<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/NCT03032042</url>
  </required_header>
  <id_info>
    <org_study_id>17-0101</org_study_id>
    <nct_id>NCT03032042</nct_id>
  </id_info>
  <brief_title>Intestinal Microbiome Post-Azythromycin/Albendazole Treatment</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond&#xD;
      targeted PCR testing to next generation sequencing techniques. In addition, the current state&#xD;
      of monitoring for soil-transmitted helminth infections is moving increasingly from&#xD;
      microscopic techniques to molecular techniques. The targeted PCR test for soil transmitted&#xD;
      helminth diagnosis has been validated on stool samples, but not rectal swabs. Bulk stool&#xD;
      samples are logistically challenging and time-intensive to collect, thus participation is&#xD;
      often far from optimal. Rectal swabs are more efficient and may result in higher&#xD;
      participation. In this study, children will be randomized to either albendazole,&#xD;
      azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be&#xD;
      collected. The investigators will compare the PCR test for soil transmitted helminth&#xD;
      infections using both the rectal swabs and the bulk stool samples. In addition, the&#xD;
      investigators will analyze the gut microbiome of the children using next generation&#xD;
      sequencing techniques to gain insight into effects of mass drug administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    We were not able to secure IRB approval in the timeline necessary to do this study.&#xD;
  </why_stopped>
  <start_date type="Anticipated">January 2017</start_date>
  <completion_date type="Anticipated">February 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Microbial diversity in the intestinal microbiomes of children aged 1-60 months</measure>
    <time_frame>Day 7</time_frame>
    <description>Microbiota diversity in the intestinal microbiomes of children aged 1-60 months in azithromycin-treated, albendazole-treated, azithromycin+albendazole-treated and delayed treatment arms using phylogenetic distance measures</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5</measure>
    <time_frame>Day 7</time_frame>
    <description>The investigators use PCR to identify soil transmitted helming infections in rectal swab samples and bulk stool sample from the same child. Using the bulk stool sample as the gold standard, the investigators will calculate the sensitivity, specificity, PPV, and NPV of the rectal swabs for detecting the various helminth infections.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Helminth Infection</condition>
  <arm_group>
    <arm_group_label>albendazole at day 0, azithromycin at day 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>azithromycin at day 0, albendazole at day 7</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>albendazole at day 0, azithromycin at day 0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed treatment</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>albendazole at day 7, azithromycin at day 7</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <arm_group_label>albendazole at day 0, azithromycin at day 0</arm_group_label>
    <arm_group_label>azithromycin at day 0, albendazole at day 7</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Albendazole</intervention_name>
    <arm_group_label>albendazole at day 0, azithromycin at day 0</arm_group_label>
    <arm_group_label>albendazole at day 0, azithromycin at day 7</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Delayed treatment</intervention_name>
    <description>Albendazole+Azithromycin</description>
    <arm_group_label>Delayed treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all children 0 to 5 (up to 6th birthday)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  individuals with a macrolide allergy&#xD;
&#xD;
          -  refusal of parent/guardian&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeremy Keenan, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>F.I. Proctor Foundation, University of California San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Carter Center Ethiopia</name>
      <address>
        <city>Addis Ababa</city>
        <country>Ethiopia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ethiopia</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>January 8, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>June 23, 2021</last_update_submitted>
  <last_update_submitted_qc>June 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intestinal microbiome</keyword>
  <keyword>soil-transmitted helminths</keyword>
  <keyword>mass drug administration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Helminthiasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Albendazole</mesh_term>
  </intervention_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/NCT03032042
org study id: 17-0101
nct id: NCT03032042
lead sponsor: 
has dmc: Yes
Molecular testing of the gut microbiome and enteric pathogens is rapidly moving beyond
      targeted PCR testing to next generation sequencing techniques. In addition, the current state
      of monitoring for soil-transmitted helminth infections is moving increasingly from
      microscopic techniques to molecular techniques. The targeted PCR test for soil transmitted
      helminth diagnosis has been validated on stool samples, but not rectal swabs. Bulk stool
      samples are logistically challenging and time-intensive to collect, thus participation is
      often far from optimal. Rectal swabs are more efficient and may result in higher
      participation. In this study, children will be randomized to either albendazole,
      azithromycin, or both drugs, after which both rectal swabs and bulk stool samples will be
      collected. The investigators will compare the PCR test for soil transmitted helminth
      infections using both the rectal swabs and the bulk stool samples. In addition, the
      investigators will analyze the gut microbiome of the children using next generation
      sequencing techniques to gain insight into effects of mass drug administration.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Diagnostic
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Microbial diversity in the intestinal microbiomes of children aged 1-60 months
time frame: Day 7
description: Microbiota diversity in the intestinal microbiomes of children aged 1-60 months in azithromycin-treated, albendazole-treated, azithromycin+albendazole-treated and delayed treatment arms using phylogenetic distance measures
measure: Sensitivity of Soil-transmitted helminth infection detection in rectal swab versus bulk stool sample in children 0-5
time frame: Day 7
description: The investigators use PCR to identify soil transmitted helming infections in rectal swab samples and bulk stool sample from the same child. Using the bulk stool sample as the gold standard, the investigators will calculate the sensitivity, specificity, PPV, and NPV of the rectal swabs for detecting the various helminth infections.
arm group label: albendazole at day 0, azithromycin at day 7
arm group type: Experimental
arm group label: azithromycin at day 0, albendazole at day 7
arm group type: Experimental
arm group label: albendazole at day 0, azithromycin at day 0
arm group type: Experimental
arm group label: Delayed treatment
arm group type: Other
description: albendazole at day 7, azithromycin at day 7
intervention type: Drug
intervention name: Azithromycin
arm group label: albendazole at day 0, azithromycin at day 0
arm group label: azithromycin at day 0, albendazole at day 7
intervention type: Drug
intervention name: Albendazole
arm group label: albendazole at day 0, azithromycin at day 0
arm group label: albendazole at day 0, azithromycin at day 7
intervention type: Drug
intervention name: Delayed treatment
description: Albendazole+Azithromycin
arm group label: Delayed treatment
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeremy Keenan, MD, MPH
role: Principal Investigator
affiliation: F.I. Proctor Foundation, University of California San Francisco
facility: 
country: Ethiopia
responsible party type: Sponsor
mesh term: Helminthiasis
mesh term: Azithromycin
mesh term: Albendazole