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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HS026724 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| University of Illinois at Chicago | OTHER |
| Washington University School of Medicine | OTHER |
| Emory Healthcare |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Povidone-Iodine Decolonization Intervention | Experimental | Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session. |
|
| Concurrent Control | No Intervention | Standard of Care. This will be usual care at each hemodialysis center. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-Iodine Topical Ointment | Drug | Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing hemodialysis before each session. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Staphylococcus aureus bloodstream infection | 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 | Through study completion (up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Staphylococcus aureus access related bloodstream infection (ARBSI) | 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 | Through study completion (up to 3 years) |
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Inclusion Criteria:
Note: the unit of randomization is the dialysis center, not the individual patient
Exclusion Criteria:
Patients 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.
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| Name | Affiliation | Role |
|---|---|---|
| Marin L Schweizer, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Healthcare | Atlanta | Georgia | 30322 | United States | ||
| University of Illinois Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41635193 | Derived | Armstrong-Pavlik F, Racila AM, Ward M, Nair R, Tolomeo P, Kellogg J, Lindsey B, Herwaldt LA, Jacob JT, Vijayan A, Pegues D, Cobb J, Fraer M, Casey SB, Dukes KC, Hockett Sherlock S, Hopps M, Schweizer ML. Survey of hemodialysis patients' knowledge of their infection risk and acceptability of an intranasal decolonization intervention. Infect Control Hosp Epidemiol. 2026 Mar;47(3):252-256. doi: 10.1017/ice.2025.10386. Epub 2026 Feb 4. | |
| 34862278 | Derived |
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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.
Until year 2025
Upon request
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 31, 2022 | Mar 13, 2023 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 27, 2025 | Apr 18, 2025 | 6 |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
| 3M | INDUSTRY |
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| Standard Care | Other | Control group will receive standard care as provided by the dialysis center |
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| Incidence of Staphylococcus aureus local access site infection |
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 |
| Through study completion (up to 3 years) |
| Incidence of Bloodstream infections by any pathogen | 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 | Through study completion (up to 3 years) |
| Incidence of Access related bloodstream infection by any pathogen | 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 | Through study completion (up to 3 years) |
| Incidence of Local access site infection | 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 | Through study completion (up to 3 years) |
| Incidence of Staphylococcus aureus bloodstream infection among patients who agreed to participate in intervention | Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network | Through study completion (up to 3 years) |
| Chicago |
| Illinois |
| 60612 |
| United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| 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. |