lefamulin', 'description': 'oral lefamulin, 600mg'}, {'id': 'OG001', 'title': 'Moxifloxacin', 'description': 'oral moxifloxacin, 400mg'}], 'classes': [{'categories': [{'title': 'Success', 'measurements': [{'value': '322', 'groupId': 'OG000'}, {'value': '328', 'groupId': 'OG001'}]}, {'title': 'Failure', 'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-6.3', 'ciUpperLimit': '3.1', 'estimateComment': 'Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \\[Y vs. N\\] and PORT risk class \\[III vs. IV/V\\], using CMH stratum weights.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'non-inferiority margin = 10%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '3.3', 'estimateComment': 'Difference in percentage of Success for IACR at test of cure visit. Confidence interval computed using a continuity-corrected Z-test.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'non-inferiority margain = 10%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'IACR was assessed at the Test-of-Cure Visit; 5 to 10 days after last dose of study drug', 'description': "IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified ITT population: All randomized subjects who received any amount of study drug'}, {'type': 'SECONDARY', 'title': "Investigator's Assessment of Clinical Response (IACR)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lefamulin', 'description': 'oral lefamulin, 600mg'}, {'id': 'OG001', 'title': 'Moxifloxacin', 'description': 'oral moxifloxacin, 400mg'}], 'classes': [{'categories': [{'title': 'Success', 'measurements': [{'value': '296', 'groupId': 'OG000'}, {'value': '305', 'groupId': 'OG001'}]}, {'title': 'Failure', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '0.5', 'estimateComment': 'Difference in percentage of success for IACR at test of cure visit (Lefamulin - Moxifloxacin). CI computed via Miettinen-Nurminen method, adjusted for prior antibiotic use \\[Y vs. N\\]; PORT risk class \\[III vs. IV/V\\], using CMH stratum weights.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'non-inferiority margain = 10%'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-8.4', 'ciUpperLimit': '0.7', 'estimateComment': 'Difference in Percentage of Success for IACR at test of cure visit (Lefamulin - Moxifloxacin). Confidence interval computed using continuity-corrected Z-statistic.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'non-inferiority margin = 10%'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'IACR was assessed at the Test-of-Cure Visit; 5 to 10 days after last dose of study drug', 'description': "IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinically Evaluable population: Subset of ITT population having met additional pre-defined criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lefamulin', 'description': 'oral lefamulin, 600mg'}, {'id': 'FG001', 'title': 'Moxifloxacin', 'description': 'oral moxifloxacin, 400mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Intent to Treat Analysis Set', 'groupId': 'FG000', 'numSubjects': '370'}, {'comment': 'Intent to Treat Analysis Set', 'groupId': 'FG001', 'numSubjects': '368'}]}, {'type': 'COMPLETED', 'comment': 'Completed Study (Late Follow Up Assessment)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '353'}, {'comment': 'Completed Study (Late Follow Up Assessment)', 'groupId': 'FG001', 'numSubjects': '354'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Randomized- did not receive study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Patient hospitalized', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was designed to enroll adults with CABP for which oral antibacterial therapy was appropriate. Subjects with PORT score of II, III and IV were eligible. The first subject was randomized in August 2016 and the last subject was randomized in December 2017', 'preAssignmentDetails': 'Subjects who met inclusion criteria and did not meet exclusion criteria were randomly assigned to a treatment group. Administration of study drug was expected to occur as soon as possible after the diagnosis of CABP with all Screening/baseline assessments expected to be completed within 24 hours before the first dose of study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'BG000'}, {'value': '368', 'groupId': 'BG001'}, {'value': '738', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lefamulin', 'description': 'oral lefamulin, 600mg'}, {'id': 'BG001', 'title': 'Moxifloxacin', 'description': 'oral moxifloxacin, 400mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '16.4', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '16.2', 'groupId': 'BG001'}, {'value': '57.5', 'spread': '16.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '163', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '387', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '325', 'groupId': 'BG000'}, {'value': '330', 'groupId': 'BG001'}, {'value': '655', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '274', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '544', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Philippines', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 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{'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Renal Status', 'classes': [{'categories': [{'title': 'Severe impairment (CrCl <30 mL/min)', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Moderate impairment (CrCl 30 to <60 mL/min)', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Mild impairment (CrCl 60 to <90 mL/min)', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}]}, {'title': 'Normal function (CrCl >/= 90 mL/min)', 'measurements': [{'value': '190', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pneumonia Outcomes Research Team (PORT) Risk Class', 'classes': [{'categories': [{'title': 'I', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'II', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '372', 'groupId': 'BG002'}]}, {'title': 'III', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}, {'title': 