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NCT Number: NCT04210505

Nasal Decolonization of Dialysis Patients Noses

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Staphylococcus Aureus Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Staphylococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory Healthcare, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Standard care

Other

Control group will receive standard care as provided by the dialysis center

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Incidence of Staphylococcus aureus bloodstream infection among patients who agreed to participate in intervention

    Time frame: Through study completion (up to 3 years)

    Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network

Sponsors and collaborators

Lead sponsor

Marin L. Schweizer, PhD

Other

Collaborators

  • 3M
  • Agency for Healthcare Research and Quality (AHRQ)
  • Emory Healthcare
  • University of Illinois at Chicago
  • University of Pennsylvania
  • Washington University School of Medicine

Registry information

Official study title

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

Acronym: PAINTS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2019
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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