<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/NCT03794453</url>
  </required_header>
  <id_info>
    <org_study_id>STM_protocol_v1_20180411</org_study_id>
    <nct_id>NCT03794453</nct_id>
  </id_info>
  <brief_title>Intestinal Microbiota and Antimicrobial Resistance</brief_title>
  <official_title>Longitudinal Changes in Intestinal Microbiota and Its Association With Acquisition of Antimicrobial Resistance in a Cohort of Stroke Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Antimicrobial resistance is regarded as one of the major global public health threats,&#xD;
      causing at least 700,000 deaths per year. It has been estimated that if the current problem&#xD;
      of antimicrobial resistance is not effectively tackled, it would cause the death of 10&#xD;
      million people worldwide by 2050. Multi-drug resistant pathogen is the single most important&#xD;
      contributing factor for inappropriate antibiotics therapy, and this in turn lead to higher&#xD;
      mortality in patients with sepsis. The slow pace of development of new classes of&#xD;
      antimicrobial agents limits the availability of effective therapy for multi-drug resistant&#xD;
      organisms, both currently and in the near future. It is therefore of utmost importance to&#xD;
      look for strategies to reduce the spread and burden of antimicrobial resistance.&#xD;
&#xD;
      Intestinal microbiota probably played a dominant role in determining the risk of acquisition&#xD;
      of multi-drug resistant organisms. For instance, findings from a mouse model showed that&#xD;
      Barnesiella species conferred resistance to intestinal colonization by vancomycinresistant&#xD;
      Enterococcus. Such findings were subsequently confirmed in human subjects.&#xD;
&#xD;
      This is a prospective longitudinal observational study evaluating the correlation between&#xD;
      changes in intestinal microbiota and acquisition of antimicrobial resistance in patients&#xD;
      hospitalized for stroke.&#xD;
&#xD;
      Adult patients admitted to the Medical unit of the Prince of Wales Hospital with a diagnosis&#xD;
      of acute stroke will be screened for eligibility and will be invited to participate in this&#xD;
      study. Data collected from this study will determine the correlation between antibiotics use&#xD;
      and changes in intestinal microbiota in a cohort of hospitalized patients as well as the&#xD;
      correlation between intestinal microbiota and acquisition of intestinal colonization or&#xD;
      infection caused by resistant pathogens.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 6, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2024</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>Proportion of patients acquiring intestinal colonization of resistant organisms</measure>
    <time_frame>2 years</time_frame>
    <description>Intestinal colonization of resistant organisms are defined as the presence of ESBL or resistance to one or more carbapenems in Enterobacteriaceae identified in the stool samples, in patients without these organisms detected in their stool samples at the time of admission to hospital.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients acquiring nosocomial infections secondary to multi-drug resistant pathogens.</measure>
    <time_frame>2 years</time_frame>
    <description>Nosocomial infections are defined as infections with onset of 72 hours or more after hospital admission.&#xD;
Multi-drug resistant pathogens are defined as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus species, ESBL-producing Enterobacteriaceae, and carbapenem-resistant Gram-negative bacteria, including Enterobacteriaceae, Acinetobacter species, and Pseudomonas aeruginosa, detected in one or more of patients' clinical specimens.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Drug Resistance, Microbial</condition>
  <arm_group>
    <arm_group_label>Stroke patients</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool samples for microbiota analysis&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients with a diagnosis of acute stroke&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 years or above, and&#xD;
&#xD;
          -  Radiological evidence of acute ischaemic or hemorrhagic stroke&#xD;
&#xD;
          -  Within two days of hospital admission&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of antibiotics within 4 weeks prior to the time of screening&#xD;
&#xD;
          -  Underlying gastrointestinal diseases, including gastrointestinal malignancy,&#xD;
             inflammatory bowel disease, resection of small or large bowel&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Prince of Wales Hospital</name>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grace Lui</last_name>
      <phone>35053376</phone>
      <email>gracelui@cuhk.edu.hk</email>
    </contact>
    <contact_backup>
      <last_name>Rity Wong</last_name>
      <phone>35053376</phone>
      <email>ritywong@cuhk.edu.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Grace Lui</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Stroke</keyword>
  <keyword>Intestinal microbiota</keyword>
  <keyword>Antimicrobial resistance</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03794453
org study id: STM_protocol_v1_20180411
nct id: NCT03794453
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Antimicrobial resistance is regarded as one of the major global public health threats,
      causing at least 700,000 deaths per year. It has been estimated that if the current problem
      of antimicrobial resistance is not effectively tackled, it would cause the death of 10
      million people worldwide by 2050. Multi-drug resistant pathogen is the single most important
      contributing factor for inappropriate antibiotics therapy, and this in turn lead to higher
      mortality in patients with sepsis. The slow pace of development of new classes of
      antimicrobial agents limits the availability of effective therapy for multi-drug resistant
      organisms, both currently and in the near future. It is therefore of utmost importance to
      look for strategies to reduce the spread and burden of antimicrobial resistance.

      Intestinal microbiota probably played a dominant role in determining the risk of acquisition
      of multi-drug resistant organisms. For instance, findings from a mouse model showed that
      Barnesiella species conferred resistance to intestinal colonization by vancomycinresistant
      Enterococcus. Such findings were subsequently confirmed in human subjects.

      This is a prospective longitudinal observational study evaluating the correlation between
      changes in intestinal microbiota and acquisition of antimicrobial resistance in patients
      hospitalized for stroke.

      Adult patients admitted to the Medical unit of the Prince of Wales Hospital with a diagnosis
      of acute stroke will be screened for eligibility and will be invited to participate in this
      study. Data collected from this study will determine the correlation between antibiotics use
      and changes in intestinal microbiota in a cohort of hospitalized patients as well as the
      correlation between intestinal microbiota and acquisition of intestinal colonization or
      infection caused by resistant pathogens.
observational model: Cohort
time perspective: Prospective
measure: Proportion of patients acquiring intestinal colonization of resistant organisms
time frame: 2 years
description: Intestinal colonization of resistant organisms are defined as the presence of ESBL or resistance to one or more carbapenems in Enterobacteriaceae identified in the stool samples, in patients without these organisms detected in their stool samples at the time of admission to hospital.
measure: Proportion of patients acquiring nosocomial infections secondary to multi-drug resistant pathogens.
time frame: 2 years
description: Nosocomial infections are defined as infections with onset of 72 hours or more after hospital admission.
Multi-drug resistant pathogens are defined as methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus species, ESBL-producing Enterobacteriaceae, and carbapenem-resistant Gram-negative bacteria, including Enterobacteriaceae, Acinetobacter species, and Pseudomonas aeruginosa, detected in one or more of patients' clinical specimens.
arm group label: Stroke patients
Stool samples for microbiota analysis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Grace Lui
investigator title: Assistant Professor
sharing ipd: Undecided