Impact of Nasal Antisepsis on Candida Auris Colonization
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Detection of C. auris from the anterior nares
研究概览
简要总结
This is a randomized, controlled, open-label trial of effect of 10% povidone iodine intranasal antisepsis on the detection of Candida auris.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of C. auris colonization or infection
- •Patient in a participating facility
排除标准
- •History of severe allergy to iodine-based products, defined as anaphylaxis or rash
- •Currently breastfeeding or pregnant
- •Non-English language speaking
研究组 & 干预措施
Intranasal Povidone Iodine
Nasal iodophor applied twice daily for five days.
干预措施: Povidone Iodine Topical (Drug)
结局指标
主要结局
Detection of C. auris from the anterior nares
时间窗: Through study completion and data analysis in three years (2028)
Culture detection of C. auris from anterior nares on intervention day 5.
次要结局
- Detection of methicillin-resistant Staphylococcus aureus (MRSA) from body sites other than anterior nares(Through study completion and data analysis in three years (2028))
- Detection of MRSA from environmental surfaces(Through study completion and data analysis in three years (2028))
- Detection of C. auris from body sites other than anterior nares(Through study completion and data analysis in three years (2028))
- Detection of C. auris from environmental surfaces(Through study completion and data analysis in three years (2028))
研究者
Mary K Hayden
Principal Investigator
Rush University Medical Center