<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/NCT01671358</url>
  </required_header>
  <id_info>
    <org_study_id>WVU-00010</org_study_id>
    <nct_id>NCT01671358</nct_id>
  </id_info>
  <brief_title>Comparison of Bacterial Contamination Rates Between Isolation and Non-isolation Rooms</brief_title>
  <official_title>Comparison of Contamination Rates of Medication Storage Cabinets Between Isolation and Non-isolation Rooms With Methicillin-resistant Staphylococcus Aureus (MRSA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to determine if medication cabinets located outside of isolation rooms in&#xD;
      hospitals and their contents, particularly medications and the delivery folders are at a&#xD;
      higher risk of having harmful bacteria on them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies show high touch areas maybe contaminated with organisms such as Methicillin-resistant&#xD;
      Staphylococcus aureus(MRSA) and vancomycin-resistant enterococci. MRSA can live on hospital&#xD;
      surfaces for 9-14 days. Patients in rooms that were previously MRSA isolation rooms are at&#xD;
      higher risk for developing a hospital-acquired infection.&#xD;
&#xD;
      This study is to determine if medication cabinets located outside of MRSA isolation rooms and&#xD;
      their contents, particularly medications and the pharmacy delivery folders are at a higher&#xD;
      risk of having MRSA colonization on them. This study will use conventional methods to&#xD;
      determine if MRSA colonization is present and compare results between non-isolation and&#xD;
      isolation rooms. This will evaluate if alternate measures for the reduction of MRSA&#xD;
      colonization are needed for the MRSA isolation rooms in regards to medication delivery and&#xD;
      storage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of MRSA colonization</measure>
    <time_frame>Hospital stay, an expected average of 14 days</time_frame>
    <description>Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. Individual colonies will be removed from the plate with an inoculation loop, then streaked onto a second sheep blood agar plate. The second plates will be incubated for 48 hours. The colonies will then be run through standard identification tests to determine if the colonies are MRSA or not. A comparison will be made between non-isolation and isolation rooms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantification of MRSA colonization</measure>
    <time_frame>Hospital stay, an expected average of 14 days</time_frame>
    <description>Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. A comparison between the sites of swabbing will be performed.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Presence of other bacterial colonization</measure>
    <time_frame>Hospital stay, an expected average of 14 days</time_frame>
    <description>Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. Individual colonies will be removed from the plate with an inoculation loop, then streaked onto a second sheep blood agar plate. The second plates will be incubated for 48 hours. The colonies will be categorized as gram negative, gram positive catalase negative, Gram positive coagulase negative Staphylococcus species or methicillin-sensitive Staphylococcus aureus. This will serve as a baseline epidemiology of the hospital and generate other possible hypotheses.</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between MRSA and active infection or colonization of patient</measure>
    <time_frame>Hospital stay, an expected average of 14 days</time_frame>
    <description>The patient from the same time frame in the rooms sampled and positive for MRSA colonization will be reviewed to determine if they had active infection or were previously colonized.</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between colonization of other positive organisms and active infection or colonization of patient</measure>
    <time_frame>Hospital stay, an expected average of 14 days</time_frame>
    <description>The patient from the same time frame in the rooms sampled and positive for non-MRSA colonization will be reviewed to determine if they had active infection or were previously colonized.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Methicillin-Resistant Staphylococcus Aureus</condition>
  <arm_group>
    <arm_group_label>Isolation Rooms for MRSA</arm_group_label>
    <description>Rooms that currently have a patient in them that are in isolation status due to MRSA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-isolation rooms</arm_group_label>
    <description>Rooms that have not been occupied by a patient in isolation due to MRSA for 14 days</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Inaptients at an academic medical center&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient rooms with isolation status for MRSA&#xD;
&#xD;
          -  Patient rooms without isolation status for MRSA for 14 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Rooms without medication cabinets directly outside the room&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>West Virginia University Hospitals</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bures S, Fishbain JT, Uyehara CF, Parker JM, Berg BW. Computer keyboards and faucet handles as reservoirs of nosocomial pathogens in the intensive care unit. Am J Infect Control. 2000 Dec;28(6):465-71. doi: 10.1067/mic.2000.107267.</citation>
    <PMID>11114617</PMID>
  </reference>
  <reference>
    <citation>Sexton T, Clarke P, O'Neill E, Dillane T, Humphreys H. Environmental reservoirs of methicillin-resistant Staphylococcus aureus in isolation rooms: correlation with patient isolates and implications for hospital hygiene. J Hosp Infect. 2006 Feb;62(2):187-94. doi: 10.1016/j.jhin.2005.07.017. Epub 2005 Nov 14.</citation>
    <PMID>16290319</PMID>
  </reference>
  <reference>
    <citation>Oie S, Hosokawa I, Kamiya A. Contamination of room door handles by methicillin-sensitive/methicillin-resistant Staphylococcus aureus. J Hosp Infect. 2002 Jun;51(2):140-3. doi: 10.1053/jhin.2002.1221.</citation>
    <PMID>12090803</PMID>
  </reference>
  <reference>
    <citation>Huang SS, Datta R, Platt R. Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch Intern Med. 2006 Oct 9;166(18):1945-51. doi: 10.1001/archinte.166.18.1945.</citation>
    <PMID>17030826</PMID>
  </reference>
  <reference>
    <citation>Huang R, Mehta S, Weed D, Price CS. Methicillin-resistant Staphylococcus aureus survival on hospital fomites. Infect Control Hosp Epidemiol. 2006 Nov;27(11):1267-9. doi: 10.1086/507965. Epub 2006 Sep 28.</citation>
    <PMID>17080391</PMID>
  </reference>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>June 1, 2015</last_update_submitted>
  <last_update_submitted_qc>June 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Virginia University</investigator_affiliation>
    <investigator_full_name>Michael Sweet</investigator_full_name>
    <investigator_title>Pharmacy Clinical Specialist - Quality Outcomes</investigator_title>
  </responsible_party>
  <keyword>MRSA</keyword>
  <keyword>Contamination</keyword>
  <keyword>Isolation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Staphylococcal Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT01671358
org study id: WVU-00010
nct id: NCT01671358
lead sponsor: 
has dmc: No
This study is to determine if medication cabinets located outside of isolation rooms in
      hospitals and their contents, particularly medications and the delivery folders are at a
      higher risk of having harmful bacteria on them.
