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| Name | Class |
|---|---|
| Rush University Medical Center | OTHER |
| RML Specialty Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Povidone Iodine | Active Comparator | Nasal iodophor applied twice daily for five days. |
|
| Control | No Intervention | Routine care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone Iodine Topical | Drug | Topical intranasal povidone iodine (10%) twice daily for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detection of C. auris from the anterior nares | Culture detection of C. auris from anterior nares on intervention day 5. | Through study completion and data analysis in three years (2028) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion and data analysis in three years (2028) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion and data analysis in three years (2028) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah E. Sansom, DO | Contact | 3125636201 | sarah_e_sansom@rush.edu | |
| Mary K. Hayden, MD | Contact | 3129428727 | mhayden@rush.edu |
| Name | Affiliation | Role |
|---|---|---|
| Mary K. Hayden, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2025 | Oct 8, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| C000656864 | Candida auris infection |
| D058345 | Asymptomatic Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D058070 | Asymptomatic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| D007466 | Iodophors |
| ID | Term |
|---|---|
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
| D014753 | Vinyl Compounds |
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| 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. |
| 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. | 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. | 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. |
| Through study completion and data analysis in three years (2028) |
| RML Specialty Hospital | Recruiting | Chicago | Illinois | 60624 | United States |
|
| RML Specialty Hospital | Recruiting | Hinsdale | Illinois | 60521 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000475 |
| Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |