<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/NCT03802461</url>
  </required_header>
  <id_info>
    <org_study_id>18-5177</org_study_id>
    <nct_id>NCT03802461</nct_id>
  </id_info>
  <brief_title>Effectiveness of Fecal Flora Alteration for Eradication of Carbapenemase-producing Enterobacteriaceae Colonization</brief_title>
  <acronym>EFFECT-CPE</acronym>
  <official_title>Effectiveness of Fecal Flora Alteration for Eradication of Carbapenemase-producing Enterobacteriaceae Colonization Trial (EFFECT-CPE): a Multisite, Open-label, Randomized Controlled Feasibility Pilot Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Susy Hota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sinai Health System, Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Toronto, Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Toronto Invasive Bacterial Diseases Network, Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Public Health Ontario Laboratories, Ontario, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Carbapenemase-producing Enterobacteriaceae (CPE) are bacteria carried in the gastrointestinal&#xD;
      tract that are resistant to carbapenems, antibiotics of last resort. CPE infections result in&#xD;
      death in 25-50% of cases. Fecal microbiota transplantation (FMT) is the transfer of stool&#xD;
      from a healthy donor to a recipient to alter the composition of gut microbes. Early studies&#xD;
      support its use for eliminating CPE carriage but definitive studies are lacking. The&#xD;
      investigators propose a feasibility pilot for a multicenter, non-blinded randomized trial&#xD;
      comparing the effectiveness of FMT with no intervention (standard of care) in eliminating&#xD;
      intestinal carriage of CPE. Forty patients with CPE will be randomly assigned to receive FMT&#xD;
      by enema or no intervention. Feasibility will be demonstrated by the ability to recruit and&#xD;
      retain 40 patients over 12 months, and to provide FMT made at a central site to at least one&#xD;
      off-site hospital. The primary clinical endpoint for the full trial is CPE intestinal&#xD;
      carriage 3 months after the intervention. Secondary endpoints include: CPE carriage at 1, 6&#xD;
      and 12 months; time to decolonization of CPE; safety; CPE infections over 12 months; and,&#xD;
      intestinal carriage of other antibiotic-resistant organisms. Data on the clinical outcomes&#xD;
      will be collected but not analyzed in this feasibility study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multisite, open-label randomized controlled internal pilot trial designed to assess&#xD;
      the feasibility of a larger trial aimed at determining the effectiveness of fecal microbiota&#xD;
      transplantation (FMT) by enema in short and long term intestinal decolonization of&#xD;
      carbapenemase-producing Enterobacteriaceae (CPE). Forty (40) asymptomatic adult patients&#xD;
      intestinally colonized with CPE will be allocated in a 1:1 ratio to receive a bowel&#xD;
      preparation followed by FMT by enema route, versus standard of care (no intervention). FMT&#xD;
      will be provided by the University of Toronto Microbiota Therapeutics Outcomes Program&#xD;
      (MTOP), using standardized operating procedures for recruiting and screening FMT donors,&#xD;
      manufacturing FMT and administering FMT by enema. The feasibility outcomes are: successful&#xD;
      randomization of 40 patients within 12 months, retention of &gt;90% (36/40) of patients up to 6&#xD;
      months, and provision of FMT at a non-primary study site in at least one patient. Data on the&#xD;
      clinical and exploratory outcomes will be collected but not analyzed in this pilot study. The&#xD;
      primary clinical outcome is incidence of intestinal decolonization of CPE at 3 months.&#xD;
      Secondary clinical outcomes include: time to decolonization of CPE; incidence of CPE clinical&#xD;
      infections up to 12 months post-intervention; incidence of intestinal decolonization of CPE&#xD;
      and other antibiotic-resistant organisms (extended spectrum beta-lactamase Enterobacteriaceae&#xD;
      - ESBLs and vancomycin-resistant Enterococci - VRE) at 1, 3, 6 and 12 months&#xD;
      post-intervention; and, safety profile. As an exploratory outcome, changes in fecal&#xD;
      microbiome composition will be examined before and after intervention. This study leverages&#xD;
      existing support, research infrastructures and expertise - including the Toronto Invasive&#xD;
      Bacterial Diseases Network (TIBDN), Toronto Antimicrobial Resistance Research Network&#xD;
      (TARRN), and the University of Toronto Microbiota Therapeutics Outcomes Program (MTOP) - to&#xD;
      optimize feasibility regarding patient recruitment and FMT administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Temporarily on hold due to COVID-19 pandemic&#xD;
  </why_stopped>
  <start_date type="Actual">March 22, 2019</start_date>
  <completion_date type="Anticipated">March 20, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 15, 2023</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Asymptomatic adult patients intestinally colonized with CPE will either randomized to receive fecal microbiota transplantation (intervention) or standard of care (no intervention).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of intestinal colonization of patients with CPE 3 months after intervention.</measure>
