Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-02-25 @ 9:49 PM
Study NCT ID:
NCT02063867
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Active Bathing to Eliminate Infection (ABATE Infection) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, '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': 'Intervention duration (21 months)', 'eventGroups': [{'id': 'EG000', 'title': 'Arm 1: Usual Care', 'description': 'Routine policy for showering or bathing non-critical care patients', 'otherNumAtRisk': 156889, 'deathsNumAtRisk': 156889, 'otherNumAffected': 0, 'seriousNumAtRisk': 156889, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm 2: Decolonization', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.\n\nArm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.', 'otherNumAtRisk': 183013, 'deathsNumAtRisk': 183013, 'otherNumAffected': 25, 'seriousNumAtRisk': 183013, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diffuse rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diffuse itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild rash on trunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild rash, location unknown', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild rash on limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild rash on limbs, trunk', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild rash on groin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild rash on limbs, face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild rash on limbs, groin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild rash on limbs, trunk, face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild rash on limbs, trunk, groin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild rash on neck, forehead', 'stats': [{'groupId': 'EG000', 'numAtRisk': 156889, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 183013, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'MRSA and VRE Clinical Cultures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156889', 'groupId': 'OG000'}, {'value': '183013', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Usual Care', 'description': 'Routine policy for showering or bathing non-critical care patients'}, {'id': 'OG001', 'title': 'Arm 2: Decolonization', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.\n\nArm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.79', 'upperLimit': '0.95'}, {'value': '0.79', 'groupId': 'OG001', 'lowerLimit': '0.73', 'upperLimit': '0.87'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals'}], 'paramType': 'NUMBER', 'timeFrame': '21 months', 'description': 'Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units. Defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge', 'unitOfMeasure': 'Hazard Ratio (Intervention vs Baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)'}, {'type': 'SECONDARY', 'title': 'Gram-negative Multi-drug Resistant Organism Clinical Cultures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156889', 'groupId': 'OG000'}, {'value': '183013', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Usual Care', 'description': 'Routine policy for showering or bathing non-critical care patients'}, {'id': 'OG001', 'title': 'Arm 2: Decolonization', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.\n\nArm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': '0.91'}, {'value': '0.91', 'groupId': 'OG001', 'lowerLimit': '0.82', 'upperLimit': '1.00'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals'}], 'paramType': 'NUMBER', 'timeFrame': '21 months', 'description': 'Gram-negative (GN) multi-drug resistant organism clinical cultures attributable to participating units. Defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge', 'unitOfMeasure': 'Hazard Ratio (Intervention vs Baseline)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)'}, {'type': 'SECONDARY', 'title': 'All-cause Bloodstream Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156889', 'groupId': 'OG000'}, {'value': '183013', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Usual Care', 'description': 'Routine policy for showering or bathing non-critical care patients'}, {'id': 'OG001', 'title': 'Arm 2: Decolonization', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.\n\nArm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '1.08'}, {'value': '0.90', 'groupId': 'OG001', 'lowerLimit': '0.80', 'upperLimit': '1.01'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals'}], 'paramType': 'NUMBER', 'timeFrame': '21 months', 'description': 'All-cause bloodstream infections attributable to participating units. Defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge. Includes bacterial and yeast pathogens. Skin commensals require two positive blood cultures.', 'unitOfMeasure': 'Hazard Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Unadjusted intention-to-treat analysis. Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Urinary Tract Infections', 'timeFrame': '21 months', 'description': 'Urinary tract infections attributable to participating units. Defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Blood Culture Contamination', 'timeFrame': '21 months', 'description': 'Blood culture contamination', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Clostridium Difficile Infection', 'timeFrame': '21 months', 'description': 'Clostridium difficile Infection attributable to participating units', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': '30-Day Infectious Readmissions', 'timeFrame': '21 months', 'description': '30-Day Infectious Readmissions among patients in participating units', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Emergence of Resistance to Chlorhexidine or Mupirocin', 'timeFrame': '21 months', 'description': 'Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cost Effectiveness', 'timeFrame': '21 months', 'description': 'Cost effectiveness of routine care vs decolonization', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'POST_HOC', 'title': 'MRSA and VRE Clinical Cultures Among Patients With Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15372', 'groupId': 'OG000'}, {'value': '23417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Usual Care', 'description': 'Routine policy for showering or bathing non-critical care patients'}, {'id': 'OG001', 'title': 'Arm 2: Decolonization', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.\n\nArm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.37'}, {'value': '0.80', 'groupId': 'OG001', 'lowerLimit': '0.69', 'upperLimit': '0.92'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals'}], 'paramType': 'NUMBER', 'timeFrame': '21 months', 'description': 'Sub-population analysis: Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units (defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).', 'unitOfMeasure': 'Hazard Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)'}, {'type': 'POST_HOC', 'title': 'MRSA Clinical Cultures Among Patients With Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15372', 'groupId': 'OG000'}, {'value': '23417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Usual Care', 'description': 'Routine policy for showering or bathing non-critical care patients'}, {'id': 'OG001', 'title': 'Arm 2: Decolonization', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.\n\nArm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.17', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '1.39'}, {'value': '0.87', 'groupId': 'OG001', 'lowerLimit': '0.74', 'upperLimit': '1.02'}]}]}], 'analyses': [{'pValue': '0.0126', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Remains significant after adjusting for multiple comparisons', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals'}], 'paramType': 'NUMBER', 'timeFrame': '21 months', 'description': 'Sub-population analysis: Methicillin-resistant Staphylococcus aureus (MRSA) clinical cultures attributable to participating units (defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).', 'unitOfMeasure': 'Hazard Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)'}, {'type': 'POST_HOC', 'title': 'VRE Clinical Cultures Among Patients With Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15372', 'groupId': 'OG000'}, {'value': '23417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Usual Care', 'description': 'Routine policy for showering or bathing non-critical care patients'}, {'id': 'OG001', 'title': 'Arm 2: Decolonization', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.\n\nArm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '0.85', 'upperLimit': '1.86'}, {'value': '0.58', 'groupId': 'OG001', 'lowerLimit': '0.44', 'upperLimit': '0.78'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Remained significant after adjusting for multiple comparisons', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals'}], 'paramType': 'NUMBER', 'timeFrame': '21 months', 'description': 'Sub-population analysis: Vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units (defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains).', 'unitOfMeasure': 'Hazard Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)'}, {'type': 'POST_HOC', 'title': 'All-cause Bloodstream Infections Among Patients With Devices', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15372', 'groupId': 'OG000'}, {'value': '23417', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm 1: Usual Care', 'description': 'Routine policy for showering or bathing non-critical care patients'}, {'id': 'OG001', 'title': 'Arm 2: Decolonization', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.