NCT06282510

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
31mo left

Started Jan 2024

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Jan 2024Dec 2028

Study Start

First participant enrolled

January 29, 2024

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 15, 2025

Status Verified

October 1, 2025

Enrollment Period

2.8 years

First QC Date

February 8, 2024

Last Update Submit

October 13, 2025

Conditions

Candida Auris InfectionColonization, Asymptomatic

Keywords

Candida aurisDecolonizationColonizationInfection PreventionPovidone IodineLong-term Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Detection of C. auris from body sites other than anterior nares

    Through study completion and data analysis in three years (2028)

  • Detection of C. auris from environmental surfaces

    Through study completion and data analysis in three years (2028)

  • Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares

    Through study completion and data analysis in three years (2028)

  • Detection of MRSA from environmental surfaces

    Through study completion and data analysis in three years (2028)

Other Outcomes (2)

  • Non-susceptibility of C. auris to povidone iodine

    Through study completion and data analysis in three years (2028)

  • Change in microbiome community

    Through study completion and data analysis in three years (2028)

Study Arms (2)

Intranasal Povidone Iodine

ACTIVE COMPARATOR

Nasal iodophor applied twice daily for five days.

Drug: Povidone Iodine Topical

Control

NO INTERVENTION

Routine care.

Interventions

Povidone Iodine TopicalDRUG

Topical intranasal povidone iodine (10%) twice daily for 5 days

Also known as: Iodophor, Betadine, Profend Nasal Decolonization Kit (SKU # X12048)
Intranasal Povidone Iodine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

RML Specialty Hospital

Chicago, Illinois, 60624, United States

RECRUITING

RML Specialty Hospital

Hinsdale, Illinois, 60521, United States

RECRUITING

MeSH Terms

Conditions

Candida auris infectionAsymptomatic Infections

Interventions

Povidone-IodineIodophors

Condition Hierarchy (Ancestors)

InfectionsAsymptomatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodine CompoundsInorganic ChemicalsPolyvinylsVinyl CompoundsAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsPovidonePyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPlasticsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Mary K. Hayden, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah E. Sansom, DO

CONTACT

3125636201sarah_e_sansom@rush.edu

Mary K. Hayden, MD

CONTACT

3129428727mhayden@rush.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2024

First Posted

February 28, 2024

Study Start

January 29, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Last Updated

October 15, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(3)