    <time_frame>3 months</time_frame>
    <description>Incidence of CPE colonization in FMT arm vs control arm at 3 months</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Randomization rate in study</measure>
    <time_frame>12 months</time_frame>
    <description>Completion of randomization of 40 study participants during the study period will be used to indicate feasibility of the study.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of patients retained in study for up to 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>A retention of 90% of patients up to 6 months in the study will be used to indicate feasibility.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of CPE decolonization in FMT-treatment and non-treatment groups at 1, 6 and 12 months.</measure>
    <time_frame>1, 6, and 12 months</time_frame>
    <description>As above</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to CPE decolonization in FMT-treatment and non-treatment groups.</measure>
    <time_frame>1, 3, 6, and 12 months</time_frame>
    <description>As above</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of CPE clinical infection in FMT treatment and non-treatment groups over 12 months.</measure>
    <time_frame>1, 3, 6, and 12 months</time_frame>
    <description>As above</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of extended spectrum beta-lactamase organisms (ESBL) and vancomycin-resistant Enterococci (VRE) intestinal colonization at 0, 1, 3, 6 and 12 months in FMT treatment and non-treatment groups.</measure>
    <time_frame>1, 3, 6, and 12 months</time_frame>
    <description>Changes in colonization status of other antimicrobial resistant organisms over the study period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of solicited and unsolicited adverse and serious adverse events in both groups</measure>
    <time_frame>3 months</time_frame>
    <description>Participants will be asked to report adverse and serious adverse events will be throughout the study period and will be asked specifically about adverse events during study visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with all-cause mortality at 30 days post-randomization</measure>
    <time_frame>1 month</time_frame>
    <description>As above</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Changes in composition and diversity of fecal bacterial phyla (as measured by 16s ribosomal ribonucleic acid sequencing) in both intervention groups</measure>
    <time_frame>12 months</time_frame>
    <description>As above</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>Fecal Microbiota Transplantation (FMT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bowel lavage preparation followed by FMT administered by enema, given on 3 occasions. Fecal filtrate for FMT will be prepared from 50 g of healthy donor stool, homogenized, and diluted in 300 mL sterile normal saline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this arm will not receive intervention and will be on standard of care .</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fecal Microbiota Transplantation (FMT)</intervention_name>
    <description>Feces from healthy donor</description>
    <arm_group_label>Fecal Microbiota Transplantation (FMT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18 years&#xD;
&#xD;
          2. ≥ 1 rectal swab, groin, stool, or urine specimen positive for a CPE within the past 1&#xD;
             month.&#xD;
&#xD;
             • Presence of CPE will be confirmed at baseline through collection of pooled&#xD;
             groin/rectal swab and urine specimen.&#xD;
&#xD;
          3. Women of childbearing age must be using at least one reliable form of birth control.&#xD;
&#xD;
          4. Must be able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active infection with CPE at the time of assessment.&#xD;
&#xD;
          2. Pregnancy, planned pregnancy or breastfeeding.&#xD;
&#xD;
          3. Current admission to intensive care unit.&#xD;
&#xD;
          4. Significantly immunocompromised patients .&#xD;
&#xD;
               -  neutropenia (ANC &lt; 1)&#xD;
&#xD;
               -  ongoing use of systemic corticosteroids &gt; 30 mg/day&#xD;
&#xD;
               -  ongoing use of biologic therapy&#xD;
&#xD;
               -  undergoing chemotherapy, received chemotherapy ≤ 30 days from baseline visit, or&#xD;
                  expected to undergo chemotherapy in the upcoming 12 months&#xD;
&#xD;
               -  active hematologic malignancy&#xD;
&#xD;
               -  solid organ transplant recipient&#xD;
&#xD;
               -  hematopoetic stem cell transplant recipient&#xD;
&#xD;
               -  HIV positive patients with cluster differentiation 4 (CD4) cell count &lt; 350&#xD;
&#xD;
          5. Patients with ascites or receiving peritoneal dialysis.&#xD;
&#xD;
          6. History of inflammatory bowel disease (Crohn's or Ulcerative colitis).&#xD;
&#xD;
          7. Chronic diarrhea or active colitis for any reason.&#xD;
&#xD;
          8. Ileus or active gastrointestinal motility disorder at baseline.&#xD;
&#xD;
          9. History of total colectomy.&#xD;
&#xD;
         10. Severe, irreversible bleeding disorder.&#xD;
&#xD;
         11. History of anaphylactic or anaphylactoid allergic reaction to any foods.&#xD;
&#xD;
