Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2025-12-27 @ 9:12 PM
Study NCT ID:
NCT01593761
Status:
COMPLETED
Last Update Posted:
2022-09-10
First Post:
2012-05-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002481', 'term': 'Cellulitis'}], 'ancestors': [{'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523750', 'term': 'CG 400549'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sgro@cgxinc.com', 'phone': '82 31 628 2783', 'title': 'Seonggu Ro, Ph.D, Chief Technology Officer', 'organization': 'CrystalGenomics, Inc.'}, 'certainAgreement': {'otherDetails': 'the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than or equal to 60 days but less than or equal to 120 days from the time submitted to the sponsor for review.\n\nThe sponsor can request to remove any confidential information (other than study results).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).", 'eventGroups': [{'id': 'EG000', 'title': 'Subjects Proven MRSA, mMITT', 'description': 'The primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA', 'otherNumAtRisk': 11, 'otherNumAffected': 10, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Subjects Received CG400549, MITT', 'description': 'All enrolled subjects who received any amount of study drug and was equivalent to the safety population.', 'otherNumAtRisk': 20, 'otherNumAffected': 13, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'injection site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'pharyngitis streptococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'urinary track infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'Road Traffic Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 15.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Status of Subject's Clinical Responses", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Proven MRSA, mMITT', 'description': 'The primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA'}], 'classes': [{'title': 'Stable/ Improving Infection', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'No Stable/ Improving Infection', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)', 'description': 'Stable/improving infection, as defined by the Investigator assessment, was defined as cessation of the spread of the redness, edema, and/or induration of the lesion or reduction in the size (length, width, and shortest distance from the peripheral margin of the abscess) of redness, edema, and/or induration and absence of fever (\\< 37.7 °C)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among 20 participated subjects, 11 subjects had confirmed MRSA and qualified for the mMITT population'}, {'type': 'SECONDARY', 'title': "Status of Subject's Clinical Response", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Proven MRSA, CE', 'description': 'Primary population for assessment of clinical cure and was defined separately for the EOT and TOC visits.\n\nThe mMITT subjects who did not have major protocol violations and received at least 80% of the planned dose of CG400549 were candidates for the CE population.\n\n1. CE subjects at EOT who met the above criteria and had a clinical lesion assessment at the EOT visit.\n2. CE subjects at TOC who met the above criteria and had a clinical lesion assessment at the TOC visit.'}], 'classes': [{'title': 'Clinical Cure at EOT', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}]}]}, {'title': 'Clinical Improvement at EOT', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '100'}]}]}, {'title': 'Clinical Failure at EOT', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Clinical Cure at TOC', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Clinical Improvement at TOC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Clinical Failure at TOC', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)', 'description': '1. Clinical cure was defined as absence of fever (\\< 37.7°C); presence of granulation or wound healing; resolution of pain; and decreased or resolved erythema, edema,induration, and color. Ulceration could persist, but lesions had to appear non-infected to be defined as clinical cure.\n2. Clinical improvement was defined as moderate resolution of 2 or more clinical symptoms.\n3. clinical failure was defined as persistence or progression of baseline signs and symptoms of cABSSSI, development of new signs and symptoms consistent with Gram-positive infection, or inability to complete the study because of AEs', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Among 11 mMITT population who had proven MRSA , 2 subjects had major protocol violations, yielding 9 subjects for CE population'}, {'type': 'SECONDARY', 'title': "Status of Subject's Microbial Eradication Response", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Proven MRSA, ME', 'description': 'The primary population for assessment of microbial eradiation and was defined separately for the EOT and TOC visits.\n\nThe mMITT subjects who did not have major protocol violations and received at least 80% of the planned dose of CG400549 were candidates for the ME population.\n\n1. ME subjects at EOT who met the above criteria and had an interpretable culture for microbial response at EOT.\n2. ME subjects at TOC who met the above criteria and had an interpretable culture for microbial response at TOC.'}], 'timeFrame': 'End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)', 'description': '1. Microbial eradication was defined by culture (complete absence of all infecting organisms identified at baseline) or presumed because of an absence of clinical symptoms.\n2. Microbiological Persistence was defined as the presence of one or more of the original infecting organisms on the TOC culture or as the absence of cultures in case of clinical failure.\n3. Microbiological Recurrence was defined as the presence on the final culture of an original infecting organism whose eradication had been either documented or presumed a the end of therapy.', 'reportingStatus': 'POSTED', 'populationDescription': 'The ME group was not analyzed because the appropriate post-treatment skin culture data were not accessible due to the improvement of infected lesion.'}, {'type': 'SECONDARY', 'title': 'Overall Summary of Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Received CG400549, MITT', 'description': 'All enrolled subjects who receive any amount of study drug and was equivalent to the safety population.'}, {'id': 'OG001', 'title': 'Subjects Proven MRSA, mMITT', 'description': 'The mMITT population was the primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA'}], 'classes': [{'title': 'Treatment-Emergent Adverse Event (TEAE)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Severe TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-Related TEAE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Severe Treatment-Related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAE with outcome of death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'TEAE leading to withdrawal of study medic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Serious Adverse Event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From time of signing the informed consent to Test of Cure (TOC, 21-28 days after after beginning treatment)', 'description': 'Treatment-Emergent Adverse Event (TEAE) are those that\n\n1. Emerging during treatment, having been absent pre-treatment or\n2. Reemerge during treatment, having been present at baseline but stopped prior to treatment or\n3. Worsen in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Plasma Concentration-time Profile of CG400549', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Proven MRSA, mMITT', 'description': 'MITT subjects who had confirmed MRSA'}], 'classes': [{'title': 'Day 1 predose', 'categories': [{'measurements': [{'value': '32.921', 'spread': '101.5', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 1hour', 'categories': [{'measurements': [{'value': '426.921', 'spread': '488.5', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 2hour', 'categories': [{'measurements': [{'value': '1,366.159', 'spread': '1028.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 1 4hour', 'categories': [{'measurements': [{'value': '1,618.997', 'spread': '782.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 predose, Day 1 1hour, Day 1 2hour, Day 1 4hour', 'description': 'The concentrations of CG400549 in plasma collected at each point were analyzed and calculated for its mean plasma concentration.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subjects Received CG400549, MITT', 'description': 'All enrolled subjects who received any amount of study drug and was equivalent to the safety population.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'culture negative for MRSA at baseline', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'positive for hepatitis C virus', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'secondary cellulitis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects with complicated acute bacterial skin and skin structure infection were recruited. Study was conducted from June 2012 to October 2012 at 1 site in the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects Received CG400549, MITT', 'description': 'All enrolled subjects who received any amount of study drug and was equivalent to the safety population.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35.2', 'spread': '13.27', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2012-05-06', 'resultsFirstSubmitDate': '2013-04-11', 'studyFirstSubmitQcDate': '2012-05-06', 'lastUpdatePostDateStruct': {'date': '2022-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-12', 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Status of Subject's Clinical Responses", 'timeFrame': 'Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)', 'description': 'Stable/improving infection, as defined by the Investigator assessment, was defined as cessation of the spread of the redness, edema, and/or induration of the lesion or reduction in the size (length, width, and shortest distance from the peripheral margin of the abscess) of redness, edema, and/or induration and absence of fever (\\< 37.7 °C)'}], 'secondaryOutcomes': [{'measure': "Status of Subject's Clinical Response", 'timeFrame': 'End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)', 'description': '1. Clinical cure was defined as absence of fever (\\< 37.7°C); presence of granulation or wound healing; resolution of pain; and decreased or resolved erythema, edema,induration, and color. Ulceration could persist, but lesions had to appear non-infected to be defined as clinical cure.