Nasal Antisepsis for C. Auris Prevention

Last updated: February 26, 2025
Sponsor: Mary K Hayden
Overall Status: Active - Recruiting

Phase

4

Condition

Candidemia/candidiasis

Treatment

Povidone Iodine Topical

Clinical Study ID

NCT06282510
23053003
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of C. auris colonization or infection

  • Patient in a participating facility

Exclusion

Exclusion Criteria:

  • History of severe allergy to iodine-based products, defined as anaphylaxis or rash

  • Currently breastfeeding or pregnant

  • Non-English language speaking

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: Povidone Iodine Topical
Phase: 4
Study Start date:
January 29, 2024
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • RML Specialty Hospital

    Chicago, Illinois 60624
    United States

    Active - Recruiting

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Active - Recruiting

  • RML Specialty Hospital

    Hinsdale, Illinois 60521
    United States

    Active - Recruiting

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