Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE: A Pilot Clinical Trial

Conditions
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MRSA, VRE Infection

Intervention / Treatment
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* Other: Standard Contact Isolation
* Other: Targeted Contact Isolation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients admitted to the study ICU, the Vanderbilt University Medical Center Medical Intensive Care Unit, during an active enrollment period Exclusion Criteria: Age less than 18 years old Patients admitted during a run-in period

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Multiple-crossover, cluster-randomized, controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Contact Isolation<br>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. | Other: Standard Contact Isolation<br>* With regards to MRSA and VRE, the wearing of gowns and gloves will be required for all staff entering a patient room if the patent has an infection or colonization with MRSA or VRE or a recent history (within 90 days) of either<br>* Other names: Standard Contact Precautions;|
| Active Comparator: Targeted Contact Isolation<br>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. | Other: Targeted Contact Isolation<br>* With regards to MRSA and VRE, the wearing of gowns and gloves will be required for all staff entering a patient room if the patient has an active, highly-transmissible infection with MRSA and/or VRE. A highly-transmissible infection is defined as one with uncontained secretions or excretions (diarrhea, vomiting, or open draining wounds) or pneumonia.<br>* Other names: Targeted Contact Precautions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite rate of ICU-acquired MRSA or VRE infections | 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. | 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of ICU-acquired MRSA infection | An MRSA 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 rate will be reported in infections per 1000 patient-days. | 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment | 
| Rate of ICU-acquired VRE infection | A 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 rate will be reported in infections per 1000 patient-days. | 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment | 
| Rate of ICU-acquired MRSA bacteremia | A positive clinical blood culture for MRSA in a patient not currently diagnosed with or being treated with 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 rate will be reported in infections per 1000 patient-days. | 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment | 
| Rate of ICU-acquired VRE bacteremia | A positive clinical blood culture for VRE 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 rate will be reported in infections per 1000 patient-days. | 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 | A clinical blood culture positive for either MRSA or VRE 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. | 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 | 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 admitted to the study hospital or is within 48 hours of discharge or transfer from the study hospital, truncated at day 28 after enrollment. The composite rate will be reported in infections per 1000 patient-days. | 48 hours after enrollment to 48 hours after study hospital discharge, truncated at 28 days after enrollment | 
| Composite rate of hospital-acquired CLABSI, CAUTI, BSI, Clostridium difficile infection, and VAP. | Composite rate of certain healthcare-associated infections: central line-associated bloodstream infection (CLABSI), catheter-associated urinary tract infection (CAUTI), bloodstream infection (BSI), Clostridium difficile infection, and ventilator-associated pneumonia (VAP) in patients not currently diagnosed with or being treated for those infections, truncated at day 28 after enrollment. | 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 | All-cause mortality up until 28 days after enrollment, censored at hospital discharge | Date of enrollment until 28 days after enrollment | 
| In-hospital mortality | All-cause death while admitted to the study hospital, truncated 28 days after enrollment | Date of enrollment until hospital discharge, censored at 28 days after enrollment | 
| ICU mortality | All-cause death while admitted to the study ICU, truncated 28 days after enrollment | Date of enrollment until study ICU discharge, censored at 28 days after enrollment | 
| ICU length of stay | Length of Stay in the ICU | Study enrollment until study ICU discharge, truncated at 28 days after enrollment | 
| Hospital length of stay | Length of Stay in the Hospital | Study enrollment until study hospital discharge, truncated at 28 days after enrollment | 
| Proportion compliant with hand hygiene | Compliance by staff members with hand hygiene will be defined as using alcohol-based foam and/or soap and water immediately before entering a patient room and immediately after exiting a patient room, unless the patient specifically requires soap and water to be utilized after exiting their patient room (e.g. a patient with Clostridium difficile infection), in which case compliance after exiting that patient room would only be achieved by handwashing with soap and water. | Up to 8 months | 
| Proportion compliant with contact isolation | Compliance with contact isolation precautions by staff members will be defined as donning gown and gloves immediately prior to entering a patient room and removal of both of these items immediately before exiting a patient room. | Up to 8 months | 
| Estimated cost of gowns and gloves | This outcome will be calculated from the rate of gowns and gloves delivered to the ICU and the cost of gowns and gloves immediately prior to the start of the study. | Up to 8 months | 
| Rate of gowns delivered to ICU per patient-day | Number of gowns divided by patient ICU days | Up to 8 months | 
| Rate of gloves delivered to ICU per patient-day | Number of gloves divided by patient ICU days | Up to 8 months | 
| Adverse events (composite of falls, medication administration errors, and pressure ulcers) | Composite of falls, medication administration errors, and pressure ulcers, as defined in their respective outcomes | Study enrollment until study ICU discharge, truncated at 28 days after enrollment | 
| Falls | Documented patient fall, regardless of degree of injury sustained | Study enrollment until study ICU discharge, truncated at 28 days after enrollment | 
| Medication administration errors | Documented error in administration of medications to patients, regardless of any adverse effect on the patient | Study enrollment until study ICU discharge, truncated at 28 days after enrollment | 
| Pressure ulcers | Documented new pressure ulcer | Study enrollment until study ICU discharge, truncated at 28 days after enrollment | 
| New MRSA colonization | Patient with admission surveillance culture negative for MRSA but with discharge surveillance culture positive for MRSA (collected during the final 4 months of the study). | Study enrollment until study ICU discharge, truncated at 28 days after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient Isolation, Methicillin-Resistant Staphylococcus aureus, Vancomycin-Resistant Enterococci