'IV', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'V', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'PORT Risk Class is a clinical prediction rule used to calculate risk of morbidity and mortality among patients presenting with community-acquired pneumonia taking into consideration age, history of comorbid conditions, physical examination findings, and laboratory or radiographic results. PORT Risk Class I is a PORT score of 0-50, II is 51-70, III is 71-90, IV is 91-130 and V is \\>130 with higher risk class indicating higher risk of morbidity and mortality.', 'unitOfMeasure': 'Participants'}, {'title': 'CURB-65 Score', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '197', 'groupId': 'BG000'}, {'value': '196', 'groupId': 'BG001'}, {'value': '393', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}, {'title': '3', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '4', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '5', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'CURB-65 is a clinical tool used to predict mortality in patients with community acquired pneumonia. The risk of death at 30 days increases as the score increases; a score of 0 indicates the lowest risk of death and a score of 5 indicates the highest risk of death. Defined as confusion of new onset, BUN \\>19 mg/dL, respiratory rate ≥30 breaths/min, systolic blood pressure \\<90 mm Hg or diastolic blood pressure ≤60 mm Hg, and age ≥65 years.', 'unitOfMeasure': 'Participants'}, {'title': 'American Thoracic Society (ATS) Minor Severity Criteria', 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ATS minor criteria are used to indicate severe community acquired pneumonia and suggests the need for intensive care unit (ICU) level care. Defined as presence of 3 or more of the following 9 criteria at baseline: respiratory rate of 30 breaths/min or greater, oxygen saturation less than 90% or PaO2 less than 60mmHg, blood urea nitrogen level of 20mg/dL or greater, white blood cell count less than 4,000/mm3, confusion, multilobar infiltrates, platelet level less than 100,000 cells/mm3, temperature lower than 36 °C, or systolic blood pressure less than 90mmHg.', 'unitOfMeasure': 'Participants'}, {'title': 'Systemic inflammatory response syndrome (SIRS) Criteria', 'classes': [{'categories': [{'measurements': [{'value': '353', 'groupId': 'BG000'}, {'value': '342', 'groupId': 'BG001'}, {'value': '695', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'SIRS is used to define a clinical response to a nonspecific insult of either infectious or noninfectious origin. SIRS is defined as a subject meeting at least 2 or more of the following: Fever of more than 38C (100.4F) or less than 36C (96.8F); heart rate greater than 90 beats/min; respiratory rate greater than 20 breaths/min or PaCO2 less than 32 mm Hg; abnormal white blood cell count (greater than 12,000/microL or less than 4,000/microL or greater than 10% immature band forms)', 'unitOfMeasure': 'Participants'}, {'title': 'Bacteremic', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Received Single Dose Short-Acting Antibacterial within 72 hrs of Randomization', 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '72', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-07', 'size': 1282269, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-12T11:57', 'hasProtocol': False}, {'date': '2016-03-17', 'size': 1107145, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-12T13:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 738}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'dispFirstSubmitDate': '2018-11-09', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-22', 'studyFirstSubmitDate': '2016-06-20', 'dispFirstSubmitQcDate': '2018-11-09', 'resultsFirstSubmitDate': '2019-08-28', 'studyFirstSubmitQcDate': '2016-06-22', 'dispFirstPostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-22', 'studyFirstPostDateStruct': {'date': '2016-06-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Clinical Response (ECR)', 'timeFrame': '96 hours +/- 24 hours after first dose of study drug', 'description': 'ECR was defined as survival with improvement in at least 2 signs and symptoms of CABP (relative to baseline), no worsening of any CABP sign or symptom, and no use of concomitant antibiotics for the treatment of CABP through the ECR assessment'}], 'secondaryOutcomes': [{'measure': "Investigator's Assessment of Clinical Response (IACR)", 'timeFrame': 'IACR was assessed at the Test-of-Cure Visit; 5 to 10 days after last dose of study drug', 'description': "IACR was defined as resolution or improvement of a subject's clinical signs and symptoms such that no additional antibacterial therapy was administered for the treatment of the current episode of CABP"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pneumonia', 'CABP', 'CAP', 'Community acquired bacterial pneumonia'], 'conditions': ['Community Acquired Pneumonia']}, 'referencesModule': {'references': [{'pmid': '33964925', 'type': 'DERIVED', 'citation': 'File TM Jr, Alexander E, Goldberg L, Das AF, Sandrock C, Paukner S, Moran GJ. Lefamulin efficacy and safety in a pooled phase 3 clinical trial population with community-acquired bacterial pneumonia and common clinical comorbidities. BMC Pulm Med. 2021 May 8;21(1):154. doi: 10.1186/s12890-021-01472-z.'}, {'pmid': '31560372', 'type': 'DERIVED', 'citation': 'Alexander E, Goldberg L, Das AF, Moran GJ, Sandrock C, Gasink LB, Spera P, Sweeney C, Paukner S, Wicha WW, Gelone SP, Schranz J. Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults With Community-Acquired Bacterial Pneumonia: The LEAP 2 Randomized Clinical Trial. JAMA. 2019 Nov 5;322(17):1661-1671. doi: 10.1001/jama.2019.15468.