Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06282510
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-08
Brief Title:
Nasal Antisepsis for C Auris Prevention
Sponsor:
Mary K Hayden
Organization:
Rush University Medical Center
Study Overview
Official Title:
Impact of Nasal Antisepsis on Candida Auris Colonization
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None