Clinical trial NCT06282510: Nasal Antisepsis for C. Auris Prevention
Official title: Impact of Nasal Antisepsis on Candida Auris Colonization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Candida Auris Infection
Colonization, Asymptomatic
Keywords: Candida auris
Decolonization
Colonization
Infection Prevention
Povidone Iodine
Long-term Care
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Rush University Medical Center
name: RML Specialty Hospital
First posted: 2024-02-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Detection of C. auris from the anterior nares
timeFrame: Through study completion and data analysis in three years (2028)
Secondary outcomes:
measure: Detection of C. auris from body sites other than anterior nares
timeFrame: Through study completion and data analysis in three years (2028)
measure: Detection of C. auris from environmental surfaces
timeFrame: Through study completion and data analysis in three years (2028)
measure: Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares
timeFrame: Through study completion and data analysis in three years (2028)
measure: Detection of MRSA from environmental surfaces
timeFrame: Through study completion and data analysis in three years (2028)
Other outcomes:
measure: Non-susceptibility of C. auris to povidone iodine
timeFrame: Through study completion and data analysis in three years (2028)
measure: Change in microbiome community
timeFrame: Through study completion and data analysis in three years (2028)
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: RML Specialty Hospital
state: Illinois
city: Hinsdale
country: United States
facility: RML Specialty Hospital
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Mary K. Hayden, MD
role: PRINCIPAL_INVESTIGATOR
References: