Candida Auris Infection, Colonization, Asymptomatic
Conditions
Keywords
Candida auris, Decolonization, Colonization, Infection Prevention, Povidone Iodine, Long-term Care
Brief summary
This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris.
Detailed 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.
Interventions
Topical intranasal povidone iodine (10%) twice daily for 5 days
Sponsors
Rush University Medical Center
RML Specialty Hospital
Mary K Hayden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of C. auris from the anterior nares | Through study completion and data analysis in three years (2028) | Culture detection of C. auris from anterior nares on intervention day 5. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of C. auris from body sites other than anterior nares | 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. |
| Detection of C. auris from environmental surfaces | 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. |
| Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares | 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. |
| Detection of MRSA from environmental surfaces | 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
| Measure | Time frame | Description |
|---|---|---|
| Non-susceptibility of C. auris to povidone iodine | 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 |
| Change in microbiome community | 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. |
Countries
United States
Contacts
Primary ContactSarah E. Sansom, DO
Backup ContactMary K. Hayden, MD
Outcome results
None listed