Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE: A Pilot Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,974
- 试验地点
- 2
- 主要终点
- Composite rate of ICU-acquired MRSA or VRE infections
研究概览
简要总结
Hospital-acquired infections are common and frequently lead to poor outcomes, including death, in affected patients. Two common organisms that cause infections in the hospital are methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE). One strategy used to prevent these infections is contact isolation of hospitalized patients with MRSA and/or VRE. It is unclear whether contact isolation decreases the rate of infection with MRSA and/or VRE. The CONTACT-PILOT study is designed to test the hypothesis that contact isolation decreases the rate of infection with MRSA and/or VRE in patients in the intensive care unit (ICU). The study will enroll all adults in the Medical ICU and will run between September 2017 and April 2018. During some months, all patients in the Medical ICU patients will be placed in isolation for MRSA or VRE if they have a current infection or colonization with either organism, or a recent history thereof. During other months, patients will only be placed in isolation for MRSA or VRE if they have an active, highly-transmissible infection with either organism, such as a pneumonia or an open, draining wound.
详细描述
CONTACT-PILOT is a single center, pilot, multiple crossover, cluster-randomized trial of contact isolation for MRSA and VRE in the Vanderbilt Medical Intensive Care Unit (MICU) in order to determine if contact isolation reduces the rate of ICU-acquired infection with MRSA and/or VRE. Specifically, the study will randomly assign the entire MICU to one of two contact isolation strategies for 2 months, and then switch the entire MICU over to the second strategy. The first strategy is the current practice, also referred to as standard contact isolation, which is to place all patients with MRSA and/or VRE infection or colonization (or a history of either) on contact isolation. The second strategy is targeted contact isolation, in which patients with MRSA and/or VRE would only be placed on contact isolation if they have an active infection with one (or both) of these organisms with a high risk of transmission, such as an open, draining wound or a pneumonia. The study will be divided into four alternating 2-month treatment blocks, two for each strategy, with one "run-in" week at the start of each treatment block in order to transition between the two treatment strategies, for a total study duration of 8 months. The interventions will occur between September 1, 2017 and April 30, 2018. All adult MICU patients will be enrolled in the study. The primary outcome will be the rate of new ICU-acquired MRSA and VRE infections. Data analysis will be performed using a pre-specified data analysis plan. This study is being performed as a preliminary study to evaluate the feasibility and safety of the study plan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •All adult patients admitted to the study ICU, the Vanderbilt University Medical Center Medical Intensive Care Unit, during an active enrollment period
排除标准
- •Age less than 18 years old
- •Patients admitted during a run-in period
研究组 & 干预措施
Standard Contact Isolation
Patients in the standard contact isolation arm will be under the standard contact isolation strategy during the entire time they are physically located in the Medical ICU.
干预措施: Standard Contact Isolation (Other)
Targeted Contact Isolation
Patients in the targeted contact isolation arm will be under the targeted contact isolation strategy during the entire time they are physically located in the Medical ICU.
干预措施: Targeted Contact Isolation (Other)
结局指标
主要结局
Composite rate of ICU-acquired MRSA or VRE infections
时间窗: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
The primary endpoint is defined as an MRSA or VRE infection in a patient not currently diagnosed with or being treated for that infection at least 48 hours after admission to the study ICU and while the patient either remains in the study ICU or is within 48 hours of discharge or transfer from the study ICU, truncated at day 28 after enrollment. The composite rate will be reported in infections per 1000 patient-days.
次要结局
- Rate of ICU-acquired VRE bacteremia(48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment)
- Composite rate of hospital-acquired MRSA or VRE infection(48 hours after enrollment to 48 hours after study hospital discharge, truncated at 28 days after enrollment)
- In-hospital mortality(Date of enrollment until hospital discharge, censored at 28 days after enrollment)
- ICU length of stay(Study enrollment until study ICU discharge, truncated at 28 days after enrollment)
- Medication administration errors(Study enrollment until study ICU discharge, truncated at 28 days after enrollment)
- Hospital length of stay(Study enrollment until study hospital discharge, truncated at 28 days after enrollment)
- Rate of ICU-acquired MRSA infection(48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment)
- Composite rate of hospital-acquired CLABSI, CAUTI, BSI, Clostridium difficile infection, and VAP.(48 hours after enrollment to 48 hours after study ICU discharge, truncated at day 28 after enrollment (except for Clostridium difficile infections, which are truncated at the time of study ICU discharge))
- 28-day mortality(Date of enrollment until 28 days after enrollment)
- Proportion compliant with hand hygiene(Up to 8 months)
- Proportion compliant with contact isolation(Up to 8 months)
- Rate of gowns delivered to ICU per patient-day(Up to 8 months)
- Rate of gloves delivered to ICU per patient-day(Up to 8 months)
- Falls(Study enrollment until study ICU discharge, truncated at 28 days after enrollment)
- Rate of ICU-acquired VRE infection(48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment)
- ICU mortality(Date of enrollment until study ICU discharge, censored at 28 days after enrollment)
- Estimated cost of gowns and gloves(Up to 8 months)
- New MRSA colonization(Study enrollment until study ICU discharge, truncated at 28 days after enrollment)
- Pressure ulcers(Study enrollment until study ICU discharge, truncated at 28 days after enrollment)
- Rate of ICU-acquired MRSA bacteremia(48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment)
- Composite rate of ICU-acquired MRSA or VRE bacteremia(48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment)
- Adverse events (composite of falls, medication administration errors, and pressure ulcers)(Study enrollment until study ICU discharge, truncated at 28 days after enrollment)
研究者
Todd Rice
Associate Professor of Medicine
Vanderbilt University Medical Center