Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-01 @ 6:55 AM
Study NCT ID:
NCT03964493
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2019-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000619733', 'term': 'TNP-2092'}, {'id': 'D014640', 'term': 'Vancomycin'}], 'ancestors': [{'id': 'D006020', 'term': 'Glycopeptides'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zhenkun.ma@tennorx.com', 'phone': '+1(646) 775-1861', 'title': 'Zhenkun Ma, PhD / CEO', 'organization': 'TenNor Therapeutics Limited'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up.', 'description': 'Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 27, 'seriousNumAtRisk': 78, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Vancomycin', 'description': 'vancomycin 1 g intravenous every 12 hours\n\nVancomycin: Vancomycin 1g/vial', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 11, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'seriousEvents': [{'term': 'MRSA bacteremia and worsening cellulitis', 'notes': 'Participant 002-0071 (TNP-2092 group) had a severe serious adverse event (SAE) of staphylococcal infection (MRSA bacteremia and worsening cellulitis) on Day 2, considered unrelated to study treatment and the SAE recovered on Day 8.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'mental status changes', 'notes': 'Participant 002-0038 in the vancomycin group had a moderate SAE of mental status changes related to opioid overdose on Day 18. The SAE was considered unrelated to study treatment and the SAE recovered/resolved on Day 19.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}, {'term': 'left upper extremity abscess,dehydration', 'notes': 'Participant 003-0031 in the vancomycin group had 2 SAEs:\n\nA severe SAE of left upper extremity abscess on Day 4. A severe SAE of dehydration on Day 47.\n\nThe SAEs were considered unrelated to study drug.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (21.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'vancomycin 1 g intravenous every 12 hours\n\nVancomycin: Vancomycin 1g/vial'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Nonresponder', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 to 72 hours after the first dose of study treatment', 'description': 'Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (mITT) Population: all randomized participants.'}, {'type': 'PRIMARY', 'title': 'Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'vancomycin 1 g intravenous every 12 hours\n\nVancomycin: Vancomycin 1g/vial'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Nonresponder', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 to 72 hours after the first dose of study treatment', 'description': 'Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only'}, {'type': 'PRIMARY', 'title': 'Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'vancomycin 1 g intravenous every 12 hours\n\nVancomycin: Vancomycin 1g/vial'}], 'classes': [{'title': 'Responder', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Nonresponder', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Indeterminate', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 to 72 hours after the first dose of study treatment', 'description': 'Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants)'}, {'type': 'SECONDARY', 'title': 'Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'vancomycin 1 g intravenous every 12 hours\n\nVancomycin: Vancomycin 1g/vial'}], 'classes': [{'categories': [{'title': 'Success', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 to 14 days after the end of study treatment', 'description': 'At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only'}, {'type': 'SECONDARY', 'title': 'Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'vancomycin 1 g intravenous every 12 hours\n\nVancomycin: Vancomycin 1g/vial'}], 'classes': [{'categories': [{'title': 'Success', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '7 to 14 days after the end of study treatment', 'description': 'At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants)'}, {'type': 'SECONDARY', 'title': "Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population", 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'vancomycin 1 g intravenous every 12 hours\n\nVancomycin: Vancomycin 1g/vial'}], 'classes': [{'categories': [{'title': 'Success', 'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After a minimum of 7 days up to 14 days of study treatment', 'description': 'At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only'}, {'type': 'SECONDARY', 'title': "Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population", 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}, {'id': 'OG001', 'title': 'Vancomycin', 'description': 'vancomycin 1 g intravenous every 12 hours\n\nVancomycin: Vancomycin 1g/vial'}], 'classes': [{'categories': [{'title': 'Success', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Indeterminate', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After a minimum of 7 days up to 14 days of study treatment', 'description': 'At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants)'}, {'type': 'SECONDARY', 'title': 'AUC0-12h After First Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}], 'classes': [{'categories': [{'measurements': [{'value': '135000', 'spread': '38200', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 12 hours post-dose', 'description': 'Partial area under the concentration versus time curve from time zero to time 12 hours.', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that have sufficient plasma points for AUC 0-12h after first infusion analysis (26 Participants).'}, {'type': 'SECONDARY', 'title': 'AUC0-12h After Last Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}], 'classes': [{'categories': [{'measurements': [{'value': '159000', 'spread': '74200', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 12 hours post-dose', 'description': 'Partial area under the concentration versus time curve from time zero to time 12 hours', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that have sufficient plasma points for AUC 0-12h after last infusion analysis (39 Participants)'}, {'type': 'SECONDARY', 'title': 'Cmax After Last Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}], 'classes': [{'categories': [{'measurements': [{'value': '38500', 'spread': '13400', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion', 'description': 'Maximum observed concentration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that have sufficient plasma points for Cmax after last infusion analysis (58 Participants)'}, {'type': 'SECONDARY', 'title': 'Cmax After First Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}], 'classes': [{'categories': [{'measurements': [{'value': '37500', 'spread': '13500', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion', 'description': 'Maximum observed concentration', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that have sufficient plasma points for Cmax after first infusion analysis (68 Participants)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}, {'id': 'FG001', 'title': 'Vancomycin', 'description': 'vancomycin 1 g intravenous every 12 hours\n\nVancomycin: Vancomycin 1g/vial'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours\n\nTNP-2092: TNP-2092 100mg/vial'}, {'id': 'BG001', 'title': 'Vancomycin', 'description': 'vancomycin 1 g intravenous every 12 hours\n\nVancomycin: Vancomycin 1g/vial'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.4', 'spread': '11.72', 'groupId': 'BG000'}, {'value': '42.7', 'spread': '13.16', 'groupId': 'BG001'}, {'value': '41.9', 'spread': '12.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '71', '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': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '173.5', 'spread': '9.46', 'groupId': 'BG000'}, {'value': '170.5', 'spread': '8.32', 'groupId': 'BG001'}, {'value': '172.5', 'spread': '9.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'spread': '2.98', 'groupId': 'BG000'}, {'value': '24.8', 'spread': '3.47', 'groupId': 'BG001'}, {'value': '24.4', 'spread': '3.15', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '72.8', 'spread': '11.81', 'groupId': 'BG000'}, {'value': '72.7', 'spread': '14.43', 'groupId': 'BG001'}, {'value': '72.8', 'spread': '12.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-14', 'size': 4275646, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-09-13T03:58', 'hasProtocol': True}, {'date': '2019-08-19', 'size': 2455150, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-09-13T04:26', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'TNP-2092 300 mg intravenous every 12 hours vancomycin 1 g intravenous every 12 hours'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-20', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-08', 'studyFirstSubmitDate': '2019-04-30', 'resultsFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2019-05-24', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-08', 'studyFirstPostDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population', 'timeFrame': '48 to 72 hours after the first dose of study treatment', 'description': 'Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.'}, {'measure': 'Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population', 'timeFrame': '48 to 72 hours after the first dose of study treatment', 'description': 'Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.'}, {'measure': 'Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population', 'timeFrame': '48 to 72 hours after the first dose of study treatment', 'description': 'Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.'}], 'secondaryOutcomes': [{'measure': 'Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population', 'timeFrame': '7 to 14 days after the end of study treatment', 'description': 'At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).'}, {'measure': 'Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population', 'timeFrame': '7 to 14 days after the end of study treatment', 'description': 'At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).'}, {'measure': "Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population", 'timeFrame': 'After a minimum of 7 days up to 14 days of study treatment', 'description': 'At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).'}, {'measure': "Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population", 'timeFrame': 'After a minimum of 7 days up to 14 days of study treatment', 'description': 'At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).'}, {'measure': 'AUC0-12h After First Infusion', 'timeFrame': '0 to 12 hours post-dose', 'description': 'Partial area under the concentration versus time curve from time zero to time 12 hours.'}, {'measure': 'AUC0-12h After Last Infusion', 'timeFrame': '0 to 12 hours post-dose', 'description': 'Partial area under the concentration versus time curve from time zero to time 12 hours'}, {'measure': 'Cmax After Last Infusion', 'timeFrame': '57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion', 'description': 'Maximum observed concentration'}, {'measure': 'Cmax After First Infusion', 'timeFrame': '57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion', 'description': 'Maximum observed concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TNP-2092', 'ABSSSI', 'Safety', 'Efficacy'], 'conditions': ['Skin and Subcutaneous Tissue Bacterial Infections', 'Gram-Positive Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety, tolerability, pharmacokinetic characteristics and efficacy of TNP-2092 in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens.', 'detailedDescription': 'This Phase 2, double-blind, randomized, multicenter, parallel, controlled study is conducted to evaluate safety, tolerability, pharmacokinetics and efficacy of TNP-2092, and vancomycin in adults with ABSSSI suspected or confirmed to be caused by gram-positive pathogens. The duration of the treatment period is a minimum of 7 days and a maximum of 14 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects may be included in the study if they meet all of the following inclusion criteria:\n\n * Males or females, 18 years of age or older;\n * ABSSSI suspected or confirmed to be caused by gram-positive pathogens, including:\n * Cellulitis/erysipelas;\n * Wound infection;\n * Major cutaneous abscess;\n * Lesion with a minimum surface area of 75 cm2;\n * Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Subjects will be excluded from the study if any of the following exclusion criteria apply prior to randomization:\n\n * History or hypersensitivity or intolerability to any fluoroquinolone, rifamycin or glycopeptide classes;\n * ABSSSI suspected or confirmed to be caused by pathogens that are resistant to the glycopeptide class;\n * Prior administration of systemic antibacterial therapy within 96 hours before randomization;\n * ABSSSI with suspected or confirmed infection caused by gram-negative or anaerobic organisms;\n * ABSSSI with suspected or confirmed infection caused by fungal, mycobacterial, parasitic, or viral pathogens;\n * Evidence of significant hepatic, hematologic, or immunologic disease;\n * History or evidence of severe renal disease.'}, 'identificationModule': {'nctId': 'NCT03964493', 'acronym': 'P2_ABSSSI', 'briefTitle': 'TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'TenNor Therapeutics Inc.'}, 'officialTitle': 'Phase 2, Double-Blind, Randomized, Multicenter, Parallel, Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection in Adults', 'orgStudyIdInfo': {'id': 'PJI001-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TNP-2092', 'description': 'TNP-2092 300 mg intravenous every 12 hours', 'interventionNames': ['Drug: TNP-2092']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vancomycin', 'description': 'vancomycin 1 g intravenous every 12 hours', 'interventionNames': ['Drug: Vancomycin']}], 'interventions': [{'name': 'TNP-2092', 'type': 'DRUG', 'description': 'TNP-2092 100mg/vial', 'armGroupLabels': ['TNP-2092']}, {'name': 'Vancomycin', 'type': 'DRUG', 'description': 'Vancomycin 1g/vial', 'armGroupLabels': ['Vancomycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92120', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'eStudy Site', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'TenNor Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TenNor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TenNor Therapeutics Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}