Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-09 @ 2:27 AM
Study NCT ID:
NCT02426918
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2015-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Debio 1450 for Bacterial Skin Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000657127', 'term': 'afabicin'}, {'id': 'D000069349', 'term': 'Linezolid'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info-international@debiopharm.com', 'phone': '4121 321 01 11', 'title': 'Vice President Clinical Research & Development', 'organization': 'Debiopharm International S.A.'}, 'certainAgreement': {'otherDetails': 'Any publication or scientific communication related to this study can only take place once the agreement between the Sponsor and the Investigator has been reached.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '21 days after EOT (Day 33)', 'description': 'Safety population included all participants who received at least one dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Debio 1450 80 mg/120 mg BID', 'description': 'Debio 1450 80 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.', 'otherNumAtRisk': 110, 'otherNumAffected': 18, 'seriousNumAtRisk': 110, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Debio 1450 160 mg/240 mg BID', 'description': 'Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.', 'otherNumAtRisk': 107, 'otherNumAffected': 29, 'seriousNumAtRisk': 107, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Vancomycin/Linezolid BID', 'description': 'Vancomycin was administered intravenously BID at doses of 1 g or 15 mg/kg. After 2 doses of Vancomycin IV, the Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.', 'otherNumAtRisk': 107, 'otherNumAffected': 20, 'seriousNumAtRisk': 107, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 107, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 107, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Debio 1450 80 mg/120 mg BID', 'description': 'Debio 1450 80 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.'}, {'id': 'OG001', 'title': 'Debio 1450 160 mg/240 mg BID', 'description': 'Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.'}, {'id': 'OG002', 'title': 'Vancomycin/Linezolid BID', 'description': 'Vancomycin was administered intravenously BID at doses of 1 g or 15 mg/kg. After 2 doses of Vancomycin IV, the Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.6', 'groupId': 'OG000'}, {'value': '90.1', 'groupId': 'OG001'}, {'value': '91.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-11.42', 'ciUpperLimit': '3.00', 'groupDescription': 'Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \\[cellulitis, noncellulitis\\] according to a Mantel-Haenszel type risk difference estimator.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority for the low dose was confirmed if the upper bound of the CI was \\< 15% and if non-inferiority was confirmed for the high dose.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-8.32', 'ciUpperLimit': '8.38', 'groupDescription': 'Treatment difference estimates and 95% CIs are calculated accounting for the randomization strata infection type \\[cellulitis, noncellulitis\\] according to a Mantel-Haenszel type risk difference estimator.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority for the high dose was confirmed if the upper bound of the CI was \\< 15%.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 48 to 72 hours from randomization (Day 4)', 'description': 'ECRR was defined as the percentage of responders to treatment at 48 to 72 hours from randomization. Responders were the participants who showed greater than or equal to (≥) 20% reduction in area of the primary lesion involving erythema, edema, or induration of the primary ABSSSI lesion (as assessed by the ruler method) at 48 to 72 hours compared to baseline.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Microbiological Intent-to-Treat (mITT) population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Clinical Success Rate: Percentage of Participants Assessed by the Investigator as Responders at 48 to 72 Hours From Randomization, at End of Treatment (EOT) and Short-term Follow-up (STFU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Debio 1450 80 mg/120 mg BID', 'description': 'Debio 1450 80 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.'}, {'id': 'OG001', 'title': 'Debio 1450 160 mg/240 mg BID', 'description': 'Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.'}, {'id': 'OG002', 'title': 'Vancomycin/Linezolid BID', 'description': 'Vancomycin was administered intravenously BID at doses of 1 g or 15 mg/kg. After 2 doses of Vancomycin IV, the Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.'}], 'classes': [{'title': '48 to 72 hours after randomization', 'categories': [{'measurements': [{'value': '83.7', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}, {'value': '86.1', 'groupId': 'OG002'}]}]}, {'title': 'EOT', 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000'}, {'value': '87.9', 'groupId': 'OG001'}, {'value': '92.1', 'groupId': 'OG002'}]}]}, {'title': 'STFU', 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000'}, {'value': '83.5', 'groupId': 'OG001'}, {'value': '92.