Cluster-randomized Non-inferiority Trial Comparing Mupirocin vs Iodophor for Nasal Decolonization of ICU Patients to Assess Impact on S. Aureus Clinical Cultures and All-cause Bloodstream Infection During Routine Chlorhexidine Bathing
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 353,323
- 试验地点
- 137
- 主要终点
- Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures
研究概览
简要总结
The Swap Out Trial is a cluster randomized controlled trial of HCA hospitals, evaluating the non-inferiority of two decolonization regimens:
Arm 1 Routine Care: ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing; Arm 2 Intervention: ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing Note: that enrolled "subjects" represents 137 individual HCA Hospitals (representing ~235 ICUs) that have been randomized.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria includes all U.S. HCA hospitals with an adult ICU;
- •Note: Unit of randomization is the hospital, but the participants are hospital adult ICUs
- •All patients within adult ICUs are included, including rare patients <18 years and >=12 years.
排除标准
- •Exclusion criteria includes ICUs with an average length of stay of less than 2 days;
- •HCA hospitals that are not able to transfer or merge data into the centralized data warehouse for the baseline and intervention periods of the study are also excluded.
研究组 & 干预措施
Arm 1: Routine Care (Mupirocin/CHG)
ICU nasal decolonization with mupirocin twice daily for 5 days in the context of chlorhexidine for daily bathing
干预措施: Arm 1. Routine Care (Mupirocin/CHG) (Drug)
Arm 2: Iodophor/CHG Decolonization
ICU nasal decolonization with iodophor twice daily for 5 days in the context of chlorhexidine for daily bathing
干预措施: Arm 2. Iodophor/CHG Decolonization (Drug)
结局指标
主要结局
Number of Participants With ICU-attributable Staphylococcus Aureus Clinical Cultures
时间窗: 18-month intervention
Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-susceptible Staphylococcus aureus (MSSA) clinical cultures attributable to participating ICUs. Defined as occurring \>2 days into a participating ICU stay through 2 days following ICU discharge. NOTE: this outcome is intended for the primary manuscript.
次要结局
- Number of Participants With ICU-attributable Bloodstream Infections(18-month intervention)
- Number of Participants With ICU Attributable MRSA Clinical Cultures(18-month intervention)
研究者
Richard Platt
Professor and Department Chair
Harvard Pilgrim Health Care