<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03268122</url>
  </required_header>
  <id_info>
    <org_study_id>161137</org_study_id>
    <nct_id>NCT03268122</nct_id>
  </id_info>
  <brief_title>Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE</brief_title>
  <acronym>CONTACT-PILOT</acronym>
  <official_title>Comparison of Standard Isolation With Targeted Isolation for Preventing Nosocomial Transmission of MRSA and VRE: A Pilot Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hospital-acquired infections are common and frequently lead to poor outcomes, including&#xD;
      death, in affected patients. Two common organisms that cause infections in the hospital are&#xD;
      methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus&#xD;
      (VRE). One strategy used to prevent these infections is contact isolation of hospitalized&#xD;
      patients with MRSA and/or VRE. It is unclear whether contact isolation decreases the rate of&#xD;
      infection with MRSA and/or VRE. The CONTACT-PILOT study is designed to test the hypothesis&#xD;
      that contact isolation decreases the rate of infection with MRSA and/or VRE in patients in&#xD;
      the intensive care unit (ICU). The study will enroll all adults in the Medical ICU and will&#xD;
      run between September 2017 and April 2018. During some months, all patients in the Medical&#xD;
      ICU patients will be placed in isolation for MRSA or VRE if they have a current infection or&#xD;
      colonization with either organism, or a recent history thereof. During other months, patients&#xD;
      will only be placed in isolation for MRSA or VRE if they have an active, highly-transmissible&#xD;
      infection with either organism, such as a pneumonia or an open, draining wound.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CONTACT-PILOT is a single center, pilot, multiple crossover, cluster-randomized trial of&#xD;
      contact isolation for MRSA and VRE in the Vanderbilt Medical Intensive Care Unit (MICU) in&#xD;
      order to determine if contact isolation reduces the rate of ICU-acquired infection with MRSA&#xD;
      and/or VRE. Specifically, the study will randomly assign the entire MICU to one of two&#xD;
      contact isolation strategies for 2 months, and then switch the entire MICU over to the second&#xD;
      strategy. The first strategy is the current practice, also referred to as standard contact&#xD;
      isolation, which is to place all patients with MRSA and/or VRE infection or colonization (or&#xD;
      a history of either) on contact isolation. The second strategy is targeted contact isolation,&#xD;
      in which patients with MRSA and/or VRE would only be placed on contact isolation if they have&#xD;
      an active infection with one (or both) of these organisms with a high risk of transmission,&#xD;
      such as an open, draining wound or a pneumonia. The study will be divided into four&#xD;
      alternating 2-month treatment blocks, two for each strategy, with one &quot;run-in&quot; week at the&#xD;
      start of each treatment block in order to transition between the two treatment strategies,&#xD;
      for a total study duration of 8 months. The interventions will occur between September 1,&#xD;
      2017 and April 30, 2018. All adult MICU patients will be enrolled in the study. The primary&#xD;
      outcome will be the rate of new ICU-acquired MRSA and VRE infections. Data analysis will be&#xD;
      performed using a pre-specified data analysis plan. This study is being performed as a&#xD;
      preliminary study to evaluate the feasibility and safety of the study plan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Multiple-crossover, cluster-randomized, controlled trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Composite rate of ICU-acquired MRSA or VRE infections</measure>
    <time_frame>48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of ICU-acquired MRSA infection</measure>
    <time_frame>48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of ICU-acquired VRE infection</measure>
    <time_frame>48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of ICU-acquired MRSA bacteremia</measure>
    <time_frame>48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of ICU-acquired VRE bacteremia</measure>
    <time_frame>48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite rate of ICU-acquired MRSA or VRE bacteremia</measure>
    <time_frame>48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite rate of hospital-acquired MRSA or VRE infection</measure>
    <time_frame>48 hours after enrollment to 48 hours after study hospital discharge, truncated at 28 days after enrollment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite rate of hospital-acquired CLABSI, CAUTI, BSI, Clostridium difficile infection, and VAP.</measure>
    <time_frame>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)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>Date of enrollment until 28 days after enrollment</time_frame>
    <description>All-cause mortality up until 28 days after enrollment, censored at hospital discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>Date of enrollment until hospital discharge, censored at 28 days after enrollment</time_frame>
    <description>All-cause death while admitted to the study hospital, truncated 28 days after enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>Date of enrollment until study ICU discharge, censored at 28 days after enrollment</time_frame>
    <description>All-cause death while admitted to the study ICU, truncated 28 days after enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>Study enrollment until study ICU discharge, truncated at 28 days after enrollment</time_frame>
    <description>Length of Stay in the ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>Study enrollment until study hospital discharge, truncated at 28 days after enrollment</time_frame>
    <description>Length of Stay in the Hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion compliant with hand hygiene</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion compliant with contact isolation</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated cost of gowns and gloves</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of gowns delivered to ICU per patient-day</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>Number of gowns divided by patient ICU days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of gloves delivered to ICU per patient-day</measure>
    <time_frame>Up to 8 months</time_frame>
    <description>Number of gloves divided by patient ICU days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events (composite of falls, medication administration errors, and pressure ulcers)</measure>
    <time_frame>Study enrollment until study ICU discharge, truncated at 28 days after enrollment</time_frame>
    <description>Composite of falls, medication administration errors, and pressure ulcers, as defined in their respective outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Falls</measure>
    <time_frame>Study enrollment until study ICU discharge, truncated at 28 days after enrollment</time_frame>
    <description>Documented patient fall, regardless of degree of injury sustained</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication administration errors</measure>
    <time_frame>Study enrollment until study ICU discharge, truncated at 28 days after enrollment</time_frame>
    <description>Documented error in administration of medications to patients, regardless of any adverse effect on the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pressure ulcers</measure>
    <time_frame>Study enrollment until study ICU discharge, truncated at 28 days after enrollment</time_frame>
    <description>Documented new pressure ulcer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New MRSA colonization</measure>
    <time_frame>Study enrollment until study ICU discharge, truncated at 28 days after enrollment</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1974</enrollment>
  <condition>MRSA</condition>
  <condition>VRE Infection</condition>
  <arm_group>
    <arm_group_label>Standard Contact Isolation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Targeted Contact Isolation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Contact Isolation</intervention_name>
    <description>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</description>
    <arm_group_label>Standard Contact Isolation</arm_group_label>
    <other_name>Standard Contact Precautions</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Targeted Contact Isolation</intervention_name>
    <description>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.&#xD;
A highly-transmissible infection is defined as one with uncontained secretions or excretions (diarrhea, vomiting, or open draining wounds) or pneumonia.</description>
    <arm_group_label>Targeted Contact Isolation</arm_group_label>
    <other_name>Targeted Contact Precautions</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients admitted to the study ICU, the Vanderbilt University Medical Center&#xD;
             Medical Intensive Care Unit, during an active enrollment period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years old&#xD;
&#xD;
          -  Patients admitted during a run-in period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd W Rice, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Huskins WC, Huckabee CM, O'Grady NP, Murray P, Kopetskie H, Zimmer L, Walker ME, Sinkowitz-Cochran RL, Jernigan JA, Samore M, Wallace D, Goldmann DA; STAR*ICU Trial Investigators. Intervention to reduce transmission of resistant bacteria in intensive care. N Engl J Med. 2011 Apr 14;364(15):1407-18. doi: 10.1056/NEJMoa1000373.</citation>
    <PMID>21488763</PMID>
  </reference>
  <reference>
    <citation>Harris AD, Pineles L, Belton B, Johnson JK, Shardell M, Loeb M, Newhouse R, Dembry L, Braun B, Perencevich EN, Hall KK, Morgan DJ; Benefits of Universal Glove and Gown (BUGG) Investigators; Shahryar SK, Price CS, Gadbaw JJ, Drees M, Kett DH, Munoz-Price LS, Jacob JT, Herwaldt LA, Sulis CA, Yokoe DS, Maragakis L, Lissauer ME, Zervos MJ, Warren DK, Carver RL, Anderson DJ, Calfee DP, Bowling JE, Safdar N. Universal glove and gown use and acquisition of antibiotic-resistant bacteria in the ICU: a randomized trial. JAMA. 2013 Oct 16;310(15):1571-80. doi: 10.1001/jama.2013.277815.</citation>
    <PMID>24097234</PMID>
  </reference>
  <reference>
    <citation>Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Avery TR, Lankiewicz J, Gombosev A, Terpstra L, Hartford F, Hayden MK, Jernigan JA, Weinstein RA, Fraser VJ, Haffenreffer K, Cui E, Kaganov RE, Lolans K, Perlin JB, Platt R; CDC Prevention Epicenters Program; AHRQ DECIDE Network and Healthcare-Associated Infections Program. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013 Jun 13;368(24):2255-65. doi: 10.1056/NEJMoa1207290. Epub 2013 May 29. Erratum In: N Engl J Med. 2013 Aug 8;369(6):587. N Engl J Med. 2014 Feb 27;370(9):886.</citation>
    <PMID>23718152</PMID>
  </reference>
  <reference>
    <citation>Morgan DJ, Murthy R, Munoz-Price LS, Barnden M, Camins BC, Johnston BL, Rubin Z, Sullivan KV, Shane AL, Dellinger EP, Rupp ME, Bearman G. Reconsidering contact precautions for endemic methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus. Infect Control Hosp Epidemiol. 2015 Oct;36(10):1163-72. doi: 10.1017/ice.2015.156. Epub 2015 Jul 3.</citation>
    <PMID>26138329</PMID>
  </reference>
  <reference>
    <citation>Derde LPG, Cooper BS, Goossens H, Malhotra-Kumar S, Willems RJL, Gniadkowski M, Hryniewicz W, Empel J, Dautzenberg MJD, Annane D, Aragao I, Chalfine A, Dumpis U, Esteves F, Giamarellou H, Muzlovic I, Nardi G, Petrikkos GL, Tomic V, Marti AT, Stammet P, Brun-Buisson C, Bonten MJM; MOSAR WP3 Study Team. Interventions to reduce colonisation and transmission of antimicrobial-resistant bacteria in intensive care units: an interrupted time series study and cluster randomised trial. Lancet Infect Dis. 2014 Jan;14(1):31-39. doi: 10.1016/S1473-3099(13)70295-0. Epub 2013 Oct 23. Erratum In: Lancet Infect Dis. 2014 Jan;14(1):11.</citation>
    <PMID>24161233</PMID>
  </reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>June 12, 2018</last_update_submitted>
  <last_update_submitted_qc>June 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Todd Rice</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Patient Isolation</keyword>
  <keyword>Methicillin-Resistant Staphylococcus aureus</keyword>
  <keyword>Vancomycin-Resistant Enterococci</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03268122
org study id: 161137
nct id: NCT03268122
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Multiple-crossover, cluster-randomized, controlled trial
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Composite rate of ICU-acquired MRSA or VRE infections
time frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
description: 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.
measure: Rate of ICU-acquired MRSA infection
time frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
description: 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.
measure: Rate of ICU-acquired VRE infection
time frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
description: 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.
measure: Rate of ICU-acquired MRSA bacteremia
time frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
description: 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.
measure: Rate of ICU-acquired VRE bacteremia
time frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
description: 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.
measure: Composite rate of ICU-acquired MRSA or VRE bacteremia
time frame: 48 hours after enrollment to 48 hours after study ICU discharge, censored at 28 days after enrollment
description: 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.
measure: Composite rate of hospital-acquired MRSA or VRE infection
time frame: 48 hours after enrollment to 48 hours after study hospital discharge, truncated at 28 days after enrollment
description: 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.
measure: Composite rate of hospital-acquired CLABSI, CAUTI, BSI, Clostridium difficile infection, and VAP.
time frame: 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)
description: 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.
measure: 28-day mortality
time frame: Date of enrollment until 28 days after enrollment
description: All-cause mortality up until 28 days after enrollment, censored at hospital discharge
measure: In-hospital mortality
time frame: Date of enrollment until hospital discharge, censored at 28 days after enrollment
description: All-cause death while admitted to the study hospital, truncated 28 days after enrollment
measure: ICU mortality
time frame: Date of enrollment until study ICU discharge, censored at 28 days after enrollment
description: All-cause death while admitted to the study ICU, truncated 28 days after enrollment
measure: ICU length of stay
time frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
description: Length of Stay in the ICU
measure: Hospital length of stay
time frame: Study enrollment until study hospital discharge, truncated at 28 days after enrollment
description: Length of Stay in the Hospital
measure: Proportion compliant with hand hygiene
time frame: Up to 8 months
description: 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.
measure: Proportion compliant with contact isolation
time frame: Up to 8 months
description: 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.
measure: Estimated cost of gowns and gloves
time frame: Up to 8 months
description: 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.
measure: Rate of gowns delivered to ICU per patient-day
time frame: Up to 8 months
description: Number of gowns divided by patient ICU days
measure: Rate of gloves delivered to ICU per patient-day
time frame: Up to 8 months
description: Number of gloves divided by patient ICU days
measure: Adverse events (composite of falls, medication administration errors, and pressure ulcers)
time frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
description: Composite of falls, medication administration errors, and pressure ulcers, as defined in their respective outcomes
measure: Falls
time frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
description: Documented patient fall, regardless of degree of injury sustained
measure: Medication administration errors
time frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
description: Documented error in administration of medications to patients, regardless of any adverse effect on the patient
measure: Pressure ulcers
time frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
description: Documented new pressure ulcer
measure: New MRSA colonization
time frame: Study enrollment until study ICU discharge, truncated at 28 days after enrollment
description: 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).
arm group label: Standard Contact Isolation
arm group type: Active Comparator
description: 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.
arm group label: Targeted Contact Isolation
arm group type: Active Comparator
description: 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.
intervention type: Other
intervention name: Standard Contact Isolation
description: 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
arm group label: Standard Contact Isolation
other name: Standard Contact Precautions
intervention type: Other
intervention name: Targeted Contact Isolation
description: 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.
arm group label: Targeted Contact Isolation
other name: Targeted Contact Precautions
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Todd W Rice, MD, MSc
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
citation: Huskins WC, Huckabee CM, O'Grady NP, Murray P, Kopetskie H, Zimmer L, Walker ME, Sinkowitz-Cochran RL, Jernigan JA, Samore M, Wallace D, Goldmann DA; STAR*ICU Trial Investigators. Intervention to reduce transmission of resistant bacteria in intensive care. N Engl J Med. 2011 Apr 14;364(15):1407-18. doi: 10.1056/NEJMoa1000373.
PMID: 21488763
citation: Harris AD, Pineles L, Belton B, Johnson JK, Shardell M, Loeb M, Newhouse R, Dembry L, Braun B, Perencevich EN, Hall KK, Morgan DJ; Benefits of Universal Glove and Gown (BUGG) Investigators; Shahryar SK, Price CS, Gadbaw JJ, Drees M, Kett DH, Munoz-Price LS, Jacob JT, Herwaldt LA, Sulis CA, Yokoe DS, Maragakis L, Lissauer ME, Zervos MJ, Warren DK, Carver RL, Anderson DJ, Calfee DP, Bowling JE, Safdar N. Universal glove and gown use and acquisition of antibiotic-resistant bacteria in the ICU: a randomized trial. JAMA. 2013 Oct 16;310(15):1571-80. doi: 10.1001/jama.2013.277815.
PMID: 24097234
citation: Huang SS, Septimus E, Kleinman K, Moody J, Hickok J, Avery TR, Lankiewicz J, Gombosev A, Terpstra L, Hartford F, Hayden MK, Jernigan JA, Weinstein RA, Fraser VJ, Haffenreffer K, Cui E, Kaganov RE, Lolans K, Perlin JB, Platt R; CDC Prevention Epicenters Program; AHRQ DECIDE Network and Healthcare-Associated Infections Program. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 2013 Jun 13;368(24):2255-65. doi: 10.1056/NEJMoa1207290. Epub 2013 May 29. Erratum In: N Engl J Med. 2013 Aug 8;369(6):587. N Engl J Med. 2014 Feb 27;370(9):886.
PMID: 23718152
citation: Morgan DJ, Murthy R, Munoz-Price LS, Barnden M, Camins BC, Johnston BL, Rubin Z, Sullivan KV, Shane AL, Dellinger EP, Rupp ME, Bearman G. Reconsidering contact precautions for endemic methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus. Infect Control Hosp Epidemiol. 2015 Oct;36(10):1163-72. doi: 10.1017/ice.2015.156. Epub 2015 Jul 3.
PMID: 26138329
citation: Derde LPG, Cooper BS, Goossens H, Malhotra-Kumar S, Willems RJL, Gniadkowski M, Hryniewicz W, Empel J, Dautzenberg MJD, Annane D, Aragao I, Chalfine A, Dumpis U, Esteves F, Giamarellou H, Muzlovic I, Nardi G, Petrikkos GL, Tomic V, Marti AT, Stammet P, Brun-Buisson C, Bonten MJM; MOSAR WP3 Study Team. Interventions to reduce colonisation and transmission of antimicrobial-resistant bacteria in intensive care units: an interrupted time series study and cluster randomised trial. Lancet Infect Dis. 2014 Jan;14(1):31-39. doi: 10.1016/S1473-3099(13)70295-0. Epub 2013 Oct 23. Erratum In: Lancet Infect Dis. 2014 Jan;14(1):11.
PMID: 24161233
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Todd Rice
investigator title: Associate Professor of Medicine