         12. Anticipated life expectancy less than 6 months.&#xD;
&#xD;
         13. Unable to tolerate enema.&#xD;
&#xD;
         14. Participant is not a Canadian citizen or permanent resident, and not expected to&#xD;
             remain in Toronto region for 12 months.&#xD;
&#xD;
         15. Any reason in the view of the investigator.&#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>Susy S. Hota, MD MSc FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Infectious Diseases Physician, University Health Network</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Susan M. Poutanen, MD MPH FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Microbiologist &amp; Infectious Disease Physician, Sinai Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Osler Health System</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6R 3J7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joseph Brant Hospital</name>
      <address>
        <city>Burlington</city>
        <state>Ontario</state>
        <zip>L7S 1W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeridge Health</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1G 2B9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MacKenzie Health</name>
      <address>
        <city>Richmond Hill</city>
        <state>Ontario</state>
        <zip>L4C 4Z3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Scarborough Hospital</name>
      <address>
        <city>Scarborough</city>
        <state>Ontario</state>
        <zip>M1P 2T7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North York General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M2K 1E1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael Garron Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4C 3E7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B 1W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Public Health Ontario Laboratories</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sinai Health System</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Health Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6R 1B5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 8, 2018</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Health Network, Toronto</investigator_affiliation>
    <investigator_full_name>Susy Hota</investigator_full_name>
    <investigator_title>Medical Director, Infection Prevention and Control</investigator_title>
  </responsible_party>
  <keyword>Fecal Microbiota Transplantation</keyword>
  <keyword>Gut Microbiome</keyword>
  <keyword>Carbapenemase-producing Enterobacteriaceae (CPE)</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03802461
org study id: 18-5177
nct id: NCT03802461
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Carbapenemase-producing Enterobacteriaceae (CPE) are bacteria carried in the gastrointestinal
      tract that are resistant to carbapenems, antibiotics of last resort. CPE infections result in
      death in 25-50% of cases. Fecal microbiota transplantation (FMT) is the transfer of stool
      from a healthy donor to a recipient to alter the composition of gut microbes. Early studies
      support its use for eliminating CPE carriage but definitive studies are lacking. The
      investigators propose a feasibility pilot for a multicenter, non-blinded randomized trial
      comparing the effectiveness of FMT with no intervention (standard of care) in eliminating
      intestinal carriage of CPE. Forty patients with CPE will be randomly assigned to receive FMT
      by enema or no intervention. Feasibility will be demonstrated by the ability to recruit and
      retain 40 patients over 12 months, and to provide FMT made at a central site to at least one
      off-site hospital. The primary clinical endpoint for the full trial is CPE intestinal
      carriage 3 months after the intervention. Secondary endpoints include: CPE carriage at 1, 6
      and 12 months; time to decolonization of CPE; safety; CPE infections over 12 months; and,
      intestinal carriage of other antibiotic-resistant organisms. Data on the clinical outcomes
      will be collected but not analyzed in this feasibility study.
This is a multisite, open-label randomized controlled internal pilot trial designed to assess
      the feasibility of a larger trial aimed at determining the effectiveness of fecal microbiota
      transplantation (FMT) by enema in short and long term intestinal decolonization of
      carbapenemase-producing Enterobacteriaceae (CPE). Forty (40) asymptomatic adult patients
      intestinally colonized with CPE will be allocated in a 1:1 ratio to receive a bowel
      preparation followed by FMT by enema route, versus standard of care (no intervention). FMT
      will be provided by the University of Toronto Microbiota Therapeutics Outcomes Program
      (MTOP), using standardized operating procedures for recruiting and screening FMT donors,
      manufacturing FMT and administering FMT by enema. The feasibility outcomes are: successful
      randomization of 40 patients within 12 months, retention of >90% (36/40) of patients up to 6
      months, and provision of FMT at a non-primary study site in at least one patient. Data on the
      clinical and exploratory outcomes will be collected but not analyzed in this pilot study. The
      primary clinical outcome is incidence of intestinal decolonization of CPE at 3 months.
