A Phase 4 interventional study of Povidone Iodine Topical in Candida Auris Infection and Colonization, Asymptomatic, sponsored by Mary K Hayden. Recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-15.
Sponsored by Mary K Hayden · Phase 4, Interventional, and Prevention
This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris.
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.
27 studies on the registry are indexed under Asymptomatic Infections; 7 are open to participants now.
This study's planned enrollment of 120 is above the median of 55 across 16 interventional studies indexed under Asymptomatic Infections.
Browse Asymptomatic Infections studies →This is the only study on the registry with Mary K Hayden as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Nasal iodophor applied twice daily for five days.
Drug: Povidone Iodine Topical
Routine care.
Topical intranasal povidone iodine (10%) twice daily for 5 days
Also known as: Iodophor, Betadine, Profend Nasal Decolonization Kit (SKU # X12048)
Detection of C. auris from the anterior nares
Culture detection of C. auris from anterior nares on intervention day 5.
Time frame: Through study completion and data analysis in three years (2028)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion and data analysis in three years (2028)
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
Time frame: 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.
Time frame: Through study completion and data analysis in three years (2028)
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Plan to share: No
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Candida auris infection