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)', 'description': 'The Investigator Assessment of Clinical Outcome (IACO) of treatment was assessed for each participant as success or failure at 48 to 72 hours after randomization at EOT and STFU visits. Clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms, or complications attributable to ABSSSI such that no further antibiotic therapy is required for treatment of original site of infection. Clinical failure was requirement for additional antibiotic therapy for treatment of the original site of infection or incision and drainage of ABSSSI site that was not both anticipated and completed within a 48- to 72-hour window following randomization, or unplanned major surgical intervention required due to failure of study medication or development of osteomyelitis after baseline. Participants who met both success criteria and none of failure criteria were considered as a clinical success for IACO.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Clinical Success Rate: Percentage of Participants Assessed by the Sponsor as Responders After 7 to 10 Days of Treatment at EOT and STFU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Debio 1450 80 mg/120 mg BID', 'description': 'Debio 1450 80 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.'}, {'id': 'OG001', 'title': 'Debio 1450 160 mg/240 mg BID', 'description': 'Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.'}, {'id': 'OG002', 'title': 'Vancomycin/Linezolid BID', 'description': 'Vancomycin was administered intravenously BID at doses of 1 g or 15 mg/kg. After 2 doses of Vancomycin IV, the Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.'}], 'classes': [{'title': 'EOT', 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000'}, {'value': '86.8', 'groupId': 'OG001'}, {'value': '90.1', 'groupId': 'OG002'}]}]}, {'title': 'STFU', 'categories': [{'measurements': [{'value': '81.5', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}, {'value': '90.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'EOT (Day 12) and STFU (Day 19)', 'description': "The Sponsor's Assessment of Clinical Outcome was obtained at EOT and STFU visits based on IACO and additional criteria. Sponsor assessed participants as clinical failure if they required non-study or rescue antibiotics due to lack of efficacy after at least 48 hours from randomization or experienced drug-related serious adverse events (SAEs) or discontinuation of study medication for drug-related AEs or required antibiotic therapy for longer than 10 days or had the need for unplanned surgical intervention \\>48 hours after randomization. As per IACO, clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms or complications. Clinical failure was requirement for additional antibiotic therapy or incision and drainage of ABSSSI site or unplanned major surgical intervention or development of osteomyelitis.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Composite Assessment of Clinical Outcome (CACO) of Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Debio 1450 80 mg/120 mg BID', 'description': 'Debio 1450 80 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.'}, {'id': 'OG001', 'title': 'Debio 1450 160 mg/240 mg BID', 'description': 'Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.'}, {'id': 'OG002', 'title': 'Vancomycin/Linezolid BID', 'description': 'Vancomycin was administered intravenously BID at doses of 1 g or 15 mg/kg. After 2 doses of Vancomycin IV, the Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.7', 'groupId': 'OG000'}, {'value': '81.3', 'groupId': 'OG001'}, {'value': '88.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 to 72 hours after randomization (Day 4) and STFU (Day 19)', 'description': 'CACO of treatment was determined as a combined outcome of early response to treatment (at 48 to 72 hours from randomization) and IACO at the STFU visit. Participants had a CACO of success if they met both of the following criteria: An early response to treatment (at 48 to 72 hours from randomization) (ECR = responder) and a clinical outcome of success at the STFU visit (7 to 14 days after EOT) based on IACO (IACO = success).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Showed Microbiological Evidence of Cure 48 to 72 Hours From Randomization, EOT, and STFU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Debio 1450 80 mg/120 mg BID', 'description': 'Debio 1450 80 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.'}, {'id': 'OG001', 'title': 'Debio 1450 160 mg/240 mg BID', 'description': 'Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.'}, {'id': 'OG002', 'title': 'Vancomycin/Linezolid BID', 'description': 'Vancomycin was administered intravenously BID at doses of 1 g or 15 mg/kg. After 2 doses of Vancomycin IV, the Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.'}], 'classes': [{'title': '48 to 72 hours after randomization', 'categories': [{'measurements': [{'value': '72.8', 'groupId': 'OG000'}, {'value': '69.2', 'groupId': 'OG001'}, {'value': '75.2', 'groupId': 'OG002'}]}]}, {'title': 'EOT', 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000'}, {'value': '86.8', 'groupId': 'OG001'}, {'value': '91.1', 'groupId': 'OG002'}]}]}, {'title': 'STFU', 'categories': [{'measurements': [{'value': '84.8', 'groupId': 'OG000'}, {'value': '83.5', 'groupId': 'OG001'}, {'value': '91.