Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 4:10 PM
Study NCT ID:
NCT01209234
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2010-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sshuang@uci.edu', 'phone': '949-824-5073', 'title': 'Susan Huang, Principal Investigator & Medical Director of Epidemiology and Infection Prevention', 'organization': 'University of California, Irvine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were actively assessed from January 2011-January 2015. Participants were recruited from January 2011-January 2014 and were followed for 1 year. Evaluation of the full text medical record reviews for adverse events occurred for several years after recruitment ended in 2014.', 'eventGroups': [{'id': 'EG000', 'title': 'MRSA Decolonization', 'description': 'Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.\n\nMRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.', 'otherNumAtRisk': 1058, 'deathsNumAtRisk': 1058, 'otherNumAffected': 48, 'seriousNumAtRisk': 1058, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Education Arm', 'description': 'Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.\n\nStandard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.', 'otherNumAtRisk': 1063, 'deathsNumAtRisk': 1063, 'otherNumAffected': 0, 'seriousNumAtRisk': 1063, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasal Mupirocin (2%)', 'notes': 'Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Mupirocin (2%)', 'notes': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Mupirocin (2%)', 'notes': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Mupirocin (2%)', 'notes': 'Numb throat, tast change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Mupirocin (2%)', 'notes': 'Runny, itchy nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Mupirocin (2%)', 'notes': 'Runny nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Mupirocin (2%)', 'notes': 'Loss of smell and taste', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Mouthwash (0.12%)', 'notes': 'Tongue discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Mouthwash (0.12%)', 'notes': 'Tingling tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Mouthwash (0.12%)', 'notes': 'Tingling of mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Mouthwash (0.12%)', 'notes': 'Teeth staining', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Mouthwash (0.12%)', 'notes': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Mouthwash (0.12%)', 'notes': 'Oral irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Itchy, dry hands', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Itchy body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Itchy face and neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Itchy, dry scalp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Dry, flaky hands and feet', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Burning sensation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Rash: trunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Rash: body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Rash: face and neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Rash: chest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Rash: legs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Rash: scrotal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Rash: neck, limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Rash and dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chlorhexidine Bodywash (4%)', 'notes': 'Rash: leg', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1058, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1063, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to MRSA Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1058', 'groupId': 'OG000'}, {'value': '1063', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MRSA Decolonization', 'description': 'Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.\n\nMRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.'}, {'id': 'OG001', 'title': 'Education Arm', 'description': 'Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.\n\nStandard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.'}], 'classes': [{'title': 'MRSA Infection defined by CDC Criteria', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'MRSA Infection defined by Clinical Criteria', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.96', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.024', 'estimateComment': 'This is the estimated standard error of the log hazard ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Time in days to MRSA inpatient or outpatient infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year post discharge)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcomes were analyzed according to the as-treated adherence strata (fully adherent, partially adherent, and nonadherent participant-time)'}, {'type': 'SECONDARY', 'title': 'Time to All-cause Infection (Steering Committee Modified Oct 2011)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1058', 'groupId': 'OG000'}, {'value': '1063', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MRSA Decolonization', 'description': 'Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.\n\nMRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.'}, {'id': 'OG001', 'title': 'Education Arm', 'description': 'Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.\n\nStandard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.'