Nasal Decolonization of Dialysis Patients Noses (PAINTS)

Povidone-iodine to Stop Access-related Infections and Transmission of Staphylococcus Aureus (PAINTS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Staphylococcus Aureus Infection
• Intervention / Treatment: Drug: Povidone-Iodine Topical Ointment; Other: Standard Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Healthcare
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients receiving outpatient chronic hemodialysis at one of the 16 study dialysis centers.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal Povidone-Iodine Decolonization Intervention; Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session.	Drug: Povidone-Iodine Topical Ointment; Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing hemodialysis before each session.; Other: Standard Care; Control group will receive standard care as provided by the dialysis center
No Intervention: Concurrent Control; Standard of Care. This will be usual care at each hemodialysis center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Marin L. Schweizer, PhD
• Collaborators: University of Pennsylvania; Washington University School of Medicine; University of Illinois at Chicago; Agency for Healthcare Research and Quality (AHRQ); 3M; Emory Healthcare
• Investigators: Principal Investigator: Marin L Schweizer, PhD, University of Wisconsin, Madison

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2020
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Dialysis; povidone-iodine
• Additional Relevant MeSH Terms: Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Staphylococcal Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Plasma Substitutes; Blood Substitutes; Povidone-Iodine; Povidone
• Other Study ID Numbers: Pending (Clinical Research Information Service); 1R01HS026724 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.
• IPD Sharing Time Frame: Until year 2025
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No