\n\nArm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '0.96', 'upperLimit': '1.33'}, {'value': '0.81', 'groupId': 'OG001', 'lowerLimit': '0.70', 'upperLimit': '0.94'}]}]}], 'analyses': [{'pValue': '0.0032', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Remained significant after adjusting for multiple comparisons', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Assessed if hazard ratio between intervention vs baseline periods differs between study groups, accounting for clustering within hospitals'}], 'paramType': 'NUMBER', 'timeFrame': '21 months', 'description': 'Sub-population analysis: All-cause bloodstream infections attributable to participating units (defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge), among patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Includes bacterial and yeast pathogens. Skin commensals require two positive blood cultures.', 'unitOfMeasure': 'Hazard Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Unadjusted intention-to-treat analysis of sub-population: patients with medical devices (central venous catheters (including accessed ports), midline catheters, or lumbar drains). Number of patients in the intervention period provided. Analysis involves comparison of baseline and intervention patients (difference in differences)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm 1: Usual Care', 'description': 'Routine policy for showering or bathing non-critical care patients'}, {'id': 'FG001', 'title': 'Arm 2: Decolonization', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.\n\nArm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '26', 'numSubjects': '156889'}, {'groupId': 'FG001', 'numUnits': '27', 'numSubjects': '183013'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '24', 'numSubjects': '152598'}, {'groupId': 'FG001', 'numUnits': '24', 'numSubjects': '180048'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '4291'}, {'groupId': 'FG001', 'numUnits': '3', 'numSubjects': '2965'}]}]}], 'typeUnitsAnalyzed': 'hospitals', 'recruitmentDetails': 'The Participant Flow section reflects numbers of hospitals that were enrolled in the intervention (the unit of enrollment and randomization was hospital), as well as the number of participants included in analysis, (the number of patient admissions from participating units in the enrolled hospitals), in each arm during the intervention period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '156889', 'groupId': 'BG000'}, {'value': '183013', 'groupId': 'BG001'}, {'value': '339902', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm 1: Usual Care', 'description': 'Routine policy for showering or bathing non-critical care patients'}, {'id': 'BG001', 'title': 'Arm 2: Decolonization', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.\n\nArm 2: Decolonization: Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '156889', 'groupId': 'BG000'}, {'value': '183013', 'groupId': 'BG001'}, {'value': '339902', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62.3', 'spread': '18.2', 'groupId': 'BG000'}, {'value': '62.6', 'spread': '18.6', 'groupId': 'BG001'}, {'value': '62.4', 'spread': '18.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '156873', 'groupId': 'BG000'}, {'value': '182997', 'groupId': 'BG001'}, {'value': '339870', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '84585', 'groupId': 'BG000'}, {'value': '100249', 'groupId': 'BG001'}, {'value': '184834', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72288', 'groupId': 'BG000'}, {'value': '82748', 'groupId': 'BG001'}, {'value': '155036', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data not available for 32 patients during the intervention period.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156889', 'groupId': 'BG000'}, {'value': '183013', 'groupId': 'BG001'}, {'value': '339902', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '107261', 'groupId': 'BG000'}, {'value': '112067', 'groupId': 'BG001'}, {'value': '219328', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156889', 'groupId': 'BG000'}, {'value': '183013', 'groupId': 'BG001'}, {'value': '339902', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22581', 'groupId': 'BG000'}, {'value': '38704', 'groupId': 'BG001'}, {'value': '61285', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156889', 'groupId': 'BG000'}, {'value': '183013', 'groupId': 'BG001'}, {'value': '339902', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21501', 'groupId': 'BG000'}, {'value': '22462', 'groupId': 'BG001'}, {'value': '43963', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156889', 'groupId': 'BG000'}, {'value': '183013', 'groupId': 'BG001'}, {'value': '339902', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2021', 'groupId': 'BG000'}, {'value': '4175', 'groupId': 'BG001'}, {'value': '6196', 'groupId': 'BG002'}]}]}, {'title': 'Other/Unknown', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156889', 'groupId': 'BG000'}, {'value': '183013', 'groupId': 'BG001'}, {'value': '339902', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3525', 'groupId': 'BG000'}, {'value': '5605', 'groupId': 'BG001'}, {'value': '9130', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156889', 'groupId': 'BG000'}, {'value': '183013', 'groupId': 'BG001'}, {'value': '339902', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '156889', 'groupId': 'BG000'}, {'value': '183013', 'groupId': 'BG001'}, {'value': '339902', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'These numbers reflect the number of participants in the baseline period across all participating facilities enrolled.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-06-30', 'size': 1710404, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-05-29T15:29', 'hasProtocol': True}, {'date': '2015-06-30', 'size': 169285, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-05-29T15:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-14', 'studyFirstSubmitDate': '2014-02-12', 'resultsFirstSubmitDate': '2019-04-29', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-14', 'studyFirstPostDateStruct': {'date': '2014-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Urinary Tract Infections', 'timeFrame': '21 months', 'description': 'Urinary tract infections attributable to participating units. Defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge'}, {'measure': 'Blood Culture Contamination', 'timeFrame': '21 months', 'description': 'Blood culture contamination'}, {'measure': 'Clostridium Difficile Infection', 'timeFrame': '21 months', 'description': 'Clostridium difficile Infection attributable to participating units'}, {'measure': '30-Day Infectious Readmissions', 'timeFrame': '21 months', 'description': '30-Day Infectious Readmissions among patients in participating units'}, {'measure': 'Emergence of Resistance to Chlorhexidine or Mupirocin', 'timeFrame': '21 months', 'description': 'Emergence of resistance to chlorhexidine (among MRSA and select gram-negative bacteria) or mupirocin (among MRSA) for strains isolated from participating units'}, {'measure': 'Cost Effectiveness', 'timeFrame': '21 months', 'description': 'Cost effectiveness of routine care vs decolonization'}], 'primaryOutcomes': [{'measure': 'MRSA and VRE Clinical Cultures', 'timeFrame': '21 months', 'description': 'Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant enterococci (VRE) clinical cultures attributable to participating units. Defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge'}], 'secondaryOutcomes': [{'measure': 'Gram-negative Multi-drug Resistant Organism Clinical Cultures', 'timeFrame': '21 months', 'description': 'Gram-negative (GN) multi-drug resistant organism clinical cultures attributable to participating units. Defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge'}, {'measure': 'All-cause Bloodstream Infections', 'timeFrame': '21 months', 'description': 'All-cause bloodstream infections attributable to participating units. Defined as occurring \\>2 days into a participating unit stay through 2 days following unit discharge. Includes bacterial and yeast pathogens. Skin commensals require two positive blood cultures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HAI', 'MRSA', 'VRE'], 'conditions': ['Healthcare Associated Infections', 'Methicillin Resistant Staphylococcus Aureus', 'Multi Drug Resistant Organisms']}, 'referencesModule': {'references': [{'pmid': '30850112', 'type': 'DERIVED', 'citation': 'Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Heim L, Gombosev A, Avery TR, Haffenreffer K, Shimelman L, Hayden MK, Weinstein RA, Spencer-Smith C, Kaganov RE, Murphy MV, Forehand T, Lankiewicz J, Coady MH, Portillo L, Sarup-Patel J, Jernigan JA, Perlin JB, Platt R; ABATE Infection trial team. Chlorhexidine versus routine bathing to prevent multidrug-resistant organisms and all-cause bloodstream infections in general medical and surgical units (ABATE Infection trial): a cluster-randomised trial. Lancet. 2019 Mar 23;393(10177):1205-1215. doi: 10.1016/S0140-6736(18)32593-5. Epub 2019 Mar 5.'}, {'pmid': '26772801', 'type': 'DERIVED', 'citation': 'Johnson KE, Neta G, Dember LM, Coronado GD, Suls J, Chambers DA, Rundell S, Smith DH, Liu B, Taplin S, Stoney CM, Farrell MM, Glasgow RE. Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory. Trials. 2016 Jan 16;17:32. doi: 10.1186/s13063-016-1158-y.'}]}, 'descriptionModule': {'briefSummary': 'The ABATE Infection Project is a cluster randomized trial of hospitals to compare two quality improvement strategies to reduce multi-drug resistant organisms and healthcare-associated infections in non-critical care units. The two strategies to be evaluated are:\n\n* Arm 1: Routine Care Routine policy for showering/bathing\n* Arm 2: Decolonization Use of chlorhexidine as routine soap for showering or bed bathing for all patients Mupirocin x 5 days if MRSA+ by history, culture, or screen\n\nNote that enrolled "subjects" represents 53 individual HCA Hospitals (representing \\~190 non-critical care units) that have been randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All HCA hospitals that reside in the United States\n* Note: Unit of randomization is the hospital, but the participants are hospital units\n\nExclusion Criteria:\n\n* Non-critical care units where chlorhexidine bathing or decolonization for MRSA+ non-critical care patients is routine\n* Pediatric, peri-partum, rehabilitation, psychiatry, and BMT units\n* Units with \\>30% cardiac or hip/knee orthopedic surgeries\n* Unit average length of stay \\<2 days\n* Patients \\<12 years-old\n* Patients with known allergy to mupirocin or chlorhexidine'}, 'identificationModule': {'nctId': 'NCT02063867', 'acronym': 'ABATE', 'briefTitle': 'Active Bathing to Eliminate Infection (ABATE Infection) Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Cluster-Randomized Controlled Trial of Hospitals to Reduce Healthcare-Associated Infections