}], 'classes': [{'title': 'All-Cause Infection defined by CDC Criteria', 'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}]}, {'title': 'All-Cause Infection defined by Clinical Criteria', 'categories': [{'measurements': [{'value': '246', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.061', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.01', 'pValueComment': 'Not adjusted for multiple comparisons', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.009', 'estimateComment': 'CDC-defined all-cause infection secondary outcome This is the estimated standard error of the log hazard ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.70', 'ciUpperLimit': '0.99', 'pValueComment': 'Not adjusted for multiple comparisons', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.008', 'estimateComment': 'Clinical criteria for all-cause infection This is the estimated standard error of the log hazard ratio', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Time in days to all-cause infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of MRSA Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1058', 'groupId': 'OG000'}, {'value': '1063', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MRSA Decolonization', 'description': 'Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.\n\nMRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.'}, {'id': 'OG001', 'title': 'Education Arm', 'description': 'Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.\n\nStandard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Event count of outpatient and inpatient MRSA infections occurring after enrollment', 'calculatePct': False, 'unitOfMeasure': 'MRSA Infection Events', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2025-04'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rehospitalization Due to MRSA Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1058', 'groupId': 'OG000'}, {'value': '1063', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MRSA Decolonization', 'description': 'Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.\n\nMRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.'}, {'id': 'OG001', 'title': 'Education Arm', 'description': 'Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.\n\nStandard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 year', 'description': 'Number of participants experiencing rehospitalization due to MRSA infection (first only)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2025-04'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cost and Cost Savings Associated With Post-discharge MRSA Decolonization', 'timeFrame': '1 year', 'description': 'Medical and non-medical costs of MRSA infection within the 1 year follow up period', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2027-04'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of All-cause Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1058', 'groupId': 'OG000'}, {'value': '1063', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MRSA Decolonization', 'description': 'Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.\n\nMRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.'}, {'id': 'OG001', 'title': 'Education Arm', 'description': 'Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.\n\nStandard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.'}], 'classes': [{'categories': [{'measurements': [{'value': '207', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'Event count of all-cause infections occurring after enrollment', 'unitOfMeasure': 'All-cause infection events', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2025-04'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MRSA Decolonization', 'description': 'Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.\n\nMRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.'}, {'id': 'FG001', 'title': 'Education Arm', 'description': 'Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.\n\nStandard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1070'}, {'groupId': 'FG001', 'numSubjects': '1070'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1058'}, {'groupId': 'FG001', 'numSubjects': '1063'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Recruitment occurred between January 10, 2011 and January 2, 2014, during inpatient admissions in 17 hospitals and 7 nursing homes in Southern California.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1058', 'groupId': 'BG000'}, {'value': '1063', 'groupId': 'BG001'}, {'value': '2121', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'MRSA Decolonization', 'description': 'Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.\n\nMRSA Decolonization: Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.'}, {'id': 'BG001', 'title': 'Education Arm', 'description': 'Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.\n\nStandard-of-Care Education: Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '17', 'groupId': 'BG000'}, {'value': '56', 'spread': '17', 'groupId': 'BG001'}, {'value': '56', 'spread': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '493', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '973', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '565', 'groupId': 'BG000'}, {'value': '583', 'groupId': 'BG001'}, {'value': '1148', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '840', 'groupId': 'BG000'}, {'value': '844', 'groupId': 'BG001'}, {'value': '1684', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '256', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'American Indian', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Unknown/Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1058', 'groupId': 'BG000'}, {'value': '1063', 'groupId': 'BG001'}, {'value': '2121', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-04-07', 'size': 1143531, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-08-12T17:21', 'hasProtocol': True}, {'date': '2012-09-18', 'size': 120935, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-08-12T17:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2010-09-23', 'resultsFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2010-09-23', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2020-08-28', 'studyFirstPostDateStruct': {'date': '2010-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of