Nasal Antisepsis for C. Auris Prevention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Povidone Iodine Topical.
- Who it may be relevant to
- Registry conditions: Candida Auris Infection, Colonization, Asymptomatic. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Impact of Nasal Antisepsis on Candida Auris Colonization
Overview
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
- Drug Povidone Iodine Topical
Topical intranasal povidone iodine (10%) twice daily for 5 days
Primary outcome measures
- Detection of C. auris from the anterior nares [Time frame: Through study completion and data analysis in three years (2028)]
Secondary outcome measures (4)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 3 centers
- Rush University Medical Center — Chicago
- RML Specialty Hospital — Chicago
- RML Specialty Hospital — Hinsdale
Identifiers
NCT: NCT06282510 · 23053003