Nasal Decolonization of Dialysis Patients Noses

Overview

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.

Full Title of Study: “Povidone-iodine to Stop Access-related Infections and Transmission of Staphylococcus Aureus (PAINTS)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 28, 2023

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • 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.
  • No Intervention: Concurrent Control
    • Standard of Care. This will be usual care at each hemodialysis center.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of Staphylococcus aureus bloodstream infection
    • Time Frame: Through study completion (up to 3 years)
    • 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

Secondary Measures

  • Incidence of Staphylococcus aureus access related bloodstream infection (ARBSI)
    • Time Frame: Through study completion (up to 3 years)
    • 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
  • Incidence of Staphylococcus aureus local access site infection
    • Time Frame: Through study completion (up to 3 years)
    • 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
  • Incidence of Bloodstream infections by any pathogen
    • Time Frame: Through study completion (up to 3 years)
    • 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
  • Incidence of Access related bloodstream infection by any pathogen
    • Time Frame: Through study completion (up to 3 years)
    • 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
  • Incidence of Local access site infection
    • Time Frame: Through study completion (up to 3 years)
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Marin L. Schweizer, PhD
  • Collaborator
    • University of Pennsylvania
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Marin L. Schweizer, PhD, Associate Professor – University of Iowa
  • Overall Official(s)
    • Marin L Schweizer, PhD, Principal Investigator, University of Iowa
  • Overall Contact(s)
    • Marin L Schweizer, PhD, 319-338-0581, marin-schweizer@uiowa.edu

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