Candida Auris InfectionPhase 4NCT06282510
Nasal Antisepsis for C. Auris Prevention
A Phase 4 study testing Povidone Iodine Topical in people with Candida Auris Infection and Colonization, Asymptomatic, run by Mary K Hayden at 3 sites in United States.
Trial summary
This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candida Auris Infection, Colonization, Asymptomatic
- What is being tested?
- Povidone Iodine Topical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jan 2024to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of C. auris colonization or infection
- Patient in a participating facility
Who cannot join
- History of severe allergy to iodine-based products, defined as anaphylaxis or rash
- Currently breastfeeding or pregnant
- Non-English language speaking
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Sarah E Sansom, DO, 312-563-6201, sarah_e_sansom@rush.edu
Mary K Hayden, MD, 312-942-8727, mhayden@rush.edu
- Recruiting
RML Specialty Hospital
Chicago, Illinois, 60624
Nidhi Undevia, MD, 630-286-4000, nundevia@rmlspecialtyhospital.org
Lisa Duffner, 630-286-4000, LMikolajewski@rmlspecialtyhospital.org
- Recruiting
RML Specialty Hospital
Hinsdale, Illinois, 60521
Nidhi Undevia, MD, 630-286-4000, nundevia@rmlspecialtyhospital.org
Lisa Duffner, (630) 286-4000, LMikolajewski@rmlspecialtyhospital.org
About this study
Official title: Impact of Nasal Antisepsis on Candida Auris Colonization
This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris.
Read the 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.
- Being tested
- Povidone Iodine Topical
- Keywords
- Candida auris, Decolonization, Colonization, Infection Prevention, Povidone Iodine, Long-term Care
- Medical subject headings
- Candida auris infection, Asymptomatic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone Iodine TopicalDrug
Also called Iodophor, Betadine, Profend Nasal Decolonization Kit (SKU # X12048)
Topical intranasal povidone iodine (10%) twice daily for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Intranasal Povidone Iodine | Active comparator | Nasal iodophor applied twice daily for five days. Receives: Drug: Povidone Iodine Topical |
| Control | No intervention | Routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of C. auris from the anterior nares
Culture detection of C. auris from anterior nares on intervention day 5.
Measured: Through study completion and data analysis in three years (2028)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion and data analysis in three years (2028)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start29 Jan 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candida Auris InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mary K Hayden
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center, RML Specialty Hospital
- Responsible party
- Sponsor-investigator, Mary K Hayden, Rush University Medical Center
- Investigators
- Mary K. Hayden, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282510
- Sponsor's protocol ID
- 23053003
- Status last verified
- Oct 2025
- First submitted
- 8 Feb 2024
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nasal Antisepsis on Candida Auris Colonization
- ClinicalTrials.gov ID
- NCT06282510
- Acronym / sponsor ID
- 23053003
- Keywords
- Candida auris, Decolonization, Colonization, Infection Prevention, Povidone Iodine, Long-term Care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mary K HaydenUniversity, hospital or other
- Collaborators
- Rush University Medical Center, RML Specialty Hospital
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Povidone Iodine | Active comparator | Drug: Povidone Iodine TopicalNasal iodophor applied twice daily for five days. |
| Control | No intervention | –Routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of C. auris colonization or infection
- Patient in a participating facility
Key exclusion criteria (3 listed)
- History of severe allergy to iodine-based products, defined as anaphylaxis or rash
- Currently breastfeeding or pregnant
- Non-English language speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone Iodine TopicalAlso: Iodophor, Betadine, Profend Nasal Decolonization Kit (SKU # X12048)Topical intranasal povidone iodine (10%) twice daily for 5 days | Drug | Intranasal Povidone Iodine |
Primary outcome
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.
4 secondary outcomes
Detection of C. auris from body sites other than anterior nares
Time frame: Through study completion and data analysis in three years (2028)
Detection of C. auris from environmental surfaces
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
Time frame: Through study completion and data analysis in three years (2028)
Detection of MRSA from environmental surfaces
Time frame: Through study completion and data analysis in three years (2028)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary K. Hayden, MD principal investigator
Rush University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Povidone Iodine Topical in people with Candida Auris Infection and Colonization, Asymptomatic, run by Mary K Hayden at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah E. Sansom, DO (3125636201, sarah_e_sansom@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of C. auris from the anterior nares (time frame: Through study completion and data analysis in three years (2028)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.