Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT04210505
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-28
First Post:
2019-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nasal Decolonization of Dialysis Patients Noses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-18', 'mcpReleaseN': 6, 'releaseDate': '2025-03-27'}], 'estimatedResultsFirstSubmitDate': '2025-03-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013203', 'term': 'Staphylococcal Infections'}], 'ancestors': [{'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-31', 'size': 271870, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-13T11:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 302}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-26', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2019-12-20', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Staphylococcus aureus bloodstream infection', 'timeFrame': 'Through study completion (up to 3 years)', 'description': 'Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: a Staphylococcus aureus positive blood specimen collected in the outpatient setting or within 1 calendar day after a hospital admission'}], 'secondaryOutcomes': [{'measure': 'Incidence of Staphylococcus aureus access related bloodstream infection (ARBSI)', 'timeFrame': 'Through study completion (up to 3 years)', 'description': 'Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: a Staphylococcus aureus bloodstream infection with the suspected source reported as the vascular access or uncertain'}, {'measure': 'Incidence of Staphylococcus aureus local access site infection', 'timeFrame': 'Through study completion (up to 3 years)', 'description': 'Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: pus, redness or increased swelling at the vascular access site when an ARBSI is not present but with positive culture for Staphylococcus aureus'}, {'measure': 'Incidence of Bloodstream infections by any pathogen', 'timeFrame': 'Through study completion (up to 3 years)', 'description': 'Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network definition: a positive blood specimen collected in the outpatient setting or within 1 calendar day after a hospital admission'}, {'measure': 'Incidence of Access related bloodstream infection by any pathogen', 'timeFrame': 'Through study completion (up to 3 years)', 'description': 'Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network definition: a bloodstream infection with the suspected source reported as the vascular access or uncertain'}, {'measure': 'Incidence of Local access site infection', 'timeFrame': 'Through study completion (up to 3 years)', 'description': 'Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definition: pus, redness or increased swelling at the vascular access site when an ARBSI is not present'}, {'measure': 'Incidence of Staphylococcus aureus bloodstream infection among patients who agreed to participate in intervention', 'timeFrame': 'Through study completion (up to 3 years)', 'description': 'Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dialysis', 'povidone-iodine'], 'conditions': ['Staphylococcus Aureus Infection']}, 'referencesModule': {'references': [{'pmid': '34862278', 'type': 'DERIVED', 'citation': "Racila AM, O'Shea AMJ, Nair R, Dukes K, Herwaldt LA, Boyken L, Diekema D, Ward MA, Cobb J, Jacob J, Pegues D, Bleasdale S, Vijayan A, Mutneja A, Fraer M, O'Connell-Moore D, Tolomeo P, Mendez M, Jaworski E, Schweizer ML. Using nasal povidone-iodine to prevent bloodstream infections and transmission of Staphylococcus aureus among haemodialysis patients: a stepped-wedge cluster randomised control trial protocol. BMJ Open. 2021 Dec 3;11(12):e048830. doi: 10.1136/bmjopen-2021-048830."}]}, 'descriptionModule': {'briefSummary': 'Hemodialysis patients are at high-risk for infections, specifically Staphylococcus aureus infections. The investigators propose to 1) implement a novel intervention (nasal povidone-iodine at each hemodialysis session) to prevent S. aureus infections using a stepped-wedge cluster randomized trial, and 2) evaluate the feasibility and acceptability of this intervention. If successful, this intervention can be used among hemodialysis patients, and evaluated in other high-risk patient populations to prevent S. aureus infections.', 'detailedDescription': 'The PAINTS study is a stepped-wedge cluster randomized trial that will compare standard care to an intervention that includes nasal povidone-iodine at each hemodialysis session to determine whether nasal povidone-iodine prevents infections. The nasal povidone-iodine will be donated by 3M. This formulation of nasal povidone-iodine was developed under the Tentative Final Monograph for Health-Care Antiseptic Drug Products 21 CFR Parts 333 and 369 (Docket # 75N-183H), Federal Register Volume 59, Number 116, Friday, June 17, 1994, Proposed Rules. However, the product need not be controlled like a pharmaceutical drug. The product may be stored and controlled similarly to an iodine or alcohol skin preparation product.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients receiving outpatient chronic hemodialysis at one of the 16 study dialysis centers.\n\nNote: the unit of randomization is the dialysis center, not the individual patient\n\nExclusion Criteria:\n\nPatients receiving peritoneal dialysis or home hemodialysis Pregnant women Patients with known sensitivity or allergy to iodine (documented or verbalized) Patients with active bacterial infections Children \\< 18 years of age. Patients with infections at the beginning of the study will enter the study after antibiotic treatment is complete.'}, 'identificationModule': {'nctId': 'NCT04210505', 'acronym': 'PAINTS', 'briefTitle': 'Nasal Decolonization of Dialysis Patients Noses', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Povidone-iodine to Stop Access-related Infections and Transmission of Staphylococcus Aureus (PAINTS)', 'orgStudyIdInfo': {'id': 'Pending'}, 'secondaryIdInfos': [{'id': '1R01HS026724', 'link': 'https://reporter.nih.gov/quickSearch/1R01HS026724', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasal Povidone-Iodine Decolonization Intervention', 'description': "Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session.", 'interventionNames': ['Drug: Povidone-Iodine Topical Ointment', 'Other: Standard Care']}, {'type': 'NO_INTERVENTION', 'label': 'Concurrent Control', 'description': 'Standard of Care. This will be usual care at each hemodialysis center.'}], 'interventions': [{'name': 'Povidone-Iodine Topical Ointment', 'type': 'DRUG', 'description': 'Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing hemodialysis before each session.', 'armGroupLabels': ['Nasal Povidone-Iodine Decolonization Intervention']}, {'name': 'Standard Care', 'type': 'OTHER', 'description': 'Control group will receive standard care as provided by the dialysis center', 'armGroupLabels': ['Nasal Povidone-Iodine Decolonization Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Healthcare', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Marin L Schweizer, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Until year 2025', 'ipdSharing': 'YES', 'description': 'The investigators will submit an electronic version of each peer-reviewed accepted manuscript to PubMed Central to be made publicly available within 12 months of publication. The investigators will respond to requests for restricted public health data sets and ensure responses follow appropriate processes, documentation, and approval.', 'accessCriteria': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marin L. Schweizer, PhD', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, {'name': 'Emory Healthcare', 'class': 'OTHER'}, {'name': 'Agency for Healthcare Research and Quality (AHRQ)', 'class': 'FED'}, {'name': '3M', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marin L. Schweizer, PhD', 'investigatorAffiliation': 'University of Iowa'}}}}