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NCT Number: NCT06282510

Nasal Antisepsis for C. Auris Prevention

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

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Key information

Conditions

Candida Auris Infection Asymptomatic Diseases Asymptomatic Infections Colonization, Asymptomatic Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

RML Specialty Hospital, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Povidone Iodine Topical

Drug

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

Other names: Iodophor, Betadine, Profend Nasal Decolonization Kit (SKU # X12048)

Primary outcomes

  1. Detection of C. auris from the anterior nares

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

    Culture detection of C. auris from anterior nares on intervention day 5.

Secondary outcomes

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

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

    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.

  2. Detection of C. auris from environmental surfaces

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

    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.

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

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

    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.

  4. Detection of MRSA from environmental surfaces

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

    Culture detection of MRSA from participant environmental room surfaces. The investigators will compare detection of MRSA by culture during intervention vs post-intervention periods.

Other outcomes

  1. Non-susceptibility of C. auris to povidone iodine

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

    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

  2. Change in microbiome community

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary K. Hayden, MD

CONTACT

[email protected]

3129428727

Sarah E. Sansom, DO

CONTACT

[email protected]

3125636201

Sponsors and collaborators

Lead sponsor

Mary K Hayden

Other

Collaborators

  • RML Specialty Hospital
  • Rush University Medical Center

Registry information

Official study title

Impact of Nasal Antisepsis on Candida Auris Colonization

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Feb 28, 2024
Registry last updated
Oct 15, 2025

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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