Nasal Povidone-Iodine for Staph Infection

(PAINTS Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Marin L Schweizer, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Marin L. Schweizer, PhD

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marin L Schweizer, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for adult patients who are undergoing outpatient chronic hemodialysis at one of the 16 study centers. It's not for those allergic to iodine, currently battling bacterial infections, under 18, on peritoneal or home hemodialysis, or pregnant women.

Inclusion Criteria

Note: the unit of randomization is the dialysis center, not the individual patient

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

Exclusion Criteria

Patients with known sensitivity or allergy to iodine (documented or verbalized)

Patients with active bacterial infections

Children < 18 years of age.

Treatment Details

Interventions

• Povidone-Iodine Topical Ointment (Antiseptic)

Trial Overview The trial is testing if applying povidone-iodine ointment in the nose during each dialysis session can prevent Staphylococcus aureus infections. This stepped-wedge cluster randomized trial also assesses how feasible and acceptable this intervention is.

Participant Groups

Group I: Nasal Povidone-Iodine Decolonization Intervention Experimental Treatment 2 Interventions

Intranasal povidone-iodine (3M Skin and Nasal Antiseptic) will be applied to the patients' noses at each hemodialysis session.

Group II: Concurrent Control Active Control 1 Intervention

Standard of Care. This will be usual care at each hemodialysis center.

Who Is Running the Clinical Trial?

Marin L. Schweizer, PhD

Lead Sponsor

Trials

1

Recruited

300+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Laura L. Sessums

Agency for Healthcare Research and Quality (AHRQ)

Chief Medical Officer

JD, MD

Arlene S. Bierman

Agency for Healthcare Research and Quality (AHRQ)

Chief Strategy Officer

MD, MS

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

David H. Perlmutter

Washington University School of Medicine

Chief Executive Officer since 2015

MD from Washington University School of Medicine

Paul Scheel

Washington University School of Medicine

Chief Medical Officer since 2022

MD from Washington University School of Medicine

Emory Healthcare

Collaborator

Trials

6

Recruited

1,900+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Mark I. Rosenblatt

University of Illinois at Chicago

Chief Executive Officer

MD, PhD, MBA, MHA

Jon Radosta

University of Illinois at Chicago

Chief Medical Officer since 2023

MD

3M

Industry Sponsor

Trials

160

Recruited

31,600+

Dr. John Banovetz

3M

Chief Medical Officer since 2017

PhD in Inorganic Chemistry from Stanford University, Bachelor's degree in Chemistry from Hamline University

William 'Bill' Brown

3M

Chief Executive Officer

Bachelor's and Master's degrees in Mechanical Engineering from Villanova University, MBA from The Wharton School, University of Pennsylvania