MRSA Infections', 'timeFrame': '1 year', 'description': 'Event count of outpatient and inpatient MRSA infections occurring after enrollment'}, {'measure': 'Rehospitalization Due to MRSA Infection', 'timeFrame': '1 year', 'description': 'Number of participants experiencing rehospitalization due to MRSA infection (first only)'}, {'measure': 'Cost and Cost Savings Associated With Post-discharge MRSA Decolonization', 'timeFrame': '1 year', 'description': 'Medical and non-medical costs of MRSA infection within the 1 year follow up period'}, {'measure': 'Number of All-cause Infections', 'timeFrame': '1 year', 'description': 'Event count of all-cause infections occurring after enrollment'}], 'primaryOutcomes': [{'measure': 'Time to MRSA Infection', 'timeFrame': '1 year', 'description': 'Time in days to MRSA inpatient or outpatient infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year post discharge)'}], 'secondaryOutcomes': [{'measure': 'Time to All-cause Infection (Steering Committee Modified Oct 2011)', 'timeFrame': '1 year', 'description': 'Time in days to all-cause infection (analyzed with the use of unadjusted Cox proportional-hazard models to identify time to infection; the results we are reporting are number of participants who had an infection event at one year)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Methicillin-resistant Staphylococcus aureus', 'MRSA'], 'conditions': ['Methicillin-resistant Staphylococcus Aureus']}, 'referencesModule': {'references': [{'pmid': '18258033', 'type': 'BACKGROUND', 'citation': 'Klein E, Smith DL, Laxminarayan R. Hospitalizations and deaths caused by methicillin-resistant Staphylococcus aureus, United States, 1999-2005. Emerg Infect Dis. 2007 Dec;13(12):1840-6. doi: 10.3201/eid1312.070629.'}, {'pmid': '12539068', 'type': 'BACKGROUND', 'citation': 'Huang SS, Platt R. Risk of methicillin-resistant Staphylococcus aureus infection after previous infection or colonization. Clin Infect Dis. 2003 Feb 1;36(3):281-5. doi: 10.1086/345955. Epub 2003 Jan 17.'}, {'type': 'BACKGROUND', 'citation': 'Huang SS, Hinrichsen VH, Stulgis L, Miroshnik I, Datta R, Watson K, Platt R. Methicillin-resistant Staphylococcus aureus Infection in the Year Following Detection of Carriage (oral presentation). Society of Healthcare Epidemiology of America Annual Meeting (Chicago, IL), March 18-21, 2006.'}, {'pmid': '17940231', 'type': 'BACKGROUND', 'citation': 'Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, Harrison LH, Lynfield R, Dumyati G, Townes JM, Craig AS, Zell ER, Fosheim GE, McDougal LK, Carey RB, Fridkin SK; Active Bacterial Core surveillance (ABCs) MRSA Investigators. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA. 2007 Oct 17;298(15):1763-71. doi: 10.1001/jama.298.15.1763.'}, {'pmid': '30763195', 'type': 'DERIVED', 'citation': 'Huang SS, Singh R, McKinnell JA, Park S, Gombosev A, Eells SJ, Gillen DL, Kim D, Rashid S, Macias-Gil R, Bolaris MA, Tjoa T, Cao C, Hong SS, Lequieu J, Cui E, Chang J, He J, Evans K, Peterson E, Simpson G, Robinson P, Choi C, Bailey CC Jr, Leo JD, Amin A, Goldmann D, Jernigan JA, Platt R, Septimus E, Weinstein RA, Hayden MK, Miller LG; Project CLEAR Trial. Decolonization to Reduce Postdischarge Infection Risk among MRSA Carriers. N Engl J Med. 2019 Feb 14;380(7):638-650. doi: 10.1056/NEJMoa1716771.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial will compare strategies to reduce the risk of methicillin-resistant Staphylococcus aureus (MRSA) infection and re-hospitalization in MRSA carriers. This trial will provide critical answers about the role of decolonization versus standard-of-care education in preventing MRSA infections in the large group of high risk MRSA-positive patients being discharged from hospitals. Findings could potentially impact best practice for the 1.8 million MRSA carriers who are discharged from US hospitals each year.', 'detailedDescription': 'This randomized controlled trial will compare strategies to reduce the risk of methicillin-resistant Staphylococcus aureus (MRSA) infection and re-hospitalization in MRSA carriers. This trial will provide critical answers about the role of decolonization versus standard-of-care education in preventing MRSA infections in the large group of high risk MRSA+ patients being discharged from hospitals. Findings could potentially impact best practice for the 1.8 million MRSA carriers who are discharged from US hospitals each year.\n\nSpecific Aims:\n\nMethicillin-resistant Staphylococcus aureus (MRSA) is arguably the most important single pathogen in healthcare-associated infection when accounting for virulence, prevalence, diversity of disease spectrum, and propensity for widespread transmission. MRSA infection causes or complicates 300,000 hospitalizations each year \\[Klein, Smith, Laxminarayan\\], a number which has doubled in the past five years. An additional 1.5 million hospitalized patients either acquire or already harbor the pathogen without current infection. Altogether, these 1.8 million MRSA inpatient carriers experience a high amount of MRSA invasive disease in the year following discharge. Due to increased delivery of complex medical care at home or other post-hospital settings, more and more patients experience serious healthcare-associated morbidity after hospital discharge.\\[Huang, Platt; Huang, Hinrichsen, Stulgis et al.\\] In fact, over 80% of patients admitted for MRSA infection have had prior healthcare exposures and are at high risk for repeated MRSA infection.\\[Huang, Platt; Huang, Hinrichsen, Stulgis et al.; Klevens, Morrison, Nadle, et al.