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

Not Applicable

Completed

• Conditions: MRSA; VRE Infection
• Interventions: Other: Standard Contact Isolation; Other: Targeted Contact Isolation

• Registration Number: NCT03268122
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-09
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-31
• Study Start: 2017-09-01
• Primary Completion: 2018-05-30
• Study Completion: 2018-05-30
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-12
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1974

Inclusion Criteria

• All adult patients admitted to the study ICU, the Vanderbilt University Medical Center Medical Intensive Care Unit, during an active enrollment period

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Exclusion Criteria

• Age less than 18 years old
• Patients admitted during a run-in period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard Contact Isolation	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.
Targeted Contact Isolation	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.

Primary Outcome Measures

Name	Time	Method
Composite rate of ICU-acquired MRSA or VRE infections	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.

Secondary Outcome Measures

Name	Time	Method
Rate of ICU-acquired VRE bacteremia	48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment	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.
New MRSA colonization	Study enrollment until study ICU discharge, truncated at 28 days after enrollment	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).
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	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.
In-hospital mortality	Date of enrollment until hospital discharge, censored at 28 days after enrollment	All-cause death while admitted to the study hospital, truncated 28 days after enrollment
ICU length of stay	Study enrollment until study ICU discharge, truncated at 28 days after enrollment	Length of Stay in the ICU
Medication administration errors	Study enrollment until study ICU discharge, truncated at 28 days after enrollment	Documented error in administration of medications to patients, regardless of any adverse effect on the patient
Adverse events (composite of falls, medication administration errors, and pressure ulcers)	Study enrollment until study ICU discharge, truncated at 28 days after enrollment	Composite of falls, medication administration errors, and pressure ulcers, as defined in their respective outcomes
Rate of ICU-acquired MRSA infection	48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment	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.
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)	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.
28-day mortality	Date of enrollment until 28 days after enrollment	All-cause mortality up until 28 days after enrollment, censored at hospital discharge
Proportion compliant with hand hygiene	Up to 8 months	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.
Proportion compliant with contact isolation	Up to 8 months	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.
Hospital length of stay	Study enrollment until study hospital discharge, truncated at 28 days after enrollment	Length of Stay in the Hospital
Rate of gowns delivered to ICU per patient-day	Up to 8 months	Number of gowns divided by patient ICU days
Rate of gloves delivered to ICU per patient-day	Up to 8 months	Number of gloves divided by patient ICU days
Falls	Study enrollment until study ICU discharge, truncated at 28 days after enrollment	Documented patient fall, regardless of degree of injury sustained
Rate of ICU-acquired VRE infection	48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment	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.
ICU mortality	Date of enrollment until study ICU discharge, censored at 28 days after enrollment	All-cause death while admitted to the study ICU, truncated 28 days after enrollment
Estimated cost of gowns and gloves	Up to 8 months	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.
Rate of ICU-acquired MRSA bacteremia	48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment	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.
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	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.
Pressure ulcers	Study enrollment until study ICU discharge, truncated at 28 days after enrollment	Documented new pressure ulcer

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States