      Secondary clinical outcomes include: time to decolonization of CPE; incidence of CPE clinical
      infections up to 12 months post-intervention; incidence of intestinal decolonization of CPE
      and other antibiotic-resistant organisms (extended spectrum beta-lactamase Enterobacteriaceae
      - ESBLs and vancomycin-resistant Enterococci - VRE) at 1, 3, 6 and 12 months
      post-intervention; and, safety profile. As an exploratory outcome, changes in fecal
      microbiome composition will be examined before and after intervention. This study leverages
      existing support, research infrastructures and expertise - including the Toronto Invasive
      Bacterial Diseases Network (TIBDN), Toronto Antimicrobial Resistance Research Network
      (TARRN), and the University of Toronto Microbiota Therapeutics Outcomes Program (MTOP) - to
      optimize feasibility regarding patient recruitment and FMT administration.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Asymptomatic adult patients intestinally colonized with CPE will either randomized to receive fecal microbiota transplantation (intervention) or standard of care (no intervention).
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of intestinal colonization of patients with CPE 3 months after intervention.
time frame: 3 months
description: Incidence of CPE colonization in FMT arm vs control arm at 3 months
measure: Randomization rate in study
time frame: 12 months
description: Completion of randomization of 40 study participants during the study period will be used to indicate feasibility of the study.
measure: Proportion of patients retained in study for up to 6 months
time frame: 6 months
description: A retention of 90% of patients up to 6 months in the study will be used to indicate feasibility.
measure: Incidence of CPE decolonization in FMT-treatment and non-treatment groups at 1, 6 and 12 months.
time frame: 1, 6, and 12 months
description: As above
measure: Time to CPE decolonization in FMT-treatment and non-treatment groups.
time frame: 1, 3, 6, and 12 months
description: As above
measure: Incidence of CPE clinical infection in FMT treatment and non-treatment groups over 12 months.
time frame: 1, 3, 6, and 12 months
description: As above
measure: Incidence of extended spectrum beta-lactamase organisms (ESBL) and vancomycin-resistant Enterococci (VRE) intestinal colonization at 0, 1, 3, 6 and 12 months in FMT treatment and non-treatment groups.
time frame: 1, 3, 6, and 12 months
description: Changes in colonization status of other antimicrobial resistant organisms over the study period
measure: Incidence of solicited and unsolicited adverse and serious adverse events in both groups
time frame: 3 months
description: Participants will be asked to report adverse and serious adverse events will be throughout the study period and will be asked specifically about adverse events during study visits
measure: Number of patients with all-cause mortality at 30 days post-randomization
time frame: 1 month
description: As above
measure: Changes in composition and diversity of fecal bacterial phyla (as measured by 16s ribosomal ribonucleic acid sequencing) in both intervention groups
time frame: 12 months
description: As above
arm group label: Fecal Microbiota Transplantation (FMT)
arm group type: Active Comparator
description: Bowel lavage preparation followed by FMT administered by enema, given on 3 occasions. Fecal filtrate for FMT will be prepared from 50 g of healthy donor stool, homogenized, and diluted in 300 mL sterile normal saline.
arm group label: Standard of Care
arm group type: No Intervention
description: Patients in this arm will not receive intervention and will be on standard of care .
intervention type: Biological
intervention name: Fecal Microbiota Transplantation (FMT)
description: Feces from healthy donor
arm group label: Fecal Microbiota Transplantation (FMT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susy S. Hota, MD MSc FRCPC
role: Principal Investigator
affiliation: Infectious Diseases Physician, University Health Network
last name: Susan M. Poutanen, MD MPH FRCPC
role: Principal Investigator
affiliation: Microbiologist & Infectious Disease Physician, Sinai Health System
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: University Health Network, Toronto
investigator full name: Susy Hota
investigator title: Medical Director, Infection Prevention and Control
sharing ipd: No