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate community-acquired bacterial pneumonia', 'detailedDescription': "Lefamulin is a potent, semi-synthetic antibacterial belonging to a novel class known as the pleuromutilins. The oral dosage form of lefamulin is under investigation in this study. Lefamulin's in vitro antibacterial profile includes the most important bacterial pathogens causing respiratory tract infection (RTI). The antibacterial spectrum comprises S. pneumoniae, H. influenzae, M. catarrhalis, the atypical respiratory pathogens L. pneumophila, C. pneumoniae, and M. pneumoniae, S. aureus including MRSA and CA-MRSA, ß-haemolytic streptococci including S. pyogenes and S. agalactiae, and Enterococcus faecium including vancomycin-resistant enterococci (VRE). Moreover, as demonstrated in cross-resistance studies, lefamulin remains active against clinical isolates resistant to the following antimicrobial(s) (classes): macrolides, lincosamides, streptogramin B, oxazolidinones, tetracyclines, ß lactams, quinolones, trimethoprim-sulfametoxazole, mupirocin, and vancomycin."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nEach subject must:\n\n1. Be male or female at least 18 years of age.\n2. Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions.\n3. Have an acute illness (less than or equal to 7 days duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening):\n\n * Dyspnea.\n * New or increased cough.\n * Purulent sputum production.\n * Chest pain due to pneumonia.\n4. Have at least 2 of the following vital sign abnormalities:\n\n * Fever (body temperature \\> 38.0 °C (100.4 °F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature \\< 35.0 °C (95.0 °F) measured orally or equivalent temperature from an alternate body site).\n * Hypotension (systolic blood pressure \\< 90 mmHg).\n * Tachycardia (heart rate \\> 100 beats/min).\n * Tachypnea (respiratory rate \\> 20 breaths/min).\n5. Have at least 1 other clinical sign or laboratory finding of CABP:\n\n * Hypoxemia (i.e., O2 saturation \\< 90 % on room air or while receiving supplemental oxygen at subject's baseline requirement or PaO2 \\< 60 mmHg).\n * Auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness).\n * White blood cell (WBC) count \\> 10 000 cells/mm3 or \\< 4 500 cells/mm3 or \\>15 % immature neutrophils (bands) regardless of total WBC count.\n6. Have radiographically-documented pneumonia within 48 hours before enrollment (i.e., infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray or chest computed tomography scan consistent with acute bacterial pneumonia).\n7. Have a Pneumonia Outcomes Research Team (PORT) Risk Class of II, III, or IV and be an appropriate candidate for oral antibiotic therapy as treatment for the current episode of CABP.\n\nExclusion Criteria:\n\nEach subject must NOT:\n\n1. Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization.\n2. Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens.\n3. Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms. NOTE: Residence in an independent living facility is permitted.\n4. Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of the study drugs (e.g., MRSA, Pseudomonas aeruginosa, any pathogen of the Enterobacteriaceae Family) or attributable to etiologies other than community acquired bacterial pathogens (e.g., ventilator associated pneumonia, hospital acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other fungal pneumonia, viral or mycobacterial infection of the lung).\n5. Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis).\n6. Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions)."}, 'identificationModule': {'nctId': 'NCT02813694', 'acronym': 'LEAP2', 'briefTitle': 'Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nabriva Therapeutics AG'}, 'officialTitle': 'A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Oral Lefamulin (BC 3781) Versus Oral Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia', 'orgStudyIdInfo': {'id': 'NAB-BC-3781-3102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lefamulin', 'description': 'oral lefamulin, 600mg', 'interventionNames': ['Drug: lefamulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin', 'description': 'oral moxifloxacin, 400mg', 'interventionNames': ['Drug: Moxifloxacin']}], 'interventions': [{'name': 'lefamulin', 'type': 'DRUG', 'otherNames': ['BC-3781'], 'description': 'antibacterial agent', 'armGroupLabels': ['lefamulin']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'otherNames': ['Avelox'], 'description': 'antibacterial agent', 'armGroupLabels': ['Moxifloxacin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': '1080', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '93701', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Site 1065', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': '1078', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Site 1072', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Site 1070', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Sherman Oaks', 'state': 'California', 'country': 'United States', 'facility': '1079', 'geoPoint': {'lat': 34.15112, 'lon': -118.44925}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Site 1053', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '32713', 'city': 'DeBary', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 1064', 'geoPoint': {'lat': 28.88305, 'lon': -81.30868}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 1052', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': '1076', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '46360', 'city': 'Michigan City', 'state': 'Indiana', 'country': 'United States', 'facility': 'Site 1051', 'geoPoint': {'lat': 41.70754, 'lon': -86.89503}}, {'zip': '71457', 'city': 'Natchitoches', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Site 1057', 'geoPoint': {'lat': 31.76072, 'lon': -93.08627}}, {'zip': '02740', 'city': 'New Bedford', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Site 1073', 'geoPoint': {'lat': 41.63526, 'lon': -70.92701}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Site 1055', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48235', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Site 1062', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Site 1068', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Site 1058', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59701', 'city': 'Butte', 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