Nasal Antisepsis for C. Auris Prevention

Impact of Nasal Antisepsis on Candida Auris Colonization

This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris.

Study Overview

• Status: Recruiting
• Conditions: Colonization, Asymptomatic; Candida Auris Infection
• Intervention / Treatment: Drug: Povidone Iodine Topical

Detailed Description

The investigators will assess the effect of nasal antisepsis with 10% povidone iodine on nasal and skin colonization and environmental contamination with C. auris. This topical, widely used antiseptic agent is available over the counter in the U.S. It was chosen for its excellent safety profile, history as a nasal antiseptic for Staphylococcus aureus decolonization, proven in vitro activity against C. auris and feasibility in acute care and nursing home populations. This study will be conducted at 2 long-term acute care hospitals and one acute care hospital in the Chicago, IL region. Participants will first undergo intranasal screening for current C. auris colonization. Participants who grow C. auris from an anterior nares sample will be assigned 1:1 at random to receive intranasal povidone iodine (10% povidone iodine twice daily for up to 5 days) or control (no intranasal treatment). The investigators will perform all study visits during the participants' hospitalization at a participating facility. Samples will be collected on 5 days during the intervention week, then once weekly thereafter. Participants may participate for up to 8 study visits after randomization or until facility discharge, whichever occurs sooner.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sarah E. Sansom, DO; Phone Number: 3125636201; Email: sarah_e_sansom@rush.edu
• Study Contact Backup: Name: Mary K. Hayden, MD; Phone Number: 3129428727; Email: mhayden@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Sarah E Sansom, DO; Phone Number: 312-563-6201; Email: sarah_e_sansom@rush.edu
      • Contact: Mary K Hayden, MD; Phone Number: 312-942-8727; Email: mhayden@rush.edu
    • Chicago, Illinois, United States, 60624
      • Recruiting
      • RML Specialty Hospital
      • Contact: Nidhi Undevia, MD; Phone Number: 630-286-4000; Email: nundevia@rmlspecialtyhospital.org
      • Contact: Lisa Duffner; Phone Number: 630-286-4000; Email: LMikolajewski@rmlspecialtyhospital.org
    • Hinsdale, Illinois, United States, 60521
      • Recruiting
      • RML Specialty Hospital
      • Contact: Nidhi Undevia, MD; Phone Number: 630-286-4000; Email: nundevia@rmlspecialtyhospital.org
      • Contact: Lisa Duffner; Phone Number: (630) 286-4000; Email: LMikolajewski@rmlspecialtyhospital.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• History of C. auris colonization or infection
• Patient in a participating facility

Exclusion Criteria:

• History of severe allergy to iodine-based products, defined as anaphylaxis or rash
• Currently breastfeeding or pregnant
• Non-English language speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Routine care.
Active Comparator: Intranasal Povidone Iodine; Nasal iodophor applied twice daily for five days.	Drug: Povidone Iodine Topical; Topical intranasal povidone iodine (10%) twice daily for 5 days; Other Names: Betadine; Iodophor; Profend Nasal Decolonization Kit (SKU # X12048)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of C. auris from the anterior nares	Culture detection of C. auris from anterior nares on intervention day 5.	Through study completion and data analysis in three years (2028)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of C. auris from body sites other than anterior nares	Culture detection of C. auris from body sites other than anterior nares. The investigators will compare detection of C. auris by culture during intervention vs post-intervention periods.	Through study completion and data analysis in three years (2028)
Detection of C. auris from environmental surfaces	Culture detection of C. auris from participant environmental room surfaces. The investigators will compare detection of C. auris by culture during intervention vs post-intervention periods.	Through study completion and data analysis in three years (2028)
Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares	Culture detection of MRSA from body sites other than anterior nares. The investigators will compare detection of MRSA by culture during intervention vs post-intervention periods.	Through study completion and data analysis in three years (2028)
Detection of MRSA from environmental surfaces	Culture detection of MRSA from participant environmental room surfaces. The investigators will compare detection of MRSA by culture during intervention vs post-intervention periods.	Through study completion and data analysis in three years (2028)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-susceptibility of C. auris to povidone iodine	To assess for development of non-susceptibility of C. auris to povidone iodine, we will evaluate for a ≥4-fold increase in minimal inhibitory concentration (MIC) of povidone iodine pre- and post-intervention	Through study completion and data analysis in three years (2028)
Change in microbiome community	To assess for microbiome changes during the intervention, anterior nares samples will be analyzed using amplicon and/or metagenomic sequencing approaches. The investigators will compare the microbial community during intervention vs post-intervention periods.	Through study completion and data analysis in three years (2028)

Collaborators and Investigators

• Sponsor: Mary K Hayden
• Collaborators: Rush University Medical Center; RML Specialty Hospital
• Investigators: Principal Investigator: Mary K. Hayden, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Candida auris; Colonization; Povidone Iodine; Infection Prevention; Decolonization; Long-term Care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Asymptomatic Diseases; Pathological Conditions, Signs and Symptoms; Asymptomatic Infections; Candida auris infection; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Inorganic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Pyrrolidines; Plastics; Pyrrolidinones; Iodine Compounds; Polyvinyls; Vinyl Compounds; Povidone; Povidone-Iodine; Iodophors
• Other Study ID Numbers: 23053003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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