Nasal Antisepsis for C. Auris Prevention

Mary K Hayden

Status and phase: Enrolling; Phase 4

Conditions: Candida Auris Infection; Colonization, Asymptomatic

Treatments: Drug: Povidone Iodine Topical

Study type: Interventional

Funder types: Other

Identifiers

NCT06282510

23053003

Details and patient eligibility

About

This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Intranasal Povidone Iodine

Active Comparator group

Description:

Nasal iodophor applied twice daily for five days.

Treatment:

Drug: Povidone Iodine Topical

Control

No Intervention group

Description:

Routine care.