Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-03-19 @ 1:25 AM
Study NCT ID:
NCT03118232
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2017-02-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010882', 'term': 'chlorhexidine gluconate'}, {'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D011206', 'term': 'Povidone-Iodine'}], 'ancestors': [{'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sshuang@hs.uci.edu', 'phone': '714-456-5047', 'title': 'Dr. Susan Huang', 'organization': 'University of California, Irvine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '18 months', 'eventGroups': [{'id': 'EG000', 'title': 'Decolonization', 'description': 'Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.\n\nChlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.\n\nIodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.', 'otherNumAtRisk': 7388, 'deathsNumAtRisk': 7388, 'otherNumAffected': 35, 'seriousNumAtRisk': 7388, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Routine Bathing', 'description': 'Routine bathing per facility protocol.', 'otherNumAtRisk': 6564, 'deathsNumAtRisk': 6564, 'otherNumAffected': 0, 'seriousNumAtRisk': 6564, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7388, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 6564, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7388, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6564, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hospital Transfers Due to Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7388', 'groupId': 'OG000'}, {'value': '6564', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Decolonization', 'description': 'Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.\n\nChlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.\n\nIodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.'}, {'id': 'OG001', 'title': 'Routine Bathing', 'description': 'Routine bathing per facility protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '1243', 'groupId': 'OG000'}, {'value': '1780', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Risk Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.6', 'ciLowerLimit': '11.0', 'ciUpperLimit': '21.8', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.'}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Probability that a transfer to a hospital is due to an infection', 'unitOfMeasure': 'Transfers', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is of residents accounting for clustering in 28 nursing homes'}, {'type': 'SECONDARY', 'title': 'All Hospital Transfers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7388', 'groupId': 'OG000'}, {'value': '6564', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Decolonization', 'description': 'Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.\n\nChlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.\n\nIodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.'}, {'id': 'OG001', 'title': 'Routine Bathing', 'description': 'Routine bathing per facility protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '2388', 'groupId': 'OG000'}, {'value': '2857', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Risk Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.6', 'ciLowerLimit': '9.7', 'ciUpperLimit': '19.2', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk ratios reflect the risk of transfer to a hospital during the intervention period relative to the baseline period in each trial group.'}], 'paramType': 'NUMBER', 'timeFrame': '18 months', 'description': 'Probability that a discharge is to a hospital', 'unitOfMeasure': 'Transfers', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis is of residents accounting for clustering in 28 nursing homes'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '550', 'groupId': 'OG000'}, {'value': '650', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Decolonization', 'description': 'Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.\n\nChlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.\n\nIodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.'}, {'id': 'OG001', 'title': 'Routine Bathing', 'description': 'Routine bathing per facility protocol.'}], 'classes': [{'categories': [{'measurements': [{'value': '176', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Once in baseline and once at end-intervention (month 15-18 of intervention period)', 'description': 'Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hospital Transfers Due to Infection in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)', 'timeFrame': '18 months', 'description': 'Probability that a transfer to a hospital is due to an infection for long stay and short stay resident subsets', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'All Hospital Transfers in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)', 'timeFrame': '18 months', 'description': 'Probability that a discharge is to a hospital for long stay and short stay resident subsets', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Emergency Department Transfers Due to Infection (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)', 'timeFrame': '18 months', 'description': 'Probability that a resident is sent to the emergency department for an infection, overall for long stay and short stay resident subsets', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Decolonization', 'description': 'Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.\n\nChlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.\n\nIodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.'}, {'id': 'FG001', 'title': 'Routine Bathing', 'description': 'Routine bathing per facility protocol.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '7388'}, {'groupId': 'FG001', 'numUnits': '14', 'numSubjects': '6564'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '7388'}, {'groupId': 'FG001', 'numUnits': '14', 'numSubjects': '6564'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Nursing Homes'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7388', 'groupId': 'BG000'}, {'value': '6564', 'groupId': 'BG001'}, {'value': '13952', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Decolonization', 'description': 'Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.\n\nChlorhexidine gluconate (CHG): 2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.\n\nIodophor (10% povidone-iodine): Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.'}, {'id': 'BG001', 'title': 'Routine Bathing', 'description': 'Routine bathing per facility protocol.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '75.7', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '76.6', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '76.2', 'spread': '5.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4180', 'groupId': 'BG000'}, {'value': '3602', 'groupId': 'BG001'}, {'value': '7782', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3208', 'groupId': 'BG000'}, {'value': '2962', 'groupId': 'BG001'}, {'value': '6170', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1042', 'groupId': 'BG000'}, {'value': '1312', 'groupId': 'BG001'}, {'value': '2354', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '841', 'groupId': 'BG000'}, {'value': '1042', 'groupId': 'BG001'}, {'value': '1883', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3749', 'groupId': 'BG000'}, {'value': '2666', 'groupId': 'BG001'}, {'value': '6415', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1756', 'groupId': 'BG000'}, {'value': '1544', 'groupId': 'BG001'}, {'value': '3300', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7388', 'groupId': 'BG000'}, {'value': '6564', 'groupId': 'BG001'}, {'value': '13952', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-08-10', 'size': 11310952, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-09T13:20', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13952}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2017-02-21', 'resultsFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2017-04-14', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-05', 'studyFirstPostDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Multidrug-resistant Organism (MDRO) Colonization (Secondary Manuscript)', 'timeFrame': 'Once in baseline and once at end-intervention (month 15-18 of intervention period)', 'description': 'Probability of colonization with any multidrug-resistant organism (MDRO): (MRSA, VRE, ESBL, CRE)'}, {'measure': 'Hospital Transfers Due to Infection in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)', 'timeFrame': '18 months', 'description': 'Probability that a transfer to a hospital is due to an infection for long stay and short stay resident subsets'}, {'measure': 'All Hospital Transfers in Long Stay and Short Stay Subsets (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)', 'timeFrame': '18 months', 'description': 'Probability that a discharge is to a hospital for long stay and short stay resident subsets'}, {'measure': 'Emergency Department Transfers Due to Infection (Secondary Manuscript, Added by Steering Committee Decision on 3/22/2017)', 'timeFrame': '18 months', 'description': 'Probability that a resident is sent to the emergency department for an infection, overall for long stay and short stay resident subsets'}], 'primaryOutcomes': [{'measure': 'Hospital Transfers Due to Infection', 'timeFrame': '18 months', 'description': 'Probability that a transfer to a hospital is due to an infection'}], 'secondaryOutcomes': [{'measure': 'All Hospital Transfers', 'timeFrame': '18 months', 'description': 'Probability that a discharge is to a hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nursing Homes', 'Health Facilities', 'Infections', 'Readmissions', 'Multi-Drug resistance', 'Antibiotic Use'], 'conditions': ['Hospitalization', 'Infection']}, 'referencesModule': {'references': [{'pmid': '37815935', 'type': 'DERIVED', 'citation': 'Miller LG, McKinnell JA, Singh RD, Gussin GM, Kleinman K, Saavedra R, Mendez J, Catuna TD, Felix J, Chang J, Heim L, Franco R, Tjoa T, Stone ND, Steinberg K, Beecham N, Montgomery J, Walters D, Park S, Tam S, Gohil SK, Robinson PA, Estevez M, Lewis B, Shimabukuro JA, Tchakalian G, Miner A, Torres C, Evans KD, Bittencourt CE, He J, Lee E, Nedelcu C, Lu J, Agrawal S, Sturdevant SG, Peterson E, Huang SS. Decolonization in Nursing Homes to Prevent Infection and Hospitalization. N Engl J Med. 2023 Nov 9;389(19):1766-1777. doi: 10.1056/NEJMoa2215254. Epub 2023 Oct 10.'}]}, 'descriptionModule': {'briefSummary': 'This is a cluster-randomized trial of nursing homes to assess whether decolonization with routine chlorhexidine bathing and periodic use of nasal antiseptics can reduce hospitalizations associated with infections, antibiotic utilization, and multi-drug resistant organism (MDRO) prevalence. The comparator arm will be routine bathing care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nNursing homes will be eligible to participate if they meet the following criteria:\n\n* Licensed nursing home in Orange County or Southern Los Angeles County serving adults\n* Minimal use of chlorhexidine bathing\\*\n* Minimal use of nasal decolonization\\* \\*Minimal use defined as \\<15% of residents receiving at least one chlorhexidine bath or nasal decolonization treatment during their nursing home stay.\n\nExclusion Criteria\n\nNursing homes will not be eligible to participate if they meet the following criteria:\n\n* Facilities routinely using decolonization\n* Dedicated psychiatric nursing homes\n* Facilities with a resident population with \\>=20% combative patients\n* Pediatric facilities\n\nNote: in any participating nursing home, residents with active end-of-life comfort care only measures are excluded'}, 'identificationModule': {'nctId': 'NCT03118232', 'acronym': 'PROTECT', 'briefTitle': 'Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Project PROTECT: Protecting Nursing Homes From Infections and Hospitalization', 'orgStudyIdInfo': {'id': '20151805'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Decolonization', 'description': 'Nursing homes assigned to this arm will perform decolonization using topical antiseptic products.', 'interventionNames': ['Drug: Chlorhexidine gluconate (CHG)', 'Drug: Iodophor (10% povidone-iodine)']}, {'type': 'NO_INTERVENTION', 'label': 'Routine Bathing', 'description': 'Routine bathing per facility protocol.'}], 'interventions': [{'name': 'Chlorhexidine gluconate (CHG)', 'type': 'DRUG', 'description': '2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.', 'armGroupLabels': ['Decolonization']}, {'name': 'Iodophor (10% povidone-iodine)', 'type': 'DRUG', 'description': 'Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.', 'armGroupLabels': ['Decolonization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92802', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Buena Vista Care Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92802', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Walnut Village Rehabilitation and Care Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Crest Nursing Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Sun Mar Nursing Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92804', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'West Anaheim Extended Care', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'Bel Tooren Villa Convalescent Hospital', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '92624', 'city': 'Capistrano Beach', 'state': 'California', 'country': 'United States', 'facility': 'Capistrano Beach Care Center', 'geoPoint': {'lat': 33.46253, 'lon': -117.67172}}, {'zip': '90242', 'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Downey Care Center', 'geoPoint': {'lat': 33.94001, 'lon': -118.13257}}, {'zip': '92831', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Gordon Lane Care Center', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92832', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Windsor Gardens Care Center of Fullerton', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Terrace View Care Center', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '92843', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Haven Subacute Healthcare Center', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90249', 'city': 'Gardena', 'state': 'California', 'country': 'United States', 'facility': 'Las Flores Convalescent Hospital', 'geoPoint': {'lat': 33.88835, 'lon': -118.30896}}, {'zip': '90631', 'city': 'La Habra', 'state': 'California', 'country': 'United States', 'facility': 'Park Regency Care Center', 'geoPoint': {'lat': 33.93196, 'lon': -117.94617}}, {'zip': '90804', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Regency Oaks Post Acute Care Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90805', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Windsor Convalescent of North Long Beach', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Bixby Knolls Healthcare Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Villa Inc.', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90807', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Vista Cove Care Center at Long Beach', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90815', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Intercommunity Care Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90262', 'city': 'Lynwood', 'state': 'California', 'country': 'United States', 'facility': 'Royal Oaks Care Center', 'geoPoint': {'lat': 33.93029, 'lon': -118.21146}}, {'zip': '90650', 'city': 'Norwalk', 'state': 'California', 'country': 'United States', 'facility': 'Norwalk Skilled Nursing and Wellness Center', 'geoPoint': {'lat': 33.90224, 'lon': -118.08173}}, {'zip': '90650', 'city': 'Norwalk', 'state': 'California', 'country': 'United States', 'facility': 'Villa Elena Care Center', 'geoPoint': {'lat': 33.90224, 'lon': -118.08173}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Harbor Post-Acute Care Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Heritage Rehabilitation Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Sunnyside Nursing Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90503', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Care Center West', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '90505', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Del Amo Gardens Care Center', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}], 'overallOfficials': [{'name': 'Susan Huang, MD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}, {'name': 'Loren Miller, MD MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Harbor UCLA'}, {'name': 'James McKinnell, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Harbor UCLA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The resource sharing plan involves sharing 1) sharing of trial materials and tools, and 2) making bacterial isolates available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center', 'class': 'OTHER'}, {'name': 'University of Massachusetts, Amherst', 'class': 'OTHER'}, {'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Medical Director of Epidemiology and Infection Prevention', 'investigatorFullName': 'Susan Huang', 'investigatorAffiliation': 'University of California, Irvine'}}}}