Studies show high touch areas maybe contaminated with organisms such as Methicillin-resistant
      Staphylococcus aureus(MRSA) and vancomycin-resistant enterococci. MRSA can live on hospital
      surfaces for 9-14 days. Patients in rooms that were previously MRSA isolation rooms are at
      higher risk for developing a hospital-acquired infection.

      This study is to determine if medication cabinets located outside of MRSA isolation rooms and
      their contents, particularly medications and the pharmacy delivery folders are at a higher
      risk of having MRSA colonization on them. This study will use conventional methods to
      determine if MRSA colonization is present and compare results between non-isolation and
      isolation rooms. This will evaluate if alternate measures for the reduction of MRSA
      colonization are needed for the MRSA isolation rooms in regards to medication delivery and
      storage.
observational model: Cohort
time perspective: Prospective
measure: Presence of MRSA colonization
time frame: Hospital stay, an expected average of 14 days
description: Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. Individual colonies will be removed from the plate with an inoculation loop, then streaked onto a second sheep blood agar plate. The second plates will be incubated for 48 hours. The colonies will then be run through standard identification tests to determine if the colonies are MRSA or not. A comparison will be made between non-isolation and isolation rooms.
measure: Quantification of MRSA colonization
time frame: Hospital stay, an expected average of 14 days
description: Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. A comparison between the sites of swabbing will be performed.
measure: Presence of other bacterial colonization
time frame: Hospital stay, an expected average of 14 days
description: Swabbing of four areas of the medication cabinet will be performed (keypad, handle, medication folder and a medication). A Semi-quantitative sampling technique will be used to collect the samples. A sterile saline moistened sterile cotton tip swab will be used to swab the specified areas. The swabs will then be used to inoculate sheep blood agar plates in 4 quadrants. The plates will be incubated for 48 hours. The number of quadrants with growth will be identified. Individual colonies will be removed from the plate with an inoculation loop, then streaked onto a second sheep blood agar plate. The second plates will be incubated for 48 hours. The colonies will be categorized as gram negative, gram positive catalase negative, Gram positive coagulase negative Staphylococcus species or methicillin-sensitive Staphylococcus aureus. This will serve as a baseline epidemiology of the hospital and generate other possible hypotheses.
measure: Correlation between MRSA and active infection or colonization of patient
time frame: Hospital stay, an expected average of 14 days
description: The patient from the same time frame in the rooms sampled and positive for MRSA colonization will be reviewed to determine if they had active infection or were previously colonized.
measure: Correlation between colonization of other positive organisms and active infection or colonization of patient
time frame: Hospital stay, an expected average of 14 days
description: The patient from the same time frame in the rooms sampled and positive for non-MRSA colonization will be reviewed to determine if they had active infection or were previously colonized.
arm group label: Isolation Rooms for MRSA
description: Rooms that currently have a patient in them that are in isolation status due to MRSA
arm group label: Non-isolation rooms
description: Rooms that have not been occupied by a patient in isolation due to MRSA for 14 days
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Bures S, Fishbain JT, Uyehara CF, Parker JM, Berg BW. Computer keyboards and faucet handles as reservoirs of nosocomial pathogens in the intensive care unit. Am J Infect Control. 2000 Dec;28(6):465-71. doi: 10.1067/mic.2000.107267.
PMID: 11114617
citation: Sexton T, Clarke P, O'Neill E, Dillane T, Humphreys H. Environmental reservoirs of methicillin-resistant Staphylococcus aureus in isolation rooms: correlation with patient isolates and implications for hospital hygiene. J Hosp Infect. 2006 Feb;62(2):187-94. doi: 10.1016/j.jhin.2005.07.017. Epub 2005 Nov 14.
PMID: 16290319
citation: Oie S, Hosokawa I, Kamiya A. Contamination of room door handles by methicillin-sensitive/methicillin-resistant Staphylococcus aureus. J Hosp Infect. 2002 Jun;51(2):140-3. doi: 10.1053/jhin.2002.1221.
PMID: 12090803
citation: Huang SS, Datta R, Platt R. Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch Intern Med. 2006 Oct 9;166(18):1945-51. doi: 10.1001/archinte.166.18.1945.
PMID: 17030826
citation: Huang R, Mehta S, Weed D, Price CS. Methicillin-resistant Staphylococcus aureus survival on hospital fomites. Infect Control Hosp Epidemiol. 2006 Nov;27(11):1267-9. doi: 10.1086/507965. Epub 2006 Sep 28.
PMID: 17080391
responsible party type: Principal Investigator
investigator affiliation: West Virginia University
investigator full name: Michael Sweet
investigator title: Pharmacy Clinical Specialist - Quality Outcomes
mesh term: Staphylococcal Infections