Nasal Antisepsis for C. Auris Prevention

NCT ID: NCT06282510

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2028-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Candida Auris Infection Colonization, Asymptomatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intranasal Povidone Iodine

Nasal iodophor applied twice daily for five days.

Group Type ACTIVE_COMPARATOR

Povidone Iodine Topical

Intervention Type DRUG

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

Control

Routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Povidone Iodine Topical

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

Intervention Type DRUG

Other Intervention Names

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Iodophor Betadine Profend Nasal Decolonization Kit (SKU # X12048)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role collaborator

RML Specialty Hospital

OTHER

Sponsor Role collaborator

Mary K Hayden

OTHER

Sponsor Role lead

Responsible Party

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Mary K Hayden

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Mary K. Hayden, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

RML Specialty Hospital

Chicago, Illinois, United States

Site Status RECRUITING

RML Specialty Hospital

Hinsdale, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah E. Sansom, DO

Role: CONTACT

3125636201

Mary K. Hayden, MD

Role: CONTACT

3129428727

Facility Contacts

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Sarah E Sansom, DO

Role: primary

312-563-6201

Mary K Hayden, MD

Role: backup

312-942-8727

Nidhi Undevia, MD

Role: primary

630-286-4000

Lisa Duffner

Role: backup

630-286-4000

Nidhi Undevia, MD

Role: primary

630-286-4000

Lisa Duffner

Role: backup

(630) 286-4000

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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23053003

Identifier Type: -

Identifier Source: org_study_id

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