Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2026-02-24 @ 4:26 PM
Study NCT ID:
NCT03782103
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2018-12-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-06-23', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D002864', 'term': 'Chromogranins'}, {'id': 'C010882', 'term': 'chlorhexidine gluconate'}, {'id': 'C547847', 'term': 'citrate, isopropyl alcohol, methylene blue, parabens drug combination'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amorgan1@charter.net', 'phone': '16082175239', 'title': 'Andrew Morgan Exec. VP RA/QA Clinical', 'organization': 'Zurex Pharma'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 hours post product application', 'eventGroups': [{'id': 'EG000', 'title': 'Zurex Prep (70% IPA)', 'description': 'Isopropyl alcohol (IPA) 70%\n\nZuraGard Clear Solution: Apply topically.', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 0, 'seriousNumAtRisk': 156, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ChloraPrep', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%\n\nChloraPrep: Apply topically.', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 0, 'seriousNumAtRisk': 156, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Zurex Prep Vehicle', 'description': 'Zurex Prep without IPA\n\nZurex Prep Vehicle: Apply topically.', 'otherNumAtRisk': 156, 'deathsNumAtRisk': 156, 'otherNumAffected': 0, 'seriousNumAtRisk': 156, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bacterial Reduction - Groin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}, {'units': 'Abdomen or groin', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mean Log Reduction - ZP (70% IPA) - Groin', 'description': 'Isopropyl alcohol (IPA) 70%\n\nZP: Apply topically.'}, {'id': 'OG001', 'title': 'Mean Log Reduction - ChloraPrep - Groin', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%\n\nChloraPrep: Apply topically.'}, {'id': 'OG002', 'title': 'Mean Log Reduction - ZP Vehicle - Groin', 'description': 'ZP without IPA\n\nZP Vehicle: Apply topically.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.133', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.642', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.277', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2845', 'ciLowerLimit': '-0.6033', 'ciUpperLimit': '0.0334', 'groupDescription': 'Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\\^2 bacterial counts and the predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\\^2 bacterial counts as a covariate.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Investigational product upper bounds must be less than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.8535', 'ciLowerLimit': '2.5415', 'ciUpperLimit': '3.1655', 'groupDescription': 'Groin 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\\^2 bacterial counts as a covariate.', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Investigational product lower bounds must be greater than 1.2.'}], 'paramType': 'MEAN', 'timeFrame': '30 seconds post product application', 'description': 'A 3-log10 CFU/cm\\^2 bacterial reduction on the inguinal region is considered a success.', 'unitOfMeasure': 'log 10 CFU/cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Abdomen or groin', 'denomUnitsSelected': 'Abdomen or groin', 'populationDescription': 'Treated subjects with a treatment day baseline criteria of 5.0-7.5 log10 CFU/cm\\^2 recoveries for each sampling site (2 groin sampling sites per subject).'}, {'type': 'PRIMARY', 'title': 'Bacterial Reduction - Abdomen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}, {'value': '156', 'groupId': 'OG002'}]}, {'units': 'Abdomen or groin', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Mean Log Reduction - ZP (70% IPA) - Abdomen', 'description': 'Isopropyl alcohol (IPA) 70%\n\nZP: Apply topically.'}, {'id': 'OG001', 'title': 'Mean Log Reduction - ChloraPrep - Abdomen', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%\n\nChloraPrep: Apply topically.'}, {'id': 'OG002', 'title': 'Mean Log Reduction - ZP Vehicle - Abdomen', 'description': 'ZP without IPA\n\nZP Vehicle: Apply topically.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.036', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '3.087', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '1.234', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0577', 'ciLowerLimit': '-0.1457', 'ciUpperLimit': '0.2611', 'groupDescription': 'Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\\^2 bacterial counts as a covariate.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Investigational product average treatment effect upper bounds cannot be more than 0.5.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8208', 'ciLowerLimit': '1.6153', 'ciUpperLimit': '2.0264', 'groupDescription': 'Abdomen 30 seconds post product application, Average Treatment Effect, calculated using a linear regression model for each body site, was used for primary analysis. In the model, the response was the post-treatment log10 CFU/cm\\^2 bacterial counts and predictors were the treatment effect as a fixed effect and the pre-treatment log10 CFU/cm\\^2 bacterial counts as a covariate.', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Investigational product lower bounds must be greater than 1.2.'}], 'paramType': 'MEAN', 'timeFrame': '30 seconds post product application', 'description': 'A 2-log10 CFU/cm\\^2 bacterial reduction on the abdomen region is considered a success.', 'unitOfMeasure': 'Log10 CFU/cm^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Abdomen or groin', 'denomUnitsSelected': 'Abdomen or groin', 'populationDescription': 'Treated subjects with a treatment day baseline criteria of 3.0 - 5.5 Log10 CFU/cm\\^2 recoveries.'}, {'type': 'SECONDARY', 'title': 'Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}]}, {'units': 'Abdomen or groin', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ZP (70% IPA)', 'description': 'Isopropyl alcohol (IPA) 70% - 6 hr post product application\n\nZP: Apply topically.'}], 'classes': [{'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 hours post product applcation', 'description': 'Bacterial counts should not exceed baseline on the abdomen or groin region', 'unitOfMeasure': 'Abd or groin with persistent effect', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Abdomen or groin', 'denomUnitsSelected': 'Abdomen or groin', 'populationDescription': 'Subjects were treated and post treatment the 6 hour log10 CFU/cm2 values were evaluated for persistence. If the 6 hour value was below the baseline log10CFU/cm2 value, then the site had a persistent effect. This was calculated as a binary variable: 1 if the site had a persistent effect; 0 if not.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Study Participants', 'description': 'ZP (Isopropyl alcohol (IPA) 70%) or CP or ZP Vehicle, applied topically to abdominal (for 30 seconds) or groin (for 2 minutes).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '72', 'numSubjects': '156'}]}, {'type': 'ZP', 'achievements': [{'groupId': 'FG000', 'numUnits': '72', 'numSubjects': '156'}]}, {'type': 'CP', 'achievements': [{'groupId': 'FG000', 'numUnits': '72', 'numSubjects': '156'}]}, {'type': 'Vehicle', 'achievements': [{'groupId': 'FG000', 'numUnits': '72', 'numSubjects': '156'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '72', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Ab or groin', 'preAssignmentDetails': 'Enrollment consists of subjects that advanced from screening to randomization and treatment. Each subject had 2 test products applied bilaterally; therefore, the numbers will not add up uniformly across arms due to the pre-determined cohort/block design. Result totals will be less than than the treated number as the per subject/area/intervention anatomical site must have an acceptable baseline count/flora.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'BG000'}]}, {'units': 'Abdomen or groin', 'counts': [{'value': '72', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Population', 'description': 'Each subject could have received 2 out of 3 test products randomly assigned. Demographics were not stratified by test product due to study design. While 156 was the treated population, to be evaluable for efficacy, each subject anatomical sample site (4/per subject) would need to pass the minimum log10 CFU/cm2 baseline requirements.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '156', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.90', 'spread': '14.93', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '150', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '59', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '156', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'Abdomen or groin', 'populationDescription': 'Subjects must have the following bacteria counts to entry study, for the abdomen, the allowable baseline log10 CFU/cm2 value \\> 3.0; for the groin, the allowable baseline log10 CFU/cm2 value \\> 5.0.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-04', 'size': 1078277, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-05-23T13:34', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'dispFirstSubmitDate': '2020-06-29', 'completionDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2018-12-18', 'dispFirstSubmitQcDate': '2022-06-24', 'resultsFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2018-12-18', 'dispFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-24', 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial Reduction - Groin', 'timeFrame': '30 seconds post product application', 'description': 'A 3-log10 CFU/cm\\^2 bacterial reduction on the inguinal region is considered a success.'}, {'measure': 'Bacterial Reduction - Abdomen', 'timeFrame': '30 seconds post product application', 'description': 'A 2-log10 CFU/cm\\^2 bacterial reduction on the abdomen region is considered a success.'}], 'secondaryOutcomes': [{'measure': 'Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region', 'timeFrame': '6 hours post product applcation', 'description': 'Bacterial counts should not exceed baseline on the abdomen or groin region'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Skin Preparation']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.', 'detailedDescription': 'The primary objective of this study is to measure the antimicrobial effectiveness of a single investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™ as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle as a negative control. For efficacy at 30 seconds post-prep, the test article should be superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non-inferior to the active control using a margin of 0.5 log10 CFU/cm2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects of any race\n* Subjects in good general health\n* Minimum bacterial baseline requirements on abdomen and groin\n* Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.\n\nExclusion Criteria:\n\n* Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.\n* Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to screening and treatment days, excluding contraception or post-menopausal treatment.\n* Subjects with allergies to study materials including isopropyl alcohol or chlorhexidine gluconate.\n* Subjects with a history of skin sensitivity, skin allergies, or skin cancer.\n* Subjects who are pregnant, attempting pregnancy or nursing.'}, 'identificationModule': {'nctId': 'NCT03782103', 'acronym': 'ZP', 'briefTitle': 'In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zurex Pharma, Inc.'}, 'officialTitle': 'Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep', 'orgStudyIdInfo': {'id': 'ZX-ZP-0092 / 865-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ZuraPrep (70% IPA)', 'description': 'Isopropyl alcohol (IPA) 70%', 'interventionNames': ['Drug: ZuraPrep Clear Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ChloraPrep', 'description': 'Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%', 'interventionNames': ['Drug: ChloraPrep']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'ZuraPrep Vehicle', 'description': 'Zurex Prep without IPA', 'interventionNames': ['Drug: ZuraPrep Vehicle']}], 'interventions': [{'name': 'ZuraPrep Clear Solution', 'type': 'DRUG', 'otherNames': ['Isopropyl alcohol 70%', 'ZP'], 'description': 'Apply topically.', 'armGroupLabels': ['ZuraPrep (70% IPA)']}, {'name': 'ChloraPrep', 'type': 'DRUG', 'otherNames': ['CHG 2%/IPA 70%', 'Chlorhexidine gluconate 2% / Isopropyl alcohol 70%'], 'description': 'Apply topically.', 'armGroupLabels': ['ChloraPrep']}, {'name': 'ZuraPrep Vehicle', 'type': 'DRUG', 'otherNames': ['Vehicle'], 'description': 'Apply topically.', 'armGroupLabels': ['ZuraPrep Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20164', 'city': 'Sterling', 'state': 'Virginia', 'country': 'United States', 'facility': 'Microbac Laboratories, Inc.', 'geoPoint': {'lat': 39.00622, 'lon': -77.4286}}], 'overallOfficials': [{'name': 'M H Bashir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Microbac Laboratories, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zurex Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}