\\]\n\nProject CLEAR compares two strategies to reduce infection and re-hospitalization due to MRSA among patients being discharged from hospitals. Our trial will compare a long-term regimen aimed at eradicating MRSA body reservoirs with patient education on general hygiene and self care, which is the current standard of care. Our specific aims are:\n\n* To conduct a randomized controlled trial of serial decolonization versus standard-of-care patient education among MRSA carriers upon hospital discharge to reduce post-discharge MRSA infection and re-hospitalization for one year\n* To identify predictors of a) infection or re-hospitalization due to MRSA, and b) successful MRSA decolonization, including patient demographics, comorbidities, medical devices, risk behaviors, socioeconomic status, and colonizing MRSA genotype\n* To estimate medical and non-medical costs of MRSA infection among MRSA carriers and evaluate the potential for cost savings associated with decolonization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) At least 18 years old\n* 2\\) Have had a positive culture (a type of test) for MRSA during recent hospital admission or within the 30 days prior to admission or following discharge\n* 3\\) Able to give consent or have a primary caregiver provide consent\n* 4\\) Able to bathe or shower or have this consistently performed by a willing caregiver\n\nExclusion Criteria:\n\n* 1\\) Known allergies to chlorhexidine or mupirocin'}, 'identificationModule': {'nctId': 'NCT01209234', 'acronym': 'CLEAR', 'briefTitle': 'Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Project CLEAR - Changing Lives by Eradicating Antibiotic Resistance', 'orgStudyIdInfo': {'id': '2010-7710'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MRSA Decolonization', 'description': 'Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.', 'interventionNames': ['Drug: MRSA Decolonization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Education Arm', 'description': 'Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home. In addition, educational material on hygiene practices to prevent MRSA infection will be provided.', 'interventionNames': ['Behavioral: Standard-of-Care Education']}], 'interventions': [{'name': 'Standard-of-Care Education', 'type': 'BEHAVIORAL', 'description': 'Patients randomized to standard education will receive a binder with MRSA educational materials which will include or be based upon CDC guidance for MRSA patients at home.', 'armGroupLabels': ['Education Arm']}, {'name': 'MRSA Decolonization', 'type': 'DRUG', 'description': 'Participants in this arm will be instructed to complete a decolonization regimen that will involve a 5-day application of nasal mupirocin, oral CHG rinse, and CHG body wash twice a month.', 'armGroupLabels': ['MRSA Decolonization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92656', 'city': 'Aliso Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Covington Care Center', 'geoPoint': {'lat': 33.56504, 'lon': -117.72712}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'West Anaheim Extended Care', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90241', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Downey Regional Medical Center', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Fountain Valley Regional Hospital & Medical Center', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Orange Coast Memorial Medical Center', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Medical Center', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92840', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Chapman Care Center', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92843', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Haven HealthCare Center', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92612', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Regents Point at Windcrest', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92653', 'city': 'Laguna Hills', 'state': 'California', 'country': 'United States', 'facility': 'Saddleback Memorial Medical Center - Laguna Hills', 'geoPoint': {'lat': 33.61252, 'lon': -117.71283}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Long Beach Memorial Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90813', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'St. Mary Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Mission Hospital', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '92658', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '90650', 'city': 'Norwalk', 'state': 'California', 'country': 'United States', 'facility': 'Villa Elena Health Care Center', 'geoPoint': {'lat': 33.90224, 'lon': -118.08173}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '92673', 'city': 'San Clemente', 'state': 'California', 'country': 'United States', 'facility': 'Saddleback Memorial Medical Center - San Clemente', 'geoPoint': {'lat': 33.42697, 'lon': -117.61199}}, {'zip': '90732', 'city': 'San Pedro', 'state': 'California', 'country': 'United States', 'facility': 'Little Company of Mary - San Pedro', 'geoPoint': {'lat': 33.73585, 'lon': -118.29229}}, {'zip': '92707', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Country Villa Plaza', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '92707', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Royale Healthcare', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Memorial Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90732', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Providence Little Company of Mary Medical Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90502', 'city': 'Torrence', 'state': 'California', 'country': 'United States', 'facility': 'Harbor-UCLA Medical Center'}, {'zip': '93003', 'city': 'Ventura', 'state': 'California', 'country': 'United States', 'facility': 'Ventura County Medical Center', 'geoPoint': {'lat': 34.27834, 'lon': -119.29317}}], 'overallOfficials': [{'name': 'Susan S Huang, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irivne - School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Epidemiology and Infection Prevention', 'investigatorFullName': 'Susan Huang', 'investigatorAffiliation': 'University of California, Irvine'}}}}