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)', 'description': "The microbiological outcome was assessed by the sponsor at 48 to 72 hours from randomization, EOT and STFU. It was based on blood and skin lesion identification results from baseline samples and skin lesion identification results from baseline samples and skin lesion identification results from follow-up samples as well as on, molecular typing results, and the IACO. Microbiological eradication rate was defined as proportion of participants with 'Documented Eradication' (absence of baseline pathogen(s) in follow-up cultures of the original site of infection.) or 'Presumed Eradication' (no material available for culture and an IACO of 'Success') in relation to the total number of participants in the respective treatment group.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population included all randomized participants who were culture positive for any staphylococcal species considered pathogenic and received at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Debio 1450 80 mg (Milligrams)/120 mg BID', 'description': 'Debio 1450 80 mg was administered intravenously twice daily (BID). After 2 doses of Debio 1450 intravenous (IV) therapy, Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.'}, {'id': 'FG001', 'title': 'Debio 1450 160 mg/240 mg BID', 'description': 'Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.'}, {'id': 'FG002', 'title': 'Vancomycin/Linezolid BID', 'description': 'Vancomycin was administered intravenously BID at doses of 1 gram (g) or 15 milligrams per kilogram (mg/kg). After 2 doses of Vancomycin IV, Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '111'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '107'}, {'groupId': 'FG002', 'numSubjects': '107'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '90'}, {'groupId': 'FG002', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'Participants took part in the study in the United States, from 14 May 2015 to 12 September 2016. Of the 505 participants screened, 175 discontinued from the study prior to randomization and 330 were randomized.', 'preAssignmentDetails': 'Participants with acute bacterial skin and skin structure infections (ABSSSI) due to Staphylococcus sensitive or resistant to Methicillin were randomized to one of the three treatment arms in a 1:1:1 ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '330', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Debio 1450 80 mg/120 mg BID', 'description': 'Debio 1450 80 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 80 mg/120 mg daily dose group received 120 mg Debio 1450 Oral + 3 dose of Debio 1450 Placebo + Linezolid matching-Placebo BID.'}, {'id': 'BG001', 'title': 'Debio 1450 160 mg/240 mg BID', 'description': 'Debio 1450 160 mg was administered intravenously BID. After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group received 240 mg Debio 1450 Oral + Linezolid matching-Placebo BID.'}, {'id': 'BG002', 'title': 'Vancomycin/Linezolid BID', 'description': 'Vancomycin was administered intravenously BID at doses of 1 g or 15 mg/kg. After 2 doses of Vancomycin IV, the Placebo comparator group received Debio 1450 matching oral placebo + Linezolid 600 mg BID.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '11.71', 'groupId': 'BG000'}, {'value': '42.8', 'spread': '11.72', 'groupId': 'BG001'}, {'value': '44.8', 'spread': '10.57', 'groupId': 'BG002'}, {'value': '43.8', 'spread': '11.34', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '227', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-Treat Population (ITT) population included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'dispFirstSubmitDate': '2017-08-21', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-24', 'studyFirstSubmitDate': '2015-04-22', 'dispFirstSubmitQcDate': '2017-08-25', 'resultsFirstSubmitDate': '2019-10-24', 'studyFirstSubmitQcDate': '2015-04-22', 'dispFirstPostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-24', 'studyFirstPostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Clinical Response Rate (ECRR): Percentage of Responders to Treatment at 48 to 72 Hours From Randomization as Assessed by the Investigator', 'timeFrame': 'At 48 to 72 hours from randomization (Day 4)', 'description': 'ECRR was defined as the percentage of responders to treatment at 48 to 72 hours from randomization. Responders were the participants who showed greater than or equal to (≥) 20% reduction in area of the primary lesion involving erythema, edema, or induration of the primary ABSSSI lesion (as assessed by the ruler method) at 48 to 72 hours compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Clinical Success Rate: Percentage of Participants Assessed by the Investigator as Responders at 48 to 72 Hours From Randomization, at End of Treatment (EOT) and Short-term Follow-up (STFU)', 'timeFrame': '48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)', 'description': 'The Investigator