NCT06282510

Nasal Antisepsis for C. Auris Prevention

Impact of Nasal Antisepsis on Candida Auris Colonization

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Mary K Hayden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Candida Auris Infection
• Colonization, Asymptomatic

Interventions

Type	Name	Description
DRUG	Povidone Iodine Topical	Topical intranasal povidone iodine (10%) twice daily for 5 days

Timeline

• Start date: 2024-01-29
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2024-02-28
• Last updated: 2025-10-15

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study