\n2. Clinical improvement was defined as moderate resolution of 2 or more clinical symptoms.\n3. clinical failure was defined as persistence or progression of baseline signs and symptoms of cABSSSI, development of new signs and symptoms consistent with Gram-positive infection, or inability to complete the study because of AEs'}, {'measure': "Status of Subject's Microbial Eradication Response", 'timeFrame': 'End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)', 'description': '1. Microbial eradication was defined by culture (complete absence of all infecting organisms identified at baseline) or presumed because of an absence of clinical symptoms.\n2. Microbiological Persistence was defined as the presence of one or more of the original infecting organisms on the TOC culture or as the absence of cultures in case of clinical failure.\n3. Microbiological Recurrence was defined as the presence on the final culture of an original infecting organism whose eradication had been either documented or presumed a the end of therapy.'}, {'measure': 'Overall Summary of Adverse Events', 'timeFrame': 'From time of signing the informed consent to Test of Cure (TOC, 21-28 days after after beginning treatment)', 'description': 'Treatment-Emergent Adverse Event (TEAE) are those that\n\n1. Emerging during treatment, having been absent pre-treatment or\n2. Reemerge during treatment, having been present at baseline but stopped prior to treatment or\n3. Worsen in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.'}, {'measure': 'Mean Plasma Concentration-time Profile of CG400549', 'timeFrame': 'Day 1 predose, Day 1 1hour, Day 1 2hour, Day 1 4hour', 'description': 'The concentrations of CG400549 in plasma collected at each point were analyzed and calculated for its mean plasma concentration.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cABSSSI', 'MRSA'], 'conditions': ['Skin Infection']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nTo make a preliminary assessment of the efficacy of CG400549 (960 mg daily) in subjects with cABSSSI (major cutaneous abscesses) due to MRSA.\n\nSecondary Objective(s):\n\n* To assess the pharmacokinetics of CG400549 (960 mg daily) in subjects with cABSSSI due to MRSA\n* To explore the in vitro susceptibility of cABSSSI-related bacteria to CG400549.\n* To assess the safety of multiple doses of CG400459', 'detailedDescription': 'This will be an open-label, exploratory study to evaluate the safety, pharmacokinetics, and efficacy of CG400549, daily for 10 to 14 days, in subjects with cABSSSI (major cutaneous abscesses) due to MRSA. All subjects will receive active treatment.\n\nSubjects will begin study treatment upon confirmation of clinical eligibility (ie, confirmation of MRSA infection is not required pretreatment). Subjects who begin treatment with CG400549 and are subsequently not found to have S. aureus infection will be discontinued from study treatment, treated as appropriate for the identified pathogen(s), and followed for safety. These subjects will be included in the safety analyses but not in the primary efficacy analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of major cutaneous abscess suspected or confirmed to be caused by a MRSA.\n2. Signs and symptoms should include at least 2 of the following: purulent drainage or discharge, erythema, fluctuance, heat or localized warmth, edema/induration, pain or tenderness to palpation\n\nExclusion Criteria:\n\n1. Prior systemic or topical antibacterial therapy\n2. Severe sepsis or refractory shock'}, 'identificationModule': {'nctId': 'NCT01593761', 'acronym': 'CG400549', 'briefTitle': 'Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus', 'organization': {'class': 'INDUSTRY', 'fullName': 'CrystalGenomics, Inc.'}, 'officialTitle': 'Phase 2a, Repeated-dose, Open-label, Single-arm Study of CG400549 for the Treatment of Complicated Acute Bacterial Skin and Skin Structure Infection (cABSSSI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)', 'orgStudyIdInfo': {'id': 'CG400549-2-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm for CG400549', 'description': 'All the patients will be administered with CG400549.', 'interventionNames': ['Drug: CG400549']}], 'interventions': [{'name': 'CG400549', 'type': 'DRUG', 'description': '960mg QD at fed state approx 1 hour after meal', 'armGroupLabels': ['Single Arm for CG400549']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'eStudysite', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}], 'overallOfficials': [{'name': 'Jeffrey S. Overcash, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'eStudysite'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CrystalGenomics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}