<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/NCT03778125</url>
  </required_header>
  <id_info>
    <org_study_id>21166</org_study_id>
    <secondary_id>PR-18078</secondary_id>
    <nct_id>NCT03778125</nct_id>
  </id_info>
  <brief_title>Multidrug Resistant Shigella Infection in Bangladesh</brief_title>
  <official_title>Clinical and Microbiologic Outcomes in Patients Treated for Multidrug-resistant Shigella Infections in Dhaka, Bangladesh</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Centre for Diarrhoeal Disease Research, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Virginia</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>
      The purpose of this project is to systematically collect clinical and nutritional outcomes&#xD;
      information on patients treated for Shigella infection so that physicians and clinical&#xD;
      laboratories can better define which Shigella infections are &quot;resistant&quot; to antibiotics and&#xD;
      which are &quot;susceptible&quot;, focusing on azithromycin a last-line drug to treat drug resistant&#xD;
      Shigella&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2000 suspected Shigella cases will be recruited from International Centre for Diarrhoeal&#xD;
      Disease Research hospital, Dhaka who are presenting with diarrhea at the hospital. A stool&#xD;
      sample will be collected from the participants after consenting by the study staff. Stool&#xD;
      microscopy will be performed to see the white blood cells(WBC) and red blood cells (RBC). If&#xD;
      WBC &gt; 10 HPF (4) with any RBC present, culture will be performed from this stool to identify&#xD;
      Shigella. Such patients with invasive diarrhea are treated with azithromycin per local&#xD;
      standard of care. Enrolled participant will be invited for further follow up when culture&#xD;
      from the stool is Shigella positive. Minimal inhibitory concentration (MIC) testing of&#xD;
      Shigella isolates and Molecular testing of Shigella isolates will be performed from Shigella&#xD;
      cultures. This is an observational study. This study does not provide any treatment to the&#xD;
      study participants; they will receive treatment as per International Centre for Diarrhoeal&#xD;
      Disease Research Dhaka hospital guidelines. We will then examine the effect of the&#xD;
      azithromycin minimal inhibitory concentration on clinical outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">December 13, 2018</start_date>
  <completion_date type="Anticipated">January 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Clinical outcome: resolution of diarrhea</measure>
    <time_frame>Day 5</time_frame>
    <description>resolution of diarrhea as measured by the participant through a memory aid</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Microbiologic outcome: Shigella negative cultures</measure>
    <time_frame>Day 5</time_frame>
    <description>Proportion shigella culture negative isolates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients that have complications</measure>
    <time_frame>day 5</time_frame>
    <description>required hospitalization or have extraintestinal complications</description>
  </secondary_outcome>
  <other_outcome>
    <measure>time to last unformed stool</measure>
    <time_frame>Day 5</time_frame>
    <description>duration of diarrhea in days</description>
  </other_outcome>
  <other_outcome>
    <measure>fever</measure>
    <time_frame>Day 5</time_frame>
    <description>duration of fever in days</description>
  </other_outcome>
  <other_outcome>
    <measure>bloody stool</measure>
    <time_frame>Day 5</time_frame>
    <description>duration of bloody stool in days</description>
  </other_outcome>
  <other_outcome>
    <measure>difference in invasion plasmid antigen H (ipaH)</measure>
    <time_frame>Day 5</time_frame>
    <description>molecular detection of Shigella quantity</description>
  </other_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Diarrhea</condition>
  <condition>Shigella</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Stool culture positive for Shigella&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        2000 suspected Shigella cases will be recruited from International Centre for Diarrhoeal&#xD;
        Disease Research hospital, Dhaka who are presenting with diarrhea at the hospital. A stool&#xD;
        sample will be collected from the participants after consenting by the study staff. Stool&#xD;
        microscopy will be performed to see the white blood cells (WBC). If WBC &gt; 10 HPF (4)&#xD;
        culture will be performed from this stool to identify Shigella. Such patients with invasive&#xD;
        diarrhea are treated with azithromycin per local standard of care. Enrolled participant&#xD;
        will be invited for further follow up when culture from the stool is Shigella positive.&#xD;
        Minimal inhibitory concentration (MIC) testing of Shigella isolates and Molecular testing&#xD;
        of Shigella isolates will be performed from Shigella cultures.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diarrheal illness less than 96 hours duration&#xD;
&#xD;
          -  microscopic evidence of inflammatory diarrhea&#xD;
&#xD;
          -  plus mucus in stool&#xD;
&#xD;
          -  plus abdominal pain/cramps&#xD;
&#xD;
          -  Subject or parents or legal guardian willing to come for follow up at hospital or&#xD;
             allow study staff for home visit&#xD;
&#xD;
          -  residence in Dhaka region&#xD;
&#xD;
          -  presentation during daytime hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Not receiving treatment with azithromycin at enrolment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric R Houpt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>International Centre for Diarrhoeal Disease Research</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Eric R. Houpt, MD</investigator_full_name>
    <investigator_title>Jack Gwaltney Professor of Infectious Diseases</investigator_title>
  </responsible_party>
  <keyword>multidrug resistant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dysentery, Bacillary</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <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/NCT03778125
org study id: 21166
secondary id: PR-18078
nct id: NCT03778125
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this project is to systematically collect clinical and nutritional outcomes
      information on patients treated for Shigella infection so that physicians and clinical
      laboratories can better define which Shigella infections are "resistant" to antibiotics and
      which are "susceptible", focusing on azithromycin a last-line drug to treat drug resistant
      Shigella
2000 suspected Shigella cases will be recruited from International Centre for Diarrhoeal
      Disease Research hospital, Dhaka who are presenting with diarrhea at the hospital. A stool
      sample will be collected from the participants after consenting by the study staff. Stool
      microscopy will be performed to see the white blood cells(WBC) and red blood cells (RBC). If
      WBC > 10 HPF (4) with any RBC present, culture will be performed from this stool to identify
      Shigella. Such patients with invasive diarrhea are treated with azithromycin per local
      standard of care. Enrolled participant will be invited for further follow up when culture
      from the stool is Shigella positive. Minimal inhibitory concentration (MIC) testing of
      Shigella isolates and Molecular testing of Shigella isolates will be performed from Shigella
      cultures. This is an observational study. This study does not provide any treatment to the
      study participants; they will receive treatment as per International Centre for Diarrhoeal
      Disease Research Dhaka hospital guidelines. We will then examine the effect of the
      azithromycin minimal inhibitory concentration on clinical outcome.
observational model: Cohort
time perspective: Prospective
measure: Clinical outcome: resolution of diarrhea
time frame: Day 5
description: resolution of diarrhea as measured by the participant through a memory aid
measure: Microbiologic outcome: Shigella negative cultures
time frame: Day 5
description: Proportion shigella culture negative isolates
measure: Proportion of patients that have complications
time frame: day 5
description: required hospitalization or have extraintestinal complications
measure: time to last unformed stool
time frame: Day 5
description: duration of diarrhea in days
measure: fever
time frame: Day 5
description: duration of fever in days
measure: bloody stool
time frame: Day 5
description: duration of bloody stool in days
measure: difference in invasion plasmid antigen H (ipaH)
time frame: Day 5
description: molecular detection of Shigella quantity
Stool culture positive for Shigella
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Eric R Houpt, MD
role: Principal Investigator
affiliation: University of Virginia
facility: 
country: Bangladesh
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Eric R. Houpt, MD
investigator title: Jack Gwaltney Professor of Infectious Diseases
mesh term: Dysentery, Bacillary
mesh term: Diarrhea
sharing ipd: No