and Readmissions Through Routine Bathing With Antiseptic Soap and Targeted Use of Nasal Antibiotic Ointment (ABATE Infection Trial)', 'orgStudyIdInfo': {'id': '367981'}, 'secondaryIdInfos': [{'id': 'UH2AT007769', 'link': 'https://reporter.nih.gov/quickSearch/UH2AT007769', 'type': 'NIH'}, {'id': 'UH3AI113337', 'link': 'https://reporter.nih.gov/quickSearch/UH3AI113337', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm 1: Usual Care', 'description': 'Routine policy for showering or bathing non-critical care patients'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2: Decolonization', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.', 'interventionNames': ['Drug: Arm 2: Decolonization']}], 'interventions': [{'name': 'Arm 2: Decolonization', 'type': 'DRUG', 'description': 'Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.\n\nTopical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen.', 'armGroupLabels': ['Arm 2: Decolonization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91307', 'city': 'West Hills', 'state': 'California', 'country': 'United States', 'facility': 'West Hills Hospital & Medical Center', 'geoPoint': {'lat': 34.19731, 'lon': -118.64398}}, {'zip': '80229', 'city': 'Thornton', 'state': 'Colorado', 'country': 'United States', 'facility': 'North Suburban Medical Center', 'geoPoint': {'lat': 39.86804, 'lon': -104.97192}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Blake Medical Center', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '34741', 'city': 'Kissimmee', 'state': 'Florida', 'country': 'United States', 'facility': 'Osceola Regional Medical Center', 'geoPoint': {'lat': 28.30468, 'lon': -81.41667}}, {'zip': '33470', 'city': 'Loxahatchee Groves', 'state': 'Florida', 'country': 'United States', 'facility': 'Palms West Hospital', 'geoPoint': {'lat': 26.68368, 'lon': -80.27977}}, {'zip': '32073', 'city': 'Orange Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Orange Park Medical Center', 'geoPoint': {'lat': 30.16607, 'lon': -81.70648}}, {'zip': '32514', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': 'West Florida Hospital', 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Northside Hospital', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33710', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'St. Petersburg General Hospital', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33573', 'city': 'Sun City Center', 'state': 'Florida', 'country': 'United States', 'facility': 'South Bay Hospital', 'geoPoint': {'lat': 27.71809, 'lon': -82.35176}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'West Palm Hospital', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30120', 'city': 'Cartersville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Cartersville Medical Center', 'geoPoint': {'lat': 34.16533, 'lon': -84.80231}}, {'zip': '31210', 'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'facility': 'Coliseum Northside Hospital', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'zip': '30078', 'city': 'Snellville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Eastside Medical Center', 'geoPoint': {'lat': 33.85733, 'lon': -84.01991}}, {'zip': '66215', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Overland Park Regional Medical Center', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '70506', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Regional Medical Center of Acadiana', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '39503', 'city': 'Gulfport', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Garden Park Medical Center', 'geoPoint': {'lat': 30.36742, 'lon': -89.09282}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Medical Center', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64063', 'city': "Lee's Summit", 'state': 'Missouri', 'country': 'United States', 'facility': "Lee's Summit Medical Center", 'geoPoint': {'lat': 38.91084, 'lon': -94.38217}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sunrise Hospital and Medical Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'MountainView Hospital-Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '03038', 'city': 'Derry', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Parkland Medical Center', 'geoPoint': {'lat': 42.88064, 'lon': -71.32729}}, {'zip': '03801', 'city': 'Portsmouth', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Portsmouth Regional Hospital', 'geoPoint': {'lat': 43.07704, 'lon': -70.75766}}, {'zip': '29488', 'city': 'Walterboro', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Colleton Medical Center', 'geoPoint': {'lat': 32.90517, 'lon': -80.66677}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Parkridge Medical Center', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37412', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Parkridge East Hospital', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37055', 'city': 'Dickson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'TriStar Horizon Medical Center', 'geoPoint': {'lat': 36.077, 'lon': -87.38779}}, {'zip': '37075', 'city': 'Hendersonville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Hendersonville Medical Center', 'geoPoint': {'lat': 36.30477, 'lon': -86.62}}, {'zip': '37076', 'city': 'Hermitage', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Summit Medical Center', 'geoPoint': {'lat': 36.19617, 'lon': -86.6225}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': "St. David's Medical Center", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78526', 'city': 'Brownsville', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Regional Medical Center', 'geoPoint': {'lat': 25.90175, 'lon': -97.49748}}, {'zip': '77304', 'city': 'Conroe', 'state': 'Texas', 'country': 'United States', 'facility': 'Conroe Regional Medical Center', 'geoPoint': {'lat': 30.31188, 'lon': -95.45605}}, {'zip': '78411', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Corpus Christi Medical Center', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '79902', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Las Palmas Medical Center', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Plaza Medical Center of Fort Worth', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '75039', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'Las Colinas Medical Center', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '77339', 'city': 'Kingwood', 'state': 'Texas', 'country': 'United States', 'facility': 'Kingwood Medical Center', 'geoPoint': {'lat': 30.05691, 'lon': -95.18349}}, {'zip': '78233', 'city': 'Live Oak', 'state': 'Texas', 'country': 'United States', 'facility': 'Northeast Methodist Hospital', 'geoPoint': {'lat': 29.56523, 'lon': -98.3364}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Rio Grande Regional Hospital', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '76180', 'city': 'North Richland Hills', 'state': 'Texas', 'country': 'United States', 'facility': 'North Hills Hospital', 'geoPoint': {'lat': 32.8343, 'lon': -97.2289}}, {'zip': '75075', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'Medical Center of Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '78201', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Texsan Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Specialty and Transplant Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Stone Oak Hospital', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '77598', 'city': 'Webster', 'state': 'Texas', 'country': 'United States', 'facility': 'Clear Lake Regional Medical Center', 'geoPoint': {'lat': 29.53773, 'lon': -95.11826}}, {'zip': '84057', 'city': 'Orem', 'state': 'Utah', 'country': 'United States', 'facility': 'Timpanogos Regional Hospital', 'geoPoint': {'lat': 40.2969, 'lon': -111.69465}}, {'zip': '23860', 'city': 'Hopewell', 'state': 'Virginia', 'country': 'United States', 'facility': 'John Randolph Medical Center', 'geoPoint': {'lat': 37.30432, 'lon': -77.2872}}, {'zip': '24457', 'city': 'Low Moor', 'state': 'Virginia', 'country': 'United States', 'facility': 'LewisGale Hospital-Alleghany', 'geoPoint': {'lat': 37.78874, 'lon': -79.88366}}, {'zip': '20190', 'city': 'Reston', 'state': 'Virginia', 'country': 'United States', 'facility': 'Reston Hospital Center', 'geoPoint': {'lat': 38.96872, 'lon': -77.3411}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Chippenham Johnston Willis Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '23229', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': "Henrico Doctors' Hospital", 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Susan Huang, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}, {'name': 'Ken Kleinman, ScD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Massachusetts, Amherst'}, {'name': 'Edward Septimus, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Corporation of America'}, {'name': 'Jason Hickok, MBA, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Corporation of America'}, {'name': 'Julia Moody, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Corporation of America'}, {'name': 'Mary Hayden, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rush University'}, {'name': 'Robert Weinstein, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'John Stroger Hospital'}, {'name': 'John Jernigan, MD MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centers for Disease Control and Prevention'}, {'name': 'Jonathan Perlin, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Corporation of America'}, {'name': 'Daniel Gillen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of California, Irvine'}, {'name': 'Grace Lee, MD MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Harvard Pilgrim Health Care Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}, {'name': 'Harvard Pilgrim Health Care', 'class': 'OTHER'}, {'name': 'Hospital Corporation of America', 'class': 'INDUSTRY'}, {'name': 'Rush University', 'class': 'OTHER'}, {'name': 'Cook County Health', 'class': 'OTHER_GOV'}, {'name': 'Centers for Disease Control and Prevention', 'class': 'FED'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor and Medical Director of Epidemiology and Infection Prevention', 'investigatorFullName': 'Susan Huang', 'investigatorAffiliation': 'University of California, Irvine'}}}}