Assessment of Clinical Outcome (IACO) of treatment was assessed for each participant as success or failure at 48 to 72 hours after randomization at EOT and STFU visits. Clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms, or complications attributable to ABSSSI such that no further antibiotic therapy is required for treatment of original site of infection. Clinical failure was requirement for additional antibiotic therapy for treatment of the original site of infection or incision and drainage of ABSSSI site that was not both anticipated and completed within a 48- to 72-hour window following randomization, or unplanned major surgical intervention required due to failure of study medication or development of osteomyelitis after baseline. Participants who met both success criteria and none of failure criteria were considered as a clinical success for IACO.'}, {'measure': 'Clinical Success Rate: Percentage of Participants Assessed by the Sponsor as Responders After 7 to 10 Days of Treatment at EOT and STFU', 'timeFrame': 'EOT (Day 12) and STFU (Day 19)', 'description': "The Sponsor's Assessment of Clinical Outcome was obtained at EOT and STFU visits based on IACO and additional criteria. Sponsor assessed participants as clinical failure if they required non-study or rescue antibiotics due to lack of efficacy after at least 48 hours from randomization or experienced drug-related serious adverse events (SAEs) or discontinuation of study medication for drug-related AEs or required antibiotic therapy for longer than 10 days or had the need for unplanned surgical intervention \\>48 hours after randomization. As per IACO, clinical success was resolution or near resolution of most disease-specific signs and symptoms and no new signs, symptoms or complications. Clinical failure was requirement for additional antibiotic therapy or incision and drainage of ABSSSI site or unplanned major surgical intervention or development of osteomyelitis."}, {'measure': 'Percentage of Participants With a Composite Assessment of Clinical Outcome (CACO) of Success', 'timeFrame': '48 to 72 hours after randomization (Day 4) and STFU (Day 19)', 'description': 'CACO of treatment was determined as a combined outcome of early response to treatment (at 48 to 72 hours from randomization) and IACO at the STFU visit. Participants had a CACO of success if they met both of the following criteria: An early response to treatment (at 48 to 72 hours from randomization) (ECR = responder) and a clinical outcome of success at the STFU visit (7 to 14 days after EOT) based on IACO (IACO = success).'}, {'measure': 'Percentage of Participants Who Showed Microbiological Evidence of Cure 48 to 72 Hours From Randomization, EOT, and STFU', 'timeFrame': '48 to 72 hours after randomization (Day 4), EOT (Day 12) and STFU (Day 19)', 'description': "The microbiological outcome was assessed by the sponsor at 48 to 72 hours from randomization, EOT and STFU. It was based on blood and skin lesion identification results from baseline samples and skin lesion identification results from baseline samples and skin lesion identification results from follow-up samples as well as on, molecular typing results, and the IACO. Microbiological eradication rate was defined as proportion of participants with 'Documented Eradication' (absence of baseline pathogen(s) in follow-up cultures of the original site of infection.) or 'Presumed Eradication' (no material available for culture and an IACO of 'Success') in relation to the total number of participants in the respective treatment group."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bacterial Infections']}, 'referencesModule': {'references': [{'pmid': '32747361', 'type': 'DERIVED', 'citation': 'Wittke F, Vincent C, Chen J, Heller B, Kabler H, Overcash JS, Leylavergne F, Dieppois G. Afabicin, a First-in-Class Antistaphylococcal Antibiotic, in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Clinical Noninferiority to Vancomycin/Linezolid. Antimicrob Agents Chemother. 2020 Sep 21;64(10):e00250-20. doi: 10.1128/AAC.00250-20. Print 2020 Sep 21.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the efficacy of 2 different doses of intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in the treatment of patients with staphylococcal ABSSSI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has clinically documented infection of the skin or skin structure suspected or documented to be caused by a staphylococcal pathogen\n* Meets other protocol-specified criteria for qualification and contraception\n* Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications\n* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures\n\nExclusion Criteria:\n\n* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters\n* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:\n\n 1. the safety or well-being of the participant or study staff;\n 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);\n 3. the analysis of results"}, 'identificationModule': {'nctId': 'NCT02426918', 'briefTitle': 'Study of Debio 1450 for Bacterial Skin Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Debiopharm International SA'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Multicenter Study of Safety, Tolerability, and Efficacy of Debio 1450 vs Vancomycin (IV)/Linezolid (Oral) in the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Due to Staphylococcus Sensitive or Resistant to Methicillin', 'orgStudyIdInfo': {'id': 'Debio 1450-ABSSSI-201'}, 'secondaryIdInfos': [{'id': '218187', 'type': 'OTHER', 'domain': 'CRO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Debio 1450 320/480 mg', 'description': 'After 2 doses of Debio 1450 IV (intravenous) therapy, the Debio 1450 320/480 mg daily dose group receives 240 mg Debio 1450 Oral + Linezolid Placebo twice daily (BID).', 'interventionNames': ['Drug: Debio 1450 IV', 'Drug: Debio 1450 Oral', 'Drug: Linezolid Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Debio 1450 160/240 mg', 'description': 'After 2 doses of Debio 1450 IV therapy, the Debio 1450 160/240 mg daily dose group receives 120 mg Debio 1450 Oral + Debio 1450 Oral Placebo + Linezolid Placebo BID.', 'interventionNames': ['Drug: Debio 1450 IV', 'Drug: Debio 1450 Oral', 'Drug: Debio 1450 Oral Placebo', 'Drug: Linezolid Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'After 2 doses of Vancomycin IV, the Placebo comparator group receives Debio 1450 Oral Placebo + Linezolid 600 mg BID.', 'interventionNames': ['Drug: Linezolid', 'Drug: Debio 1450 Oral Placebo', 'Drug: Vancomycin IV']}], 'interventions': [{'name': 'Debio 1450 IV', 'type': 'DRUG', 'description': 'Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).', 'armGroupLabels': ['Debio 1450 160/240 mg', 'Debio 1450 320/480 mg']}, {'name': 'Debio 1450 Oral', 'type': 'DRUG', 'description': 'Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).', 'armGroupLabels': ['Debio 1450 160/240 mg', 'Debio 1450 320/480 mg']}, {'name': 'Linezolid', 'type': 'DRUG', 'description': 'Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.', 'armGroupLabels': ['Placebo']}, {'name': 'Debio 1450 Oral Placebo', 'type': 'DRUG', 'description': 'Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.', 'armGroupLabels': ['Debio 1450 160/240 mg', 'Placebo']}, {'name': 'Linezolid Placebo', 'type': 'DRUG', 'description': 'Linezolid placebo will be supplied as film-coated compressed tablets.', 'armGroupLabels': ['Debio 1450 160/240 mg', 'Debio 1450 320/480 mg']}, {'name': 'Vancomycin IV', 'type': 'DRUG', 'description': 'Vancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91776', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Dream Team Clinical Research, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Physician Alliance Research Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90620', 'city': 'Buena Park', 'state': 'California', 'country': 'United States', 'facility': 'Southbay Pharma Research', 'geoPoint': {'lat': 33.86751, 'lon': -117.99812}}, {'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'eStudySite - Chula Vista', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'eStudySite - La Mesa', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Clinical Trials LLC', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Alliance Research', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '95350', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Central Valley Research, LLC', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'facility': 'eStudySite - Oceanside', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '91342', 'city': 'Sylmar', 'state': 'California', 'country': 'United States', 'facility': 'Olive View - UCLA Medical Center', 'geoPoint': {'lat': 34.30778, 'lon': -118.44925}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands Burn Center at the University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32811', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Central Florida Internists', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33401', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Triple O Research Institute', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Columbus Regional Research', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Beaumont Infectious Disease Services', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Mercury Street Medical Group PLLC', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'eStudySite - Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08244', 'city': 'Somers Point', 'state': 'New Jersey', 'country': 'United States', 'facility': 'South Jersey Infectious Disease', 'geoPoint': {'lat': 39.31762, 'lon': -74.5946}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Holy Name Medical Center', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '43608', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'ID Clinical Research, Ltd.', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '77070', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'East Montgomery County Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77372', 'city': 'Splendora', 'state': 'Texas', 'country': 'United States', 'facility': 'Tidwell Medical Center', 'geoPoint': {'lat': 30.23299, 'lon': -95